DownloadHi-Res Photo

Ian Krop, MD, PhD

Professor of Internal Medicine (Medical Oncology); Director, Clinical Trials Office; Chief Clinical Research Officer, Yale Cancer Center; Associate Director, Clinical Sciences, Yale Cancer Center

Research & Publications
Biography
News

Research Summary

His research efforts have advanced the field through clinical trials that define the next generation of therapies for patients. Dr. Krop serves as a member of the NCI Breast Cancer Steering Committee and the Data Monitoring Committee for ECOG/ACRIN. He also serves on the Data and Safety Monitoring Boards for multiple phase III trials.

Coauthors

Research Interests

Breast Diseases

Selected Publications

Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trialsRediti M, Fernandez-Martinez A, Venet D, Rothé F, Hoadley K, Parker J, Singh B, Campbell J, Ballman K, Hillman D, Winer E, El-Abed S, Piccart M, Di Cosimo S, Symmans W, Krop I, Salgado R, Loi S, Pusztai L, Perou C, Carey L, Sotiriou C. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials. Nature Communications 2023, 14: 7053. PMID: 37923752, PMCID: PMC10624889, DOI: 10.1038/s41467-023-42635-2.
Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3–Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3–Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II TrialKrop I, Masuda N, Mukohara T, Takahashi S, Nakayama T, Inoue K, Iwata H, Yamamoto Y, Alvarez R, Toyama T, Takahashi M, Osaki A, Saji S, Sagara Y, O'Shaughnessy J, Ohwada S, Koyama K, Inoue T, Li L, Patel P, Mostillo J, Tanaka Y, Sternberg D, Sellami D, Yonemori K. Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3–Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3–Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial. Journal Of Clinical Oncology 2023, 41: 5550-5560. PMID: 37801674, PMCID: PMC10730028, DOI: 10.1200/jco.23.00882.
377O A pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with brain metastases (BMs) from DESTINY-Breast (DB) -01, -02, and -03Hurvitz S, Modi S, Li W, Park Y, Chung W, Kim S, Cortés J, Yamashita T, Pedrini J, Im S, Tseng L, Harbeck N, Krop I, Curigliano G, Mathias E, Cathcart J, Cagnazzo A, Ashfaque S, Egorov A, André F. 377O A pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with brain metastases (BMs) from DESTINY-Breast (DB) -01, -02, and -03. Annals Of Oncology 2023, 34: s335-s336. DOI: 10.1016/j.annonc.2023.09.554.
Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial)Hennessy M, Leal J, Huang C, Solnes L, Denbow R, Abramson V, Carey L, Liu M, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Cimino-Mathews A, Wahl R, Stearns V, Connolly R. Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial). Journal Of Nuclear Medicine 2023, 64: jnumed.123.265853. PMID: 37652539, DOI: 10.2967/jnumed.123.265853.
Circulating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆Parsons H, Blewett T, Chu X, Sridhar S, Santos K, Xiong K, Abramson V, Patel A, Cheng J, Brufsky A, Rhoades J, Force J, Liu R, Traina T, Carey L, Rimawi M, Miller K, Stearns V, Specht J, Falkson C, Burstein H, Wolff A, Winer E, Tayob N, Krop I, Makrigiorgos G, Golub T, Mayer E, Adalsteinsson V. Circulating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆. Annals Of Oncology 2023, 34: 899-906. PMID: 37597579, PMCID: PMC10898256, DOI: 10.1016/j.annonc.2023.08.004.
Assessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and PertuzumabWaks A, Ogayo E, Paré L, Marín-Aguilera M, Brasó-Maristany F, Galván P, Castillo O, Martínez-Sáez O, Vivancos A, Villagrasa P, Villacampa G, Tarantino P, Desai N, Guerriero J, Metzger O, Tung N, Krop I, Parker J, Perou C, Prat A, Winer E, Tolaney S, Mittendorf E. Assessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab. JAMA Oncology 2023, 9: 835-840. PMID: 37103927, PMCID: PMC10141272, DOI: 10.1001/jamaoncol.2023.0181.
Trends in breast cancer death by stage at diagnoses in 2000-2018.Kahn A, Marczyk M, Silber A, Rozenblit M, Sanft T, DiGiovanna M, Schellhorn S, Krop I, Lustberg M, Winer E, Pusztai L. Trends in breast cancer death by stage at diagnoses in 2000-2018. Journal Of Clinical Oncology 2023, 41: e18855-e18855. DOI: 10.1200/jco.2023.41.16_suppl.e18855.
Phase II trial of pembrolizumab in patients with brain metastases.Brastianos P, Kim A, Giobbie-Hurder A, Lee E, Lin N, Overmoyer B, Wen P, Nayak L, Cohen J, Dietrich J, Heist R, Krop I, Lawrence D, Mayer E, Winer E, Shih H, Oh K, Cahill D, Gerstner E, Sullivan R. Phase II trial of pembrolizumab in patients with brain metastases. Journal Of Clinical Oncology 2023, 41: 2006-2006. DOI: 10.1200/jco.2023.41.16_suppl.2006.
An age-specific pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03.Krop I, Wildiers H, Hurvitz S, Cortes J, Im S, Iwata H, Andre F, Saura C, Modi S, Kim S, Egorov A, Mathias E, Cathcart J, Cagnazzo A, Cheng Y, Park Y. An age-specific pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03. Journal Of Clinical Oncology 2023, 41: 1006-1006. DOI: 10.1200/jco.2023.41.16_suppl.1006.
Genomics of ERBB2-Positive Breast Cancer in Young Women Before and After Exposure to Chemotherapy Plus Trastuzumab.Lipsyc-Sharf M, Jain E, Collins L, Rosenberg S, Ruddy K, Tamimi R, Schapira L, Come S, Peppercorn J, Borges V, Warner E, Snow C, Krop I, Kim D, Weiss J, Zanudo J, Partridge A, Wagle N, Waks A. Genomics of ERBB2-Positive Breast Cancer in Young Women Before and After Exposure to Chemotherapy Plus Trastuzumab. JCO Precision Oncology 2023, 7: e2300076. PMID: 37364233, DOI: 10.1200/po.23.00076.
Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial.Weiss A, Li T, Desai N, Tung N, Poorvu P, Partridge A, Nakhlis F, Dominici L, Sinclair N, Spring L, Faggen M, Constantine M, Krop I, DeMeo M, Wrabel E, Alberti J, Chikarmane S, Tayob N, King T, Tolaney S, Winer E, Mittendorf E, Waks A. Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial. Journal Of The American College Of Surgeons 2023, 237: 247-256. PMID: 37194964, DOI: 10.1097/xcs.0000000000000761.
A Multiparameter Molecular Classifier to Predict Response to Neoadjuvant Lapatinib plus Trastuzumab without Chemotherapy in HER2+ Breast Cancer.Veeraraghavan J, Gutierrez C, De Angelis C, Davis R, Wang T, Pascual T, Selenica P, Sanchez K, Nitta H, Kapadia M, Pavlick A, Galvan P, Rexer B, Forero-Torres A, Nanda R, Storniolo A, Krop I, Goetz M, Nangia J, Wolff A, Weigelt B, Reis-Filho J, Hilsenbeck S, Prat A, Osborne C, Schiff R, Rimawi M. A Multiparameter Molecular Classifier to Predict Response to Neoadjuvant Lapatinib plus Trastuzumab without Chemotherapy in HER2+ Breast Cancer. Clinical Cancer Research 2023, 29: 3101-3109. PMID: 37195235, PMCID: PMC10923553, DOI: 10.1158/1078-0432.ccr-22-3753.
6P Combined analysis of the HER2DX genomic tool in adjuvant APT and ATEMPT trialsTarantino P, Villacampa G, Graham N, Waks A, Gonzalez P, Brasó-Maristany F, Torres E, Galván P, Brunet L, Demeo M, Partridge A, Burstein H, Krop I, Tayob N, Winer E, Prat A, Tolaney S. 6P Combined analysis of the HER2DX genomic tool in adjuvant APT and ATEMPT trials. ESMO Open 2023, 8: 101230. DOI: 10.1016/j.esmoop.2023.101230.
186O Patient-reported outcomes (PROs) from DESTINY-Breast02, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2–positive (HER2+) metastatic breast cancer (mBC)Fehm T, Cottone F, Dunton K, André F, Krop I, Park Y, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego M, Yerushalmi R, Duhoux F, Takano T, Lu W, Livings C, Egorov A, Kim S. 186O Patient-reported outcomes (PROs) from DESTINY-Breast02, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2–positive (HER2+) metastatic breast cancer (mBC). ESMO Open 2023, 8: 101375. DOI: 10.1016/j.esmoop.2023.101375.
Multiple PIK3CA mutation clonality correlates with outcomes in taselisib + fulvestrant-treated ER+/HER2–, PIK3CA-mutated breast cancersHutchinson K, Chen J, Savage H, Stout T, Schimmoller F, Cortés J, Dent S, Harbeck N, Jacot W, Krop I, Trabucco S, Sivakumar S, Sokol E, Wilson T. Multiple PIK3CA mutation clonality correlates with outcomes in taselisib + fulvestrant-treated ER+/HER2–, PIK3CA-mutated breast cancers. Genome Medicine 2023, 15: 28. PMID: 37101291, PMCID: PMC10131374, DOI: 10.1186/s13073-023-01181-8.
Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trialAndré F, Hee Park Y, Kim S, Takano T, Im S, Borges G, Lima J, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux F, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. The Lancet 2023, 401: 1773-1785. PMID: 37086745, DOI: 10.1016/s0140-6736(23)00725-0.
Abstract 3874: Genomic mechanisms of resistance to tyrosine kinase inhibitors (TKIs) in HER2+ metastatic breast cancer (HER2+ MBC)Parsons H, Messer C, Santos K, Danysh B, Hughes M, Patel A, Jacobs R, Slowik K, Hess J, Stewart C, Schlueter-Kuck K, Rhrissorrakrai K, Utro F, Levovitz C, Wagle N, Leone J, Freedman R, Parida L, Krop I, Getz G, Lin N. Abstract 3874: Genomic mechanisms of resistance to tyrosine kinase inhibitors (TKIs) in HER2+ metastatic breast cancer (HER2+ MBC). Cancer Research 2023, 83: 3874-3874. DOI: 10.1158/1538-7445.am2023-3874.
Abstract 5559: Exploratory analysis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) PIK3CA mutated (mut) advanced breast cancer (aBC) treated with taselisib (TAS) and/or fulvestrant (FUL) reveals increased CCNE2 expression with poor outcome to placebo (PBO) + FUL but not TAS + FUL in SANDPIPERJohnson R, Liu B, Cortés J, Dent S, Harbeck N, Krop I, Jacot W, Yauch R, Stout T, Schimmoller F, Gendreau S, Wilson T. Abstract 5559: Exploratory analysis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) PIK3CA mutated (mut) advanced breast cancer (aBC) treated with taselisib (TAS) and/or fulvestrant (FUL) reveals increased CCNE2 expression with poor outcome to placebo (PBO) + FUL but not TAS + FUL in SANDPIPER. Cancer Research 2023, 83: 5559-5559. DOI: 10.1158/1538-7445.am2023-5559.
Prognostic and Predictive Value of Immune-Related Gene Expression Signatures vs Tumor-Infiltrating Lymphocytes in Early-Stage ERBB2/HER2-Positive Breast CancerFernandez-Martinez A, Pascual T, Singh B, Nuciforo P, Rashid N, Ballman K, Campbell J, Hoadley K, Spears P, Pare L, Brasó-Maristany F, Chic N, Krop I, Partridge A, Cortés J, Llombart-Cussac A, Prat A, Perou C, Carey L. Prognostic and Predictive Value of Immune-Related Gene Expression Signatures vs Tumor-Infiltrating Lymphocytes in Early-Stage ERBB2/HER2-Positive Breast Cancer. JAMA Oncology 2023, 9: 490-499. PMID: 36602784, PMCID: PMC9857319, DOI: 10.1001/jamaoncol.2022.6288.
ER+, HER2− advanced breast cancer treated with taselisib and fulvestrant: genomic landscape and associated clinical outcomesChen J, Jacot W, Cortés J, Krop I, Dent S, Harbeck N, De Laurentiis M, Diéras V, Im Y, Stout T, Schimmoller F, Savage H, Hutchinson K, Wilson T. ER+, HER2− advanced breast cancer treated with taselisib and fulvestrant: genomic landscape and associated clinical outcomes. Molecular Oncology 2023, 17: 2000-2016. PMID: 36892268, PMCID: PMC10552898, DOI: 10.1002/1878-0261.13416.
Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trialTolaney S, Tarantino P, Graham N, Tayob N, Parè L, Villacampa G, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo J, Weiss J, Wagle N, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. The Lancet Oncology 2023, 24: 273-285. PMID: 36858723, DOI: 10.1016/s1470-2045(23)00051-7.
Abstract P1-04-05: Independent validation of the HER2DX genomic test in HER2-positive breast cancer treated with neoadjuvant paclitaxel, trastuzumab and pertuzumab (THP): a correlative analysis from the DAPHNe phase II clinical trialWaks A, Ogayo E, Paré L, Marín-Aguilera M, Brasó-Maristany F, Galván P, Castillo O, Martínez-Sáez O, Vivancos A, Villagrasa P, Tarantino P, Desai N, Guerriero J, Metzger O, Tung N, Krop I, Parker J, Perou C, Prat A, Winer E, Tolaney S, Mittendorf E. Abstract P1-04-05: Independent validation of the HER2DX genomic test in HER2-positive breast cancer treated with neoadjuvant paclitaxel, trastuzumab and pertuzumab (THP): a correlative analysis from the DAPHNe phase II clinical trial. Cancer Research 2023, 83: p1-04-05-p1-04-05. DOI: 10.1158/1538-7445.sabcs22-p1-04-05.
Abstract PD18-02: Adjuvant Paclitaxel and Trastuzumab Trial (APT) for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive (HER2+) Breast Cancer: final 10-year analysisTolaney S, Tarantino P, Graham N, Tayob N, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, DeMeo M, DiLullo M, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Abstract PD18-02: Adjuvant Paclitaxel and Trastuzumab Trial (APT) for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive (HER2+) Breast Cancer: final 10-year analysis. Cancer Research 2023, 83: pd18-02-pd18-02. DOI: 10.1158/1538-7445.sabcs22-pd18-02.
Abstract P1-11-01: Trastuzumab deruxtecan vs treatment of physician’s choice in patients with HER2-low unresectable and/or metastatic breast cancer: Subgroup analyses from DESTINY-Breast04Harbeck N, Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tsurutani J, Ueno N, Prat A, Niikura N, Xu B, Rugo H, Papazisis K, Cortés J, Krop I, Gambhire D, Yung L, Wang Y, Singh J, Cameron D. Abstract P1-11-01: Trastuzumab deruxtecan vs treatment of physician’s choice in patients with HER2-low unresectable and/or metastatic breast cancer: Subgroup analyses from DESTINY-Breast04. Cancer Research 2023, 83: p1-11-01-p1-11-01. DOI: 10.1158/1538-7445.sabcs22-p1-11-01.
Abstract P6-10-03: Datopotamab Deruxtecan (Dato-DXd) in Advanced Triple-Negative Breast Cancer (TNBC): Updated Results From the Phase 1 TROPION-PanTumor01 StudyBardia A, Krop I, Meric-Bernstam F, Tolcher A, Mukohara T, Lisberg A, Shimizu T, Hamilton E, Spira A, Papadopoulos K, Greenberg J, Gu W, Kobayashi F, Zebger-Gong H, Kawasaki Y, Wong R, Kogawa T. Abstract P6-10-03: Datopotamab Deruxtecan (Dato-DXd) in Advanced Triple-Negative Breast Cancer (TNBC): Updated Results From the Phase 1 TROPION-PanTumor01 Study. Cancer Research 2023, 83: p6-10-03-p6-10-03. DOI: 10.1158/1538-7445.sabcs22-p6-10-03.
Abstract PD13-08: PD13-08 Phase 1 TROPION-PanTumor01 Study Evaluating Datopotamab Deruxtecan (Dato-DXd) in Unresectable or Metastatic Hormone Receptor–Positive/HER2–Negative Breast Cancer (BC)Meric-Bernstam F, Krop I, Juric D, Kogawa T, Hamilton E, Spira A, Mukohara T, Tsunoda T, Damodaran S, Greenberg J, Gu W, Kobayashi F, Zebger-Gong H, Kawasaki Y, Wong R, Bardia A. Abstract PD13-08: PD13-08 Phase 1 TROPION-PanTumor01 Study Evaluating Datopotamab Deruxtecan (Dato-DXd) in Unresectable or Metastatic Hormone Receptor–Positive/HER2–Negative Breast Cancer (BC). Cancer Research 2023, 83: pd13-08-pd13-08. DOI: 10.1158/1538-7445.sabcs22-pd13-08.
Abstract GS2-01: GS2-01 Trastuzumab deruxtecan vs physician’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized, phase 3 study DESTINY-Breast02Krop I, Park Y, Kim S, Borges G, Aksoy S, Gregori J, Roylance R, Lim E, Yerushalmi R, Zagouri F, Duhoux F, Fehm T, Takano T, Egorov A, Wu I, Cathcart J, Chu C, Andre F. Abstract GS2-01: GS2-01 Trastuzumab deruxtecan vs physician’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized, phase 3 study DESTINY-Breast02. Cancer Research 2023, 83: gs2-01-gs2-01. DOI: 10.1158/1538-7445.sabcs22-gs2-01.
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain MetastasesLin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases. JAMA Oncology 2023, 9: 197-205. PMID: 36454580, PMCID: PMC9716438, DOI: 10.1001/jamaoncol.2022.5610.
Multiomics in primary and metastatic breast tumors from the AURORA US network finds microenvironment and epigenetic drivers of metastasisGarcia-Recio S, Hinoue T, Wheeler G, Kelly B, Garrido-Castro A, Pascual T, De Cubas A, Xia Y, Felsheim B, McClure M, Rajkovic A, Karaesmen E, Smith M, Fan C, Ericsson P, Sanders M, Creighton C, Bowen J, Leraas K, Burns R, Coppens S, Wheless A, Rezk S, Garrett A, Parker J, Foy K, Shen H, Park B, Krop I, Anders C, Gastier-Foster J, Rimawi M, Nanda R, Lin N, Isaacs C, Marcom P, Storniolo A, Couch F, Chandran U, Davis M, Silverstein J, Ropelewski A, Liu M, Hilsenbeck S, Norton L, Richardson A, Symmans W, Wolff A, Davidson N, Carey L, Lee A, Balko J, Hoadley K, Laird P, Mardis E, King T, Perou C. Multiomics in primary and metastatic breast tumors from the AURORA US network finds microenvironment and epigenetic drivers of metastasis. Nature Cancer 2022, 4: 128-147. PMID: 36585450, PMCID: PMC9886551, DOI: 10.1038/s43018-022-00491-x.
Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]. Annals Of Oncology 2022, 34: 630. PMID: 36564285, DOI: 10.1016/j.annonc.2022.12.005.
Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)Sella T, Zheng Y, Tayob N, Ruddy K, Freedman R, Dang C, Yardley D, Isakoff S, Valero V, DeMeo M, Burstein H, Winer E, Wolff A, Krop I, Partridge A, Tolaney S. Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT). Npj Breast Cancer 2022, 8: 127. PMID: 36450763, PMCID: PMC9712612, DOI: 10.1038/s41523-022-00495-x.
Trastuzumab Deruxtecan in HER2-Positive Metastatic Breast Cancer Patients with Brain Metastases: A DESTINY-Breast01 Subgroup AnalysisJerusalem G, Park YH, Yamashita T, Hurvitz S, Modi S, Andre F, Krop I, Farré X, You B, Saura C, Kim S, Osborne C, Murthy R, Gianni L, Takano T, Liu Y, Cathcart J, Lee C, Perrin C. Trastuzumab Deruxtecan in HER2-Positive Metastatic Breast Cancer Patients with Brain Metastases: A DESTINY-Breast01 Subgroup Analysis. Cancer Discovery 2022, 12: 2754-2762. PMID: 36255231, PMCID: PMC9716244, DOI: 10.1158/2159-8290.cd-22-0837.
Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancerWaks AG, Keenan TE, Li T, Tayob N, Wulf GM, Richardson ET, Attaya V, Anderson L, Mittendorf EA, Overmoyer B, Winer EP, Krop IE, Agudo J, Van Allen EM, Tolaney SM. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Journal For ImmunoTherapy Of Cancer 2022, 10: e005119. PMID: 36252998, PMCID: PMC9577940, DOI: 10.1136/jitc-2022-005119.
Clinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer.Tsuji J, Li T, Grinshpun A, Coorens T, Russo D, Anderson L, Rees R, Nardone A, Patterson C, Lennon NJ, Cibulskis C, Leshchiner I, Tayob N, Tolaney SM, Tung N, McDonnell DP, Krop IE, Winer EP, Stewart C, Getz G, Jeselsohn R. Clinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer. Clinical Cancer Research 2022, 28: 5066-5078. PMID: 36215125, PMCID: PMC9722539, DOI: 10.1158/1078-0432.ccr-22-2305.
191P Correlation of early change in standardized uptake value (SUV) on positron emission tomography (PET/CT) with recurrence-free survival (RFS) and overall survival (OS) in patients with primary operable HER2-positive breast cancer (TBCRC026)Hennessy M, Leal J, Huang C, Solnes L, Denbow R, Abramson V, Carey L, Liu M, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Cimino-Mathews A, Wahl R, Stearns V, Connolly R. 191P Correlation of early change in standardized uptake value (SUV) on positron emission tomography (PET/CT) with recurrence-free survival (RFS) and overall survival (OS) in patients with primary operable HER2-positive breast cancer (TBCRC026). Annals Of Oncology 2022, 33: s623-s624. DOI: 10.1016/j.annonc.2022.07.226.
Nodal Positivity in Early-Stage Triple-Negative Breast Cancer: Implications for Preoperative ImmunotherapyMittendorf EA, Kantor O, Weiss A, Richardson E, Garrido-Castro A, Portnow LH, Krop IE, Lin NU, Winer EP, Tolaney SM, King TA. Nodal Positivity in Early-Stage Triple-Negative Breast Cancer: Implications for Preoperative Immunotherapy. Annals Of Surgical Oncology 2022, 30: 100-106. PMID: 35941343, DOI: 10.1245/s10434-022-12357-8.
Abstract 5165: The genomic landscape and prognostic implications of somatic alterations in patients (pts) with ER+, HER2-, PIK3CA mutated (mut) advanced breast cancer treated with taselisib and fulvestrantChen J, Dent S, Jacot W, Cortés J, Krop I, Stout T, Schimmoller F, Savage H, Hutchinson K, Wilson T. Abstract 5165: The genomic landscape and prognostic implications of somatic alterations in patients (pts) with ER+, HER2-, PIK3CA mutated (mut) advanced breast cancer treated with taselisib and fulvestrant. Cancer Research 2022, 82: 5165-5165. DOI: 10.1158/1538-7445.am2022-5165.
Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast CancerLipsyc-Sharf M, de Bruin EC, Santos K, McEwen R, Stetson D, Patel A, Kirkner GJ, Hughes ME, Tolaney SM, Partridge AH, Krop IE, Knape C, Feger U, Marsico G, Howarth K, Winer EP, Lin NU, Parsons HA. Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 2408-2419. PMID: 35658506, PMCID: PMC9467679, DOI: 10.1200/jco.22.00908.
Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP).Lipsyc-Sharf M, De Bruin E, Santos K, McEwen R, Stetson D, Patel A, Kirkner G, Hughes M, Tolaney S, Krop I, Knape C, Feger U, Marsico G, Howarth K, Winer E, Lin N, Parsons H. Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP). Journal Of Clinical Oncology 2022, 40: 103-103. DOI: 10.1200/jco.2022.40.16_suppl.103.
Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC).Krop I, Masuda N, Mukohara T, Takahashi S, Nakayama T, Inoue K, Iwata H, Toyama T, Yamamoto Y, Hansra D, Takahashi M, Osaki A, Koyama K, Inoue T, Yonekura T, Mostillo J, Ohwada S, Tanaka Y, Sternberg D, Yonemori K. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC). Journal Of Clinical Oncology 2022, 40: 1002-1002. DOI: 10.1200/jco.2022.40.16_suppl.1002.
Long-term safety of inavolisib (GDC-0077) in an ongoing phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib and/or endocrine therapy in patients (pts) with PIK3CA -mutated, hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (BC).Bedard P, Accordino M, Cervantes A, Gambardella V, Hamilton E, Italiano A, Juric D, Kalinsky K, Krop I, Oliveira M, Saura C, Schmid P, Turner N, Varga A, Shankar N, Schutzman J, Royer-Joo S, Martin M, Jhaveri K. Long-term safety of inavolisib (GDC-0077) in an ongoing phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib and/or endocrine therapy in patients (pts) with PIK3CA -mutated, hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (BC). Journal Of Clinical Oncology 2022, 40: 1052-1052. DOI: 10.1200/jco.2022.40.16_suppl.1052.
Clinical outcomes with alpelisib (ALP) plus fulvestrant (FUL) after prior treatment (tx) with FUL in patients (pts) with advanced breast cancer (ABC): A real-world (RW) analysis.O'Shaughnessy J, Woeckel A, Pistilli B, Hegg R, Vahdat L, Vuina D, Asad ZVK P, Smith T, Kim J, Krop I. Clinical outcomes with alpelisib (ALP) plus fulvestrant (FUL) after prior treatment (tx) with FUL in patients (pts) with advanced breast cancer (ABC): A real-world (RW) analysis. Journal Of Clinical Oncology 2022, 40: 1055-1055. DOI: 10.1200/jco.2022.40.16_suppl.1055.
Longitudinal circulating tumor DNA (ctDNA) whole-exome sequencing (WES) in the phase Ib/II trial of palbociclib and bazedoxifene reveals genomic dynamics and clonal evolution with the acquisition of treatment resistance in hormone receptor-positive, HER2-negative (HR+ HER2-), advanced breast cancer (ABC).Grinshpun A, Tsuji J, Li T, Russo D, Anderson L, Rees R, Cibulskis C, Leshchiner I, Stewart C, Tung N, Krop I, Winer E, Tolaney S, Getz G, Jeselsohn R. Longitudinal circulating tumor DNA (ctDNA) whole-exome sequencing (WES) in the phase Ib/II trial of palbociclib and bazedoxifene reveals genomic dynamics and clonal evolution with the acquisition of treatment resistance in hormone receptor-positive, HER2-negative (HR+ HER2-), advanced breast cancer (ABC). Journal Of Clinical Oncology 2022, 40: 1058-1058. DOI: 10.1200/jco.2022.40.16_suppl.1058.
Phase 2 trial of tucatinib plus trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (HER2CLIMB-04, trial in progress).Krop I, Carey L, Ramos J, Chen Y, Hamilton E. Phase 2 trial of tucatinib plus trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (HER2CLIMB-04, trial in progress). Journal Of Clinical Oncology 2022, 40: tps1111-tps1111. DOI: 10.1200/jco.2022.40.16_suppl.tps1111.
Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline UpdateGiordano SH, Franzoi MAB, Temin S, Anders CK, Chandarlapaty S, Crews JR, Kirshner JJ, Krop IE, Lin NU, Morikawa A, Patt DA, Perlmutter J, Ramakrishna N, Davidson NE. Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update. Journal Of Clinical Oncology 2022, 40: 2612-2635. PMID: 35640077, DOI: 10.1200/jco.22.00519.
Management of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Guideline UpdateRamakrishna N, Anders CK, Lin NU, Morikawa A, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Franzoi MAB, Kirshner JJ, Krop IE, Patt DA, Perlmutter J, Giordano SH. Management of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Guideline Update. Journal Of Clinical Oncology 2022, 40: 2636-2655. PMID: 35640075, DOI: 10.1200/jco.22.00520.
A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancerWaks AG, Desai NV, Li T, Poorvu PD, Partridge AH, Sinclair N, Spring LM, Faggen M, Constantine M, Metzger O, Alberti J, Deane J, Rosenberg SM, Frank E, Tolaney SM, Krop IE, Tung NM, Tayob N, King TA, Mittendorf EA, Winer EP. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. Npj Breast Cancer 2022, 8: 63. PMID: 35538105, PMCID: PMC9091255, DOI: 10.1038/s41523-022-00429-7.
175P Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Subgroup analyses from the BYLieve studyCardoso F, Juric D, Lerebours F, Krop I, Borrego M, Neven P, Park Y, Yardley D, Jhaveri K, Arce C, Gu E, Akdere M, Rugo H. 175P Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Subgroup analyses from the BYLieve study. Annals Of Oncology 2022, 33: s206-s207. DOI: 10.1016/j.annonc.2022.03.194.
Aktualisierte Ergebnisse von Tucatinib versus Placebo in Kombination mit Trastuzumab und Capecitabin bei Patienten mit vorbehandeltem, metastasierten HER2-positiven Brustkrebs mit ZNS-Metastasen (HER2CLIMB)Greil R, Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Aktualisierte Ergebnisse von Tucatinib versus Placebo in Kombination mit Trastuzumab und Capecitabin bei Patienten mit vorbehandeltem, metastasierten HER2-positiven Brustkrebs mit ZNS-Metastasen (HER2CLIMB). Geburtshilfe Und Frauenheilkunde 2022, 82: e4-e5. DOI: 10.1055/s-0042-1746156.
Aiming at a Tailored Cure for ERBB2-Positive Metastatic Breast CancerTarantino P, Curigliano G, Parsons HA, Lin NU, Krop I, Mittendorf EA, Waks A, Winer EP, Tolaney SM. Aiming at a Tailored Cure for ERBB2-Positive Metastatic Breast Cancer. JAMA Oncology 2022, 8: 629-635. PMID: 35024766, DOI: 10.1001/jamaoncol.2021.6597.
Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trialGelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M, Committee and Investigators A. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. European Journal Of Cancer 2022, 166: 219-228. PMID: 35313167, DOI: 10.1016/j.ejca.2022.01.031.
Massively parallel enrichment of low-frequency alleles enables duplex sequencing at low depthGydush G, Nguyen E, Bae JH, Blewett T, Rhoades J, Reed SC, Shea D, Xiong K, Liu R, Yu F, Leong KW, Choudhury AD, Stover DG, Tolaney SM, Krop IE, Christopher Love J, Parsons HA, Mike Makrigiorgos G, Golub TR, Adalsteinsson VA. Massively parallel enrichment of low-frequency alleles enables duplex sequencing at low depth. Nature Biomedical Engineering 2022, 6: 257-266. PMID: 35301450, PMCID: PMC9089460, DOI: 10.1038/s41551-022-00855-9.
Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trialBarroso-Sousa R, Tarantino P, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy KJ, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I, Tolaney SM. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. Npj Breast Cancer 2022, 8: 18. PMID: 35173164, PMCID: PMC8850608, DOI: 10.1038/s41523-022-00385-2.
Abstract P2-07-03: Correlation of immune-related protein expression with hormone receptor (HR) status and pathologic response to neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) among patients with early-stage HER2+ breast cancerWaks A, Huang Y, Hether T, Ogayo E, Kadel S, Alberti J, Tolaney S, Krop I, Divakar P, Metzger O, O'Donnell M, Church S, Winer E, Guerriero J, Mittendorf E. Abstract P2-07-03: Correlation of immune-related protein expression with hormone receptor (HR) status and pathologic response to neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) among patients with early-stage HER2+ breast cancer. Cancer Research 2022, 82: p2-07-03-p2-07-03. DOI: 10.1158/1538-7445.sabcs21-p2-07-03.
Abstract P5-13-15: High dimensional flow cytometric analysis or the peripheral immune profile and response to HER2-targeted antibody therapyOgayo E, Waks A, Rogers W, Ionita M, Adigwe K, Alberti J, Kadel S, Moore J, King T, Krop I, Tolaney S, Winer E, Guerriero J, Mittendorf E. Abstract P5-13-15: High dimensional flow cytometric analysis or the peripheral immune profile and response to HER2-targeted antibody therapy. Cancer Research 2022, 82: p5-13-15-p5-13-15. DOI: 10.1158/1538-7445.sabcs21-p5-13-15.
Abstract PD4-04: Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2-positive metastatic breast cancer with brain metastases (HER2CLIMB)Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Abstract PD4-04: Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2-positive metastatic breast cancer with brain metastases (HER2CLIMB). Cancer Research 2022, 82: pd4-04-pd4-04. DOI: 10.1158/1538-7445.sabcs21-pd4-04.
Abstract GS1-05: Datopotamab deruxtecan in advanced/metastatic HER2- breast cancer: Results from the phase 1 TROPION-PanTumor01 studyKrop I, Juric D, Shimizu T, Tolcher A, Spira A, Mukohara T, Lisberg A, Kogawa T, Papadopoulos K, Hamilton E, Damodaran S, Greenberg J, Gu W, Kobayashi F, Guevara F, Jikoh T, Kawasaki Y, Meric-Bernstam F, Bardia A. Abstract GS1-05: Datopotamab deruxtecan in advanced/metastatic HER2- breast cancer: Results from the phase 1 TROPION-PanTumor01 study. Cancer Research 2022, 82: gs1-05-gs1-05. DOI: 10.1158/1538-7445.sabcs21-gs1-05.
Abstract OT1-13-01: HER2CLIMB-04: phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (trial in progress)Hamilton E, Carey L, Ramos J, Chen Y, Krop I. Abstract OT1-13-01: HER2CLIMB-04: phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (trial in progress). Cancer Research 2022, 82: ot1-13-01-ot1-13-01. DOI: 10.1158/1538-7445.sabcs21-ot1-13-01.
Abstract P2-12-18: A phase 2 study of neoadjuvant systemic therapy with eribulin followed by doxorubicin and cyclophosphamide for HER2-negative inflammatory breast cancerLynce F, Yeh E, Regan M, Qin L, Bay C, Krop I, Harrison B, Nakhlis F, Bellon J, Overmoyer B. Abstract P2-12-18: A phase 2 study of neoadjuvant systemic therapy with eribulin followed by doxorubicin and cyclophosphamide for HER2-negative inflammatory breast cancer. Cancer Research 2022, 82: p2-12-18-p2-12-18. DOI: 10.1158/1538-7445.sabcs21-p2-12-18.
Abstract P2-13-25: A phase I dose-escalation study of DHES0815A, a HER2-targeting antibody-drug conjugate with a DNA monoalkylator payload, in patients with HER2-positive breast cancerKrop I, Hamilton E, Jung K, Modi S, Kalinsky K, Phillips G, Shi R, Monemi S, Mamounas M, Saad O, Choeurng V, Commerford R, Cho E, Ungewickell A, LoRusso P. Abstract P2-13-25: A phase I dose-escalation study of DHES0815A, a HER2-targeting antibody-drug conjugate with a DNA monoalkylator payload, in patients with HER2-positive breast cancer. Cancer Research 2022, 82: p2-13-25-p2-13-25. DOI: 10.1158/1538-7445.sabcs21-p2-13-25.
Abstract P5-17-05: A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA -mutated hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancerJuric D, Bedard P, Cervantes A, Gambardella V, Oliveira M, Saura C, Kalinsky K, Hamilton E, Italiano A, Krop I, Schmid P, Turner N, Varga A, Royer-Joo S, Hutchinson K, Schutzman J, Jhaveri K. Abstract P5-17-05: A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA -mutated hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer. Cancer Research 2022, 82: p5-17-05-p5-17-05. DOI: 10.1158/1538-7445.sabcs21-p5-17-05.
Abstract PD4-02: Safety and efficacy of a tucatinib-trastuzumab-capecitabine regimen for treatment of leptomeningeal metastasis (LM) in HER2-positive breast cancer: Results from TBCRC049, a phase 2 non-randomized studyMurthy R, O'Brien B, Berry D, Singareeka-Raghavendra A, Monroe M, Johnson J, White J, Childress J, Sanford J, Schwartz-Gomez J, Melisko M, Morikawa A, Ferguson S, de Groot J, Krop I, Valero V, Rimawi M, Wolff A, Tripathy D, Lin N, Stringer-Reasor E. Abstract PD4-02: Safety and efficacy of a tucatinib-trastuzumab-capecitabine regimen for treatment of leptomeningeal metastasis (LM) in HER2-positive breast cancer: Results from TBCRC049, a phase 2 non-randomized study. Cancer Research 2022, 82: pd4-02-pd4-02. DOI: 10.1158/1538-7445.sabcs21-pd4-02.
Phase II Study of Taselisib in PIK3CA-Mutated Solid Tumors Other Than Breast and Squamous Lung Cancer: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol IKrop IE, Jegede OA, Grilley-Olson JE, Lauring JD, Mitchell EP, Zwiebel JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Kono SA, Ford JM, Garcia AA, Sui XD, Siegel RD, Slomovitz BM, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Taselisib in PIK3CA-Mutated Solid Tumors Other Than Breast and Squamous Lung Cancer: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol I. JCO Precision Oncology 2022, 6: e2100424. PMID: 35138919, PMCID: PMC8865530, DOI: 10.1200/po.21.00424.
Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033): A Phase II Randomized Trial of Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab in Women With Stage I HER2-Positive Breast CancerBellon JR, Tayob N, Yang DD, Tralins J, Dang CT, Isakoff SJ, DeMeo M, Burstein HJ, Partridge AH, Winer EP, Krop IE, Tolaney SM. Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033): A Phase II Randomized Trial of Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab in Women With Stage I HER2-Positive Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2022, 113: 117-124. PMID: 34990776, DOI: 10.1016/j.ijrobp.2021.12.173.
Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysisCurigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis. Annals Of Oncology 2021, 33: 321-329. PMID: 34954044, DOI: 10.1016/j.annonc.2021.12.005.
Should Ki-67 be adopted to select breast cancer patients for treatment with adjuvant abemaciclib?Tarantino P, Burstein H, Lin N, Krop I, Winer E, Schnitt S, Hamilton E, Hurvitz S, Rugo H, Curigliano G, Tolaney S. Should Ki-67 be adopted to select breast cancer patients for treatment with adjuvant abemaciclib? Annals Of Oncology 2021, 33: 234-238. PMID: 34942341, DOI: 10.1016/j.annonc.2021.12.004.
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN StudyKrop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study. Journal Of Clinical Oncology 2021, 40: 438-448. PMID: 34890214, PMCID: PMC8824393, DOI: 10.1200/jco.21.00896.
Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033), a Phase II Randomized Trial of Adjuvant T-DM1 vs. TH in Women With Stage I HER2 Positive Breast CancerBellon J, Tayob N, Burstein H, Partridge A, Demeo M, Tralins J, Yang D, Dang C, Isakoff S, Yardley D, Valero V, Winer E, Krop I, Tolaney S. Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033), a Phase II Randomized Trial of Adjuvant T-DM1 vs. TH in Women With Stage I HER2 Positive Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: s34. DOI: 10.1016/j.ijrobp.2021.07.103.
Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancerO'Sullivan CC, Ballman KV, McCall L, Kommalapati A, Zemla T, Weiss A, Mitchell M, Blinder V, Tung NM, Irvin WJ, Lee M, Goetz MP, Symmans WF, Borges VF, Krop I, Carey LA, Partridge AH. Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Future Oncology 2021, 17: 4665-4676. PMID: 34636255, PMCID: PMC8600597, DOI: 10.2217/fon-2021-0753.
Molecular correlates of response to eribulin and pembrolizumab in hormone receptor-positive metastatic breast cancerKeenan TE, Guerriero JL, Barroso-Sousa R, Li T, O’Meara T, Giobbie-Hurder A, Tayob N, Hu J, Severgnini M, Agudo J, Vaz-Luis I, Anderson L, Attaya V, Park J, Conway J, He MX, Reardon B, Shannon E, Wulf G, Spring LM, Jeselsohn R, Krop I, Lin NU, Partridge A, Winer EP, Mittendorf EA, Liu D, Van Allen EM, Tolaney SM. Molecular correlates of response to eribulin and pembrolizumab in hormone receptor-positive metastatic breast cancer. Nature Communications 2021, 12: 5563. PMID: 34548479, PMCID: PMC8455578, DOI: 10.1038/s41467-021-25769-z.
Reply to M. Tanaka et alTolaney SM, Partridge AH, Winer EP, Krop IE. Reply to M. Tanaka et al. Journal Of Clinical Oncology 2021, 39: 3648-3649. PMID: 34506210, DOI: 10.1200/jco.21.01967.
259P Weekly ladiratuzumab vedotin monotherapy for metastatic triple-negative breast cancerTsai M, Han H, Montero A, Tkaczuk K, Assad H, Pusztai L, Hurvitz S, Wilks S, Specht J, Nanda R, Mita M, O'Shaughnessy J, Krop I, Medgyesy D, Abraham J, Modi S, Li H, Wu S, Garfin P, Burris H. 259P Weekly ladiratuzumab vedotin monotherapy for metastatic triple-negative breast cancer. Annals Of Oncology 2021, 32: s474-s475. DOI: 10.1016/j.annonc.2021.08.542.
120MO Prognostic value of immune gene-expression signatures (iGES) vs tumor-infiltrating lymphocytes (TILs) in early-stage HER2+ breast cancer: A combined analysis of CALGB 40601 (C40601) and PAMELA trialsFernandez-Martinez A, Pascual T, Singh B, Nuciforo P, Hoadley K, Rashid N, Spears P, Chic N, Krop I, Hillman D, Partridge A, Prat A, Carey L, Perou C. 120MO Prognostic value of immune gene-expression signatures (iGES) vs tumor-infiltrating lymphocytes (TILs) in early-stage HER2+ breast cancer: A combined analysis of CALGB 40601 (C40601) and PAMELA trials. Annals Of Oncology 2021, 32: s409. DOI: 10.1016/j.annonc.2021.08.401.
279P Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive metastatic breast cancer (MBC): Updated survival results from a phase II trial (DESTINY-Breast01)Manich C, Modi S, Krop I, Park Y, Kim S, Tamura K, André F, Iwata H, Ito Y, Tsurutani J, Sohn J, Lee C, Liu Y, Cathcart J, Singh J, Yamashita T. 279P Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive metastatic breast cancer (MBC): Updated survival results from a phase II trial (DESTINY-Breast01). Annals Of Oncology 2021, 32: s485-s486. DOI: 10.1016/j.annonc.2021.08.562.
331TiP HER2CLIMB-04: Phase II trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastasesCarey L, Krop I, Ramos J, Feng W, Hamilton E. 331TiP HER2CLIMB-04: Phase II trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases. Annals Of Oncology 2021, 32: s510-s511. DOI: 10.1016/j.annonc.2021.08.614.
A phase II study of efficacy, toxicity, and the potential impact of genomic alterations on response to eribulin mesylate in combination with trastuzumab and pertuzumab in women with human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancerBalch SM, Vaz-Luis I, Li T, Tayob N, Jain E, Helvie K, Buendia-Buendia JE, Shannon E, Isakoff SJ, Tung NM, Krop IE, Lin NU, Wagle N, Freedman RA. A phase II study of efficacy, toxicity, and the potential impact of genomic alterations on response to eribulin mesylate in combination with trastuzumab and pertuzumab in women with human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancer. Breast Cancer Research And Treatment 2021, 189: 411-423. PMID: 34302589, DOI: 10.1007/s10549-021-06329-x.
Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)Ruddy KJ, Zheng Y, Tayob N, Hu J, Dang CT, Yardley DA, Isakoff SJ, Valero VV, Faggen MG, Mulvey TM, Bose R, Sella T, Weckstein DJ, Wolff AC, Reeder-Hayes KE, Rugo HS, Ramaswamy B, Zuckerman DS, Hart LL, Gadi VK, Constantine M, Cheng KL, Briccetti FM, Schneider BP, Merrill Garrett A, Kelly Marcom P, Albain KS, DeFusco PA, Tung NM, Ardman BM, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Rosenberg S, DeMeo MK, Burstein HJ, Winer EP, Krop IE, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial). Breast Cancer Research And Treatment 2021, 189: 103-110. PMID: 34120223, DOI: 10.1007/s10549-021-06267-8.
Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patientsPaoletti C, Regan MM, Niman SM, Dolce EM, Darga EP, Liu MC, Marcom PK, Hart LL, Smith JW, Tedesco KL, Amir E, Krop IE, DeMichele AM, Goodwin PJ, Block M, Aung K, Brown ME, McCormack RT, Hayes DF. Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients. Npj Breast Cancer 2021, 7: 77. PMID: 34117261, PMCID: PMC8196036, DOI: 10.1038/s41523-021-00281-1.
Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical TrialTolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.
A phase I/Ib study evaluating GDC-0077 (inavolisib) + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)Schmid P, Bedard P, Jhaveri K, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Saura C, Turner N, Varga A, Hutchinson K, Lei G, Royer-Joo S, Thomas P, JL S, Juric D. A phase I/Ib study evaluating GDC-0077 (inavolisib) + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC). Senologie - Zeitschrift Für Mammadiagnostik Und -therapie 2021, 18: e36-e37. DOI: 10.1055/s-0041-1730220.
Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB).Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Zhang C, Winer E. Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2021, 39: 1043-1043. DOI: 10.1200/jco.2021.39.15_suppl.1043.
Pharmacokinetic (PK) analyses in CSF and plasma from TBCRC049, an ongoing trial to assess the safety and efficacy of the combination of tucatinib, trastuzumab and capecitabine for the treatment of leptomeningeal metastasis (LM) in HER2 positive breast cancer.Stringer-Reasor E, O'Brien B, Topletz-Erickson A, White J, Lobbous M, Riley K, Childress J, LaMaster K, Melisko M, Morikawa A, De Groot J, Krop I, Valero V, Rimawi M, Wolff A, Tripathy D, Lin N, Murthy R. Pharmacokinetic (PK) analyses in CSF and plasma from TBCRC049, an ongoing trial to assess the safety and efficacy of the combination of tucatinib, trastuzumab and capecitabine for the treatment of leptomeningeal metastasis (LM) in HER2 positive breast cancer. Journal Of Clinical Oncology 2021, 39: 1044-1044. DOI: 10.1200/jco.2021.39.15_suppl.1044.
Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: A subgroup analysis of the DESTINY-Breast01 trial.Jerusalem G, Park Y, Yamashita T, Hurvitz S, Modi S, Andre F, Krop I, Gonzalez X, Hall P, You B, Saura C, Kim S, Osborne C, Sagara Y, Tokunaga E, Liu Y, Cathcart J, Lee C, Perrin C. Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: A subgroup analysis of the DESTINY-Breast01 trial. Journal Of Clinical Oncology 2021, 39: 526-526. DOI: 10.1200/jco.2021.39.15_suppl.526.
HER2CLIMB-04: Phase 2 open label trial of tucatinib plus trastuzumab deruxtecan in patients with HER2+ unresectable locally advanced or metastatic breast cancer with and without brain metastases (trial in progress).Krop I, Ramos J, Zhang C, Hamilton E. HER2CLIMB-04: Phase 2 open label trial of tucatinib plus trastuzumab deruxtecan in patients with HER2+ unresectable locally advanced or metastatic breast cancer with and without brain metastases (trial in progress). Journal Of Clinical Oncology 2021, 39: tps1097-tps1097. DOI: 10.1200/jco.2021.39.15_suppl.tps1097.
Trial in progress: A phase 1b/2 study of the PARP inhibitor niraparib in combination with trastuzumab in patients with metastatic HER2+ breast cancer (TBCRC 050).Stringer-Reasor E, Li Y, Witherspoon F, Specht J, Del Santo Anampa Mesias J, Nanda R, Dees E, Wolff A, Krop I, Lin N, Rimawi M, Yang E. Trial in progress: A phase 1b/2 study of the PARP inhibitor niraparib in combination with trastuzumab in patients with metastatic HER2+ breast cancer (TBCRC 050). Journal Of Clinical Oncology 2021, 39: tps1098-tps1098. DOI: 10.1200/jco.2021.39.15_suppl.tps1098.
A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer.O'Sullivan C, Ballman K, McCall L, Zemla T, Weiss A, Mitchell M, Blinder V, Tung N, Irvin W, Lee M, Goetz M, Symmans W, Borges V, Krop I, Partridge A, Carey L. A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Journal Of Clinical Oncology 2021, 39: tps595-tps595. DOI: 10.1200/jco.2021.39.15_suppl.tps595.
Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor CellsParsons HA, Macrae ER, Guo H, Li T, Barry WT, Tayob N, Wulf GM, Isakoff SJ, Krop IE. Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells. JCO Precision Oncology 2021, 5: 896-903. PMID: 34994617, PMCID: PMC9848583, DOI: 10.1200/po.20.00461.
Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast CancerConnolly RM, Leal JP, Solnes L, Huang CY, Carpenter A, Gaffney K, Abramson V, Carey LA, Liu MC, Rimawi M, Specht J, Storniolo AM, Valero V, Vaklavas C, Krop IE, Winer EP, Camp M, Miller RS, Wolff AC, Cimino-Mathews A, Park BH, Wahl RL, Stearns V. Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. Journal Of Clinical Oncology 2021, 39: 2247-2256. PMID: 33999652, PMCID: PMC8260904, DOI: 10.1200/jco.21.00280.
FOXA1 and adaptive response determinants to HER2 targeted therapy in TBCRC 036Angus SP, Stuhlmiller TJ, Mehta G, Bevill SM, Goulet DR, Olivares-Quintero JF, East MP, Tanioka M, Zawistowski JS, Singh D, Sciaky N, Chen X, He X, Rashid NU, Chollet-Hinton L, Fan C, Soloway MG, Spears PA, Jefferys S, Parker JS, Gallagher KK, Forero-Torres A, Krop IE, Thompson AM, Murthy R, Gatza ML, Perou CM, Earp HS, Carey LA, Johnson GL. FOXA1 and adaptive response determinants to HER2 targeted therapy in TBCRC 036. Npj Breast Cancer 2021, 7: 51. PMID: 33980863, PMCID: PMC8115531, DOI: 10.1038/s41523-021-00258-0.
Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumabFilho OM, Viale G, Stein S, Trippa L, Yardley DA, Mayer IA, Abramson VG, Arteaga CL, Spring LM, Waks AG, Wrabel E, DeMeo MK, Bardia A, Dell'Orto P, Russo L, King TA, Polyak K, Michor F, Winer EP, Krop IE. Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab. Cancer Discovery 2021, 11: candisc.1557.2020. PMID: 33941592, PMCID: PMC8598376, DOI: 10.1158/2159-8290.cd-20-1557.
42O Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) plus taxane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC)Metzger O, Lambertini C, Krop I, Phillips G, Perou C, Symmans F, Melero I, Harbeck N, Winer E, Im S, Barrios C, Bonnefoi H, Gralow J, Ellis P, Gianni L, Toi M, Swain S, Boulet T, Song C, de Haas S. 42O Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) plus taxane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC). Annals Of Oncology 2021, 32: s37-s38. DOI: 10.1016/j.annonc.2021.03.056.
LBA4 Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate (ADC), for triple-negative breast cancer (TNBC): Preliminary results from an ongoing phase I trialBardia A, Juric D, Shimizu T, Tolcher A, Karim R, Spira A, Mukohara T, Lisberg A, Kogawa T, Krop I, Papadopoulos K, Hamilton E, Damodaran S, Greenberg J, Gu W, Kobayashi F, Guevara F, Jikoh T, Kawasaki Y, Meric-Bernstam F. LBA4 Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate (ADC), for triple-negative breast cancer (TNBC): Preliminary results from an ongoing phase I trial. Annals Of Oncology 2021, 32: s60. DOI: 10.1016/j.annonc.2021.03.213.
128TiP HER2CLIMB-04: Phase II trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ unresectable locally-advanced or metastatic breast cancer with and without brain metastasesHamilton E, Ramos J, Feng W, Krop I. 128TiP HER2CLIMB-04: Phase II trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ unresectable locally-advanced or metastatic breast cancer with and without brain metastases. Annals Of Oncology 2021, 32: s76. DOI: 10.1016/j.annonc.2021.03.142.
The impact of tumor epithelial and microenvironmental heterogeneity on treatment responses in HER2-positive breast cancerJaniszewska M, Stein S, Filho O, Eng J, Kingston NL, Harper NW, Rye IH, Alečković M, Trinh A, Murphy KC, Marangoni E, Cristea S, Oakes B, Winer EP, Krop I, Russnes HG, Spellman PT, Bucher E, Hu Z, Chin K, Gray JW, Michor F, Polyak K. The impact of tumor epithelial and microenvironmental heterogeneity on treatment responses in HER2-positive breast cancer. JCI Insight 2021, 6: e147617. PMID: 33886505, PMCID: PMC8262355, DOI: 10.1172/jci.insight.147617.
The efficacy and safety of enzalutamide with trastuzumab in patients with HER2+ and androgen receptor-positive metastatic or locally advanced breast cancerWardley A, Cortes J, Provencher L, Miller K, Chien AJ, Rugo HS, Steinberg J, Sugg J, Tudor IC, Huizing M, Young R, Abramson V, Bose R, Hart L, Chan S, Cameron D, Wright GS, Graas MP, Neven P, Rocca A, Russo S, Krop IE. The efficacy and safety of enzalutamide with trastuzumab in patients with HER2+ and androgen receptor-positive metastatic or locally advanced breast cancer. Breast Cancer Research And Treatment 2021, 187: 155-165. PMID: 33591468, PMCID: PMC8062601, DOI: 10.1007/s10549-021-06109-7.
Abstract OT-03-06: Phase 2 study of response-guided neoadjuvant sacituzumab govitecan (IMMU-132) in patients with localized triple-negative breast cancer (NeoSTAR)Spring L, Tolaney S, Desai N, Comander A, Mulvey T, Krop I, Winer E, Mittendorf E, Ellisen L, Bardia A. Abstract OT-03-06: Phase 2 study of response-guided neoadjuvant sacituzumab govitecan (IMMU-132) in patients with localized triple-negative breast cancer (NeoSTAR). Cancer Research 2021, 81: ot-03-06-ot-03-06. DOI: 10.1158/1538-7445.sabcs20-ot-03-06.
Abstract PD3-05: The DAPHNE trial: A feasibility study of chemotherapy de-escalation based on response to neoadjuvant paclitaxel-HP (THP) in HER2-positive breast cancerWaks A, Desai N, Li T, Poorvu P, Partridge A, Sinclair N, Spring L, Faggen M, Constantine M, Alberti J, Deane J, Rosenberg S, Tolaney S, Krop I, Tung N, Tayob N, King T, Mittendorf E, Winer E. Abstract PD3-05: The DAPHNE trial: A feasibility study of chemotherapy de-escalation based on response to neoadjuvant paclitaxel-HP (THP) in HER2-positive breast cancer. Cancer Research 2021, 81: pd3-05-pd3-05. DOI: 10.1158/1538-7445.sabcs20-pd3-05.
Abstract OT-03-03: SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancerBeckwith H, Medgyesy D, Abraham J, Nanda R, Tkaczuk K, Krop I, Pusztai L, Modi S, Mita M, Specht J, Hurvitz S, Han H, Kalinsky K, Wilks S, O’Shaughnessy J, Hart L, Rugo H, Mitri Z, Garfin P, Burris H. Abstract OT-03-03: SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer. Cancer Research 2021, 81: ot-03-03-ot-03-03. DOI: 10.1158/1538-7445.sabcs20-ot-03-03.
Abstract PS5-12: Preliminary correlative analysis of clinical outcomes with PIK3CA mutation (mut) status from a phase I/Ib study of GDC-0077 in patients (pts) with hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)Jhaveri K, Juric D, Varga A, Turner N, Schmid P, Saura C, Oliveira M, Krop I, Kalinsky K, Italiano A, Hamilton E, Gambardella V, Cervantes A, Bedard P, Liu B, Chen J, Aimi J, Royer-Joo S, Schutzman J, Hutchinson K. Abstract PS5-12: Preliminary correlative analysis of clinical outcomes with PIK3CA mutation (mut) status from a phase I/Ib study of GDC-0077 in patients (pts) with hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC). Cancer Research 2021, 81: ps5-12-ps5-12. DOI: 10.1158/1538-7445.sabcs20-ps5-12.
Abstract OT-28-03: VICKI: A Phase Ib/II, randomized, placebo-controlled, study of venetoclax plus ado-trastuzumab emtansine (T-DM1) in patients (pts) with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC)Lindeman G, Hamilton E, Krop I, Lim B, Modi S, Saura C, Desai R, Danner B, Fernando T, Kong S, Legrand F, Nasroulah F. Abstract OT-28-03: VICKI: A Phase Ib/II, randomized, placebo-controlled, study of venetoclax plus ado-trastuzumab emtansine (T-DM1) in patients (pts) with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC). Cancer Research 2021, 81: ot-28-03-ot-28-03. DOI: 10.1158/1538-7445.sabcs20-ot-28-03.
Abstract PD1-02: A phase I/Ib study evaluating GDC-0077 + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA -mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)Bedard P, Jhaveri K, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Saura C, Schmid P, Turner N, Varga A, Hutchinson K, Lei G, Royer-Joo S, Thomas P, Schutzman J, Juric D. Abstract PD1-02: A phase I/Ib study evaluating GDC-0077 + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA -mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC). Cancer Research 2021, 81: pd1-02-pd1-02. DOI: 10.1158/1538-7445.sabcs20-pd1-02.
Abstract PD1-09: Safety and efficacy results from the phase 1/2 study of U3-1402, a human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC)Krop I, Yonemori K, Takahashi S, Inoue K, Nakayama T, Iwata H, Toyama T, Yamamoto Y, Takahashi M, Osaki A, Saji S, Sagara Y, O’Shaughnessy J, Traina T, Ohwada S, Qi Z, Qiu Y, Onuma H, Sharma O, Mekan S, Masuda N. Abstract PD1-09: Safety and efficacy results from the phase 1/2 study of U3-1402, a human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC). Cancer Research 2021, 81: pd1-09-pd1-09. DOI: 10.1158/1538-7445.sabcs20-pd1-09.
Abstract PD3-01: BluePrint performance in predicting pertuzumab benefit in genomically HER2-positive patients: A biomarker analysis of the APHINITY trialKrop I, Mittempergher L, Paulson J, Andre F, Bonnefoi H, Loi S, Loibl S, Gelber R, Caballero C, Fumagalli D, Dreezen C, Bernards R, van ‘t Veer L, Piccart M. Abstract PD3-01: BluePrint performance in predicting pertuzumab benefit in genomically HER2-positive patients: A biomarker analysis of the APHINITY trial. Cancer Research 2021, 81: pd3-01-pd3-01. DOI: 10.1158/1538-7445.sabcs20-pd3-01.
Abstract PD3-06: Updated results from DESTINY-breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd ) in HER2 positive metastatic breast cancerModi S, Saura C, Yamashita T, Park Y, Kim S, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im S, Lee K, Hurvitz S, Cortes J, Lee C, Liu Y, Zhang L, Shahidi J, Yver A, Baselga J, Krop I. Abstract PD3-06: Updated results from DESTINY-breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd ) in HER2 positive metastatic breast cancer. Cancer Research 2021, 81: pd3-06-pd3-06. DOI: 10.1158/1538-7445.sabcs20-pd3-06.
Abstract PD9-06: Peripheral blood gene signatures predict response to neoadjuvant chemotherapy in breast cancer patientsAxelrod M, Gonzalez-Ericsson P, Sun X, Bergman R, Donaldson J, Tolaney S, Krop I, Garrido-Castro A, Sanders M, Mayer I, Balko J. Abstract PD9-06: Peripheral blood gene signatures predict response to neoadjuvant chemotherapy in breast cancer patients. Cancer Research 2021, 81: pd9-06-pd9-06. DOI: 10.1158/1538-7445.sabcs20-pd9-06.
Abstract PS10-01: 6-year absolute invasive disease-free survival (IDFS) benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A STEPP analysis of the APHINITY (BIG 4-11) trialGelber R, Wang X, Cole B, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhardt M. Abstract PS10-01: 6-year absolute invasive disease-free survival (IDFS) benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A STEPP analysis of the APHINITY (BIG 4-11) trial. Cancer Research 2021, 81: ps10-01-ps10-01. DOI: 10.1158/1538-7445.sabcs20-ps10-01.
Abstract PS11-11: Targeted safety events from a phase I/Ib study evaluating GDC-0077 alone and in combination with endocrine therapy (ET) ± palbociclib (palbo) in patients (pts) with PIK3CA -mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)Olivera M, Jhaveri K, Juric D, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Schmid P, Turner N, Varga A, Lei G, Royer-Joo S, Thomas P, Schutzman J, Saura C. Abstract PS11-11: Targeted safety events from a phase I/Ib study evaluating GDC-0077 alone and in combination with endocrine therapy (ET) ± palbociclib (palbo) in patients (pts) with PIK3CA -mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC). Cancer Research 2021, 81: ps11-11-ps11-11. DOI: 10.1158/1538-7445.sabcs20-ps11-11.
Genomic Characterization of de novo Metastatic Breast CancerGarrido-Castro AC, Spurr LF, Hughes ME, Li YY, Cherniack AD, Kumari P, Lloyd MR, Bychkovsky B, Barroso-Sousa R, Di Lascio S, Jain E, Files J, Mohammed-Abreu A, Krevalin M, MacKichan C, Barry WT, Guo H, Xia D, Cerami E, Rollins BJ, MacConaill LE, Lindeman NI, Krop IE, Johnson BE, Wagle N, Winer EP, Dillon DA, Lin NU. Genomic Characterization of de novo Metastatic Breast Cancer. Clinical Cancer Research 2021, 27: 1105-1118. PMID: 33293374, PMCID: PMC7887078, DOI: 10.1158/1078-0432.ccr-20-1720.
Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-UpPiccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pieńkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. Journal Of Clinical Oncology 2021, 39: 1448-1457. PMID: 33539215, DOI: 10.1200/jco.20.01204.
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast CancerKrop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.
Phase II trial of carboplatin and bevacizumab in patients with breast cancer brain metastasesLeone JP, Emblem KE, Weitz M, Gelman RS, Schneider BP, Freedman RA, Younger J, Pinho MC, Sorensen AG, Gerstner ER, Harris G, Krop IE, Morganstern D, Sohl J, Hu J, Kasparian E, Winer EP, Lin NU. Phase II trial of carboplatin and bevacizumab in patients with breast cancer brain metastases. Breast Cancer Research 2020, 22: 131. PMID: 33256829, PMCID: PMC7706261, DOI: 10.1186/s13058-020-01372-w.
Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial ☆Dent S, Cortés J, Im Y, Diéras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial ☆. Annals Of Oncology 2020, 32: 197-207. PMID: 33186740, PMCID: PMC8457522, DOI: 10.1016/j.annonc.2020.10.596.
CTNI-02. TBCRC049: A PHASE II STUDY TO ASSESS THE SAFETY AND EFFICACY OF THE COMBINATION OF TUCATINIB, TRASTUZUMAB AND CAPECITABINE FOR THE TREATMENT OF LEPTOMENINGEAL METASTASIS IN HER2 POSITIVE BR1AST CANCERMurthy R, O’Brien B, Berry D, Navin N, Johnson J, Gule-Monroe M, Leone J, Specht J, Melisko M, Morikawa A, Storniolo A, Brufsky A, Pohlmann P, Park D, Park B, Krop I, Lin N, Rimawi M, Wolff A, Forero-Torres A, Stringer-Reasor E. CTNI-02. TBCRC049: A PHASE II STUDY TO ASSESS THE SAFETY AND EFFICACY OF THE COMBINATION OF TUCATINIB, TRASTUZUMAB AND CAPECITABINE FOR THE TREATMENT OF LEPTOMENINGEAL METASTASIS IN HER2 POSITIVE BR1AST CANCER. Neuro-Oncology 2020, 22: ii41-ii41. PMCID: PMC7650439, DOI: 10.1093/neuonc/noaa215.169.
CDK4/6 inhibition reprograms the breast cancer enhancer landscape by stimulating AP-1 transcriptional activityWatt AC, Cejas P, DeCristo MJ, Metzger-Filho O, Lam EYN, Qiu X, BrinJones H, Kesten N, Coulson R, Font-Tello A, Lim K, Vadhi R, Daniels VW, Montero J, Taing L, Meyer CA, Gilan O, Bell CC, Korthauer KD, Giambartolomei C, Pasaniuc B, Seo JH, Freedman ML, Ma C, Ellis MJ, Krop I, Winer E, Letai A, Brown M, Dawson MA, Long HW, Zhao JJ, Goel S. CDK4/6 inhibition reprograms the breast cancer enhancer landscape by stimulating AP-1 transcriptional activity. Nature Cancer 2020, 2: 34-48. PMID: 33997789, PMCID: PMC8115221, DOI: 10.1038/s43018-020-00135-y.
Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancerGarrido-Castro AC, Saura C, Barroso-Sousa R, Guo H, Ciruelos E, Bermejo B, Gavilá J, Serra V, Prat A, Paré L, Céliz P, Villagrasa P, Li Y, Savoie J, Xu Z, Arteaga CL, Krop IE, Solit DB, Mills GB, Cantley LC, Winer EP, Lin NU, Rodon J. Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. Breast Cancer Research 2020, 22: 120. PMID: 33138866, PMCID: PMC7607628, DOI: 10.1186/s13058-020-01354-y.
Changes in Peripheral and Local Tumor Immunity after Neoadjuvant Chemotherapy Reshape Clinical Outcomes in Patients with Breast CancerAxelrod ML, Nixon MJ, Gonzalez-Ericsson PI, Bergman RE, Pilkinton MA, McDonnell WJ, Sanchez V, Opalenik SR, Loi S, Zhou J, Mackay S, Rexer BN, Abramson VG, Jansen VM, Mallal S, Donaldson J, Tolaney SM, Krop IE, Garrido-Castro AC, Marotti JD, Shee K, Miller TW, Sanders ME, Mayer IA, Salgado R, Balko JM. Changes in Peripheral and Local Tumor Immunity after Neoadjuvant Chemotherapy Reshape Clinical Outcomes in Patients with Breast Cancer. Clinical Cancer Research 2020, 26: 5668-5681. PMID: 32826327, PMCID: PMC7642197, DOI: 10.1158/1078-0432.ccr-19-3685.
TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes.Tung NM, Robson ME, Ventz S, Santa-Maria CA, Nanda R, Marcom PK, Shah PD, Ballinger TJ, Yang ES, Vinayak S, Melisko M, Brufsky A, DeMeo M, Jenkins C, Domchek S, D'Andrea A, Lin NU, Hughes ME, Carey LA, Wagle N, Wulf GM, Krop IE, Wolff AC, Winer EP, Garber JE. TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. Journal Of Clinical Oncology 2020, 38: 4274-4282. PMID: 33119476, DOI: 10.1200/jco.20.02151.
Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. Journal Of Clinical Oncology 2020, 38: 4184-4193. PMID: 33095682, PMCID: PMC7723687, DOI: 10.1200/jco.20.01276.
Effect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor–Positive, ERBB2-Negative Metastatic Breast CancerTolaney SM, Barroso-Sousa R, Keenan T, Li T, Trippa L, Vaz-Luis I, Wulf G, Spring L, Sinclair NF, Andrews C, Pittenger J, Richardson ET, Dillon D, Lin NU, Overmoyer B, Partridge AH, Van Allen E, Mittendorf EA, Winer EP, Krop IE. Effect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor–Positive, ERBB2-Negative Metastatic Breast Cancer. JAMA Oncology 2020, 6: 1598-1605. PMID: 32880602, PMCID: PMC7489368, DOI: 10.1001/jamaoncol.2020.3524.
PI3K pathway biomarkers and clinical response in a phase I/Ib study of GDC-0077 in hormone receptor-positive/HER2-negative breast cancer (HR+/HER2– BC)Gambardella V, Cervantes A, Bedard P, Hamilton E, Italiano A, Jhaveri K, Juric D, Kalinsky K, Krop I, Oliveira M, Saura C, Schmid P, Turner N, Varga A, Liu B, Chen J, Aimi J, Royer-Joo S, Schutzman J, Hutchinson K. PI3K pathway biomarkers and clinical response in a phase I/Ib study of GDC-0077 in hormone receptor-positive/HER2-negative breast cancer (HR+/HER2– BC). Annals Of Oncology 2020, 31: s381-s382. DOI: 10.1016/j.annonc.2020.08.438.
Abstract CT109: A phase I/Ib study evaluating GDC-0077 plus fulvestrant in patients with PIK3CA -mutant, hormone receptor-positive/HER2-negative breast cancerKalinsky K, Juric D, Bedard P, Oliveira M, Cervantes A, Hamilton E, Krop I, Turner N, Schmid P, Varga A, Italiano A, Veitch Z, Saura C, Gambardella V, Cheeti S, Kotani N, Lei G, Hutchinson K, Royer-Joo S, Vaze A, Schutzman J, Jhaveri K. Abstract CT109: A phase I/Ib study evaluating GDC-0077 plus fulvestrant in patients with PIK3CA -mutant, hormone receptor-positive/HER2-negative breast cancer. Cancer Research 2020, 80: ct109-ct109. DOI: 10.1158/1538-7445.am2020-ct109.
TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarkerMayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Annals Of Oncology 2020, 31: 1518-1525. PMID: 32798689, PMCID: PMC8437015, DOI: 10.1016/j.annonc.2020.08.2064.
Reply to T.J.A. Dekker.Modi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Reply to T.J.A. Dekker. Journal Of Clinical Oncology 2020, 38: 3351-3352. PMID: 32658630, DOI: 10.1200/jco.20.01212.
Publisher Correction: Single-arm, open-label phase 2 trial of pembrolizumab in patients with leptomeningeal carcinomatosisBrastianos PK, Lee EQ, Cohen JV, Tolaney SM, Lin NU, Wang N, Chukwueke U, White MD, Nayyar N, Kim A, Alvarez-Breckenridge C, Krop I, Mahar MK, Bertalan MS, Shaw B, Mora JL, Goss N, Subramanian M, Nayak L, Dietrich J, Forst DA, Nahed BV, Batchelor TT, Shih HA, Gerstner ER, Moy B, Lawrence D, Giobbie-Hurder A, Carter SL, Oh K, Cahill DP, Sullivan RJ. Publisher Correction: Single-arm, open-label phase 2 trial of pembrolizumab in patients with leptomeningeal carcinomatosis. Nature Medicine 2020, 26: 1309-1309. PMID: 32555425, DOI: 10.1038/s41591-020-0978-1.
Single-arm, open-label phase 2 trial of pembrolizumab in patients with leptomeningeal carcinomatosisBrastianos PK, Lee EQ, Cohen JV, Tolaney SM, Lin NU, Wang N, Chukwueke U, White MD, Nayyar N, Kim A, Alvarez-Breckenridge C, Krop I, Mahar MK, Bertalan MS, Shaw B, Mora JL, Goss N, Subramanian M, Nayak L, Dietrich J, Forst DA, Nahed BV, Batchelor TT, Shih HA, Gerstner ER, Moy B, Lawrence D, Giobbie-Hurder A, Carter SL, Oh K, Cahill DP, Sullivan RJ. Single-arm, open-label phase 2 trial of pembrolizumab in patients with leptomeningeal carcinomatosis. Nature Medicine 2020, 26: 1280-1284. PMID: 32483359, DOI: 10.1038/s41591-020-0918-0.
Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast CancerBarroso-Sousa R, Keenan TE, Pernas S, Exman P, Jain E, Garrido-Castro AC, Hughes M, Bychkovsky B, Umeton R, Files JL, Lindeman NI, MacConaill LE, Hodi FS, Krop IE, Dillon D, Winer EP, Wagle N, Lin NU, Mittendorf EA, Van Allen EM, Tolaney SM. Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2020, 26: 2565-2572. PMID: 32019858, PMCID: PMC7269810, DOI: 10.1158/1078-0432.ccr-19-3507.
Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast CancerParsons HA, Rhoades J, Reed SC, Gydush G, Ram P, Exman P, Xiong K, Lo CC, Li T, Fleharty M, Kirkner GJ, Rotem D, Cohen O, Yu F, Fitarelli-Kiehl M, Leong KW, Hughes ME, Rosenberg SM, Collins LC, Miller KD, Blumenstiel B, Trippa L, Cibulskis C, Neuberg DS, DeFelice M, Freeman SS, Lennon NJ, Wagle N, Ha G, Stover DG, Choudhury AD, Getz G, Winer EP, Meyerson M, Lin NU, Krop I, Love JC, Makrigiorgos GM, Partridge AH, Mayer EL, Golub TR, Adalsteinsson VA. Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer. Clinical Cancer Research 2020, 26: 2556-2564. PMID: 32170028, PMCID: PMC7654718, DOI: 10.1158/1078-0432.ccr-19-3005.
Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastasesFilho O, Leone JP, Li T, Tan-Wasielewski Z, Trippa L, Barry WT, Younger J, Lawler E, Walker L, Freedman RA, Tolaney SM, Krop I, Winer EP, Lin NU. Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases. Annals Of Oncology 2020, 31: 1231-1239. PMID: 32461105, DOI: 10.1016/j.annonc.2020.05.014.
TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).Tung N, Robson M, Ventz S, Santa-Maria C, Marcom P, Nanda R, Shah P, Ballinger T, Yang E, Melisko M, Brufsky A, Vinayak S, Demeo M, Jenkins C, Domchek S, Wulf G, Krop I, Wolff A, Winer E, Garber J. TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded). Journal Of Clinical Oncology 2020, 38: 1002-1002. DOI: 10.1200/jco.2020.38.15_suppl.1002.
A phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC).Waks A, Keenan T, Li T, Tayob N, Wulf G, Richardson E, Mittendorf E, Overmoyer B, Krop I, Winer E, Van Allen E, Agudo J, Tolaney S. A phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC). Journal Of Clinical Oncology 2020, 38: 1046-1046. DOI: 10.1200/jco.2020.38.15_suppl.1046.
Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).Harbeck N, Im S, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis P, Gianni L, Swain S, Im Y, De Laurentiis M, Nowecki Z, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer E, Krop I. Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Journal Of Clinical Oncology 2020, 38: 500-500. DOI: 10.1200/jco.2020.38.15_suppl.500.
SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer.Beckwith H, Medgyesy D, Abraham J, Nanda R, Tkaczuk K, Krop I, Pusztai L, Modi S, Mita M, Specht J, Hurvitz S, Han H, Kalinsky K, Wilks S, O'Shaughnessy J, Hart L, Rugo H, Mitri Z, Garfin P, Burris III H. SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer. Journal Of Clinical Oncology 2020, 38: tps1104-tps1104. DOI: 10.1200/jco.2020.38.15_suppl.tps1104.
A multiparameter classifier to predict response to lapatinib plus trastuzumab (LT) without chemotherapy in HER2+ breast cancer (BC).Veeraraghavan J, Gutierrez C, De Angelis C, Wang T, Pascual T, Weigelt B, Galvan P, Rexer B, Forero-Torres A, Wolff A, Nanda R, Storniolo A, Krop I, Goetz M, Reis-Filho J, Hilsenbeck S, Prat A, Osborne C, Schiff R, Rimawi M. A multiparameter classifier to predict response to lapatinib plus trastuzumab (LT) without chemotherapy in HER2+ breast cancer (BC). Journal Of Clinical Oncology 2020, 38: 1011-1011. DOI: 10.1200/jco.2020.38.15_suppl.1011.
Trastuzumab deruxtecan for HER2-positive metastatic breast cancer: DESTINY-Breast01 subgroup analysis.Modi S, Andre F, Krop I, Saura C, Yamashita T, Kim S, Tamura K, Chen S, Suto F, Kuwahara Y, Lee C, Park Y. Trastuzumab deruxtecan for HER2-positive metastatic breast cancer: DESTINY-Breast01 subgroup analysis. Journal Of Clinical Oncology 2020, 38: 1036-1036. DOI: 10.1200/jco.2020.38.15_suppl.1036.
Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB).Okines A, Paplomata E, Wahl T, Wright G, Sutherland S, Jakobsen E, Valdes F, Chan A, Clark A, Conlin A, Lustberg M, Specht J, Pluard T, Zhu X, Krop I, Gelmon K, Slamon D, Ramos J, An G, Hamilton E. Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB). Journal Of Clinical Oncology 2020, 38: 1043-1043. DOI: 10.1200/jco.2020.38.15_suppl.1043.
Optimizing Radiation Therapy to Boost Systemic Immune Responses in Breast Cancer: A Critical Review for Breast Radiation OncologistsHo AY, Wright JL, Blitzblau RC, Mutter RW, Duda D, Norton L, Bardia A, Spring L, Isakoff SJ, Chen JH, Grassberger C, Bellon JR, Beriwal S, Khan AJ, Speers C, Dunn SA, Thompson A, Santa-Maria CA, Krop IE, Mittendorf E, King TA, Gupta GP. Optimizing Radiation Therapy to Boost Systemic Immune Responses in Breast Cancer: A Critical Review for Breast Radiation Oncologists. International Journal Of Radiation Oncology • Biology • Physics 2020, 108: 227-241. PMID: 32417409, PMCID: PMC7646202, DOI: 10.1016/j.ijrobp.2020.05.011.
3O Mutation analysis of circulating tumour DNA from baseline and study discontinuation samples in SANDPIPER, a phase III study of taselisib or placebo with fulvestrant in oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutant advanced breast cancerJacot W, Savage H, Dent S, Cortés J, Im Y, Dieras V, Harbeck N, Krop I, Chen J, Sokol E, Schimmoller F, Hsu J, De Laurentiis M, Wilson T. 3O Mutation analysis of circulating tumour DNA from baseline and study discontinuation samples in SANDPIPER, a phase III study of taselisib or placebo with fulvestrant in oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutant advanced breast cancer. Annals Of Oncology 2020, 31: s16. DOI: 10.1016/j.annonc.2020.03.139.
Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid TumorsTsurutani J, Iwata H, Krop I, Jänne PA, Doi T, Takahashi S, Park H, Redfern C, Tamura K, Wise-Draper TM, Saito K, Sugihara M, Singh J, Jikoh T, Gallant G, Li BT. Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors. Cancer Discovery 2020, 10: 688-701. PMID: 32213540, PMCID: PMC8292921, DOI: 10.1158/2159-8290.cd-19-1014.
Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysisParacha N, Reyes A, Diéras V, Krop I, Pivot X, Urruticoechea A. Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis. Breast Cancer Research And Treatment 2020, 180: 597-609. PMID: 32100144, PMCID: PMC7103014, DOI: 10.1007/s10549-020-05577-7.
TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial).Tung N, Arun B, Hacker MR, Hofstatter E, Toppmeyer DL, Isakoff SJ, Borges V, Legare RD, Isaacs C, Wolff AC, Marcom PK, Mayer EL, Lange PB, Goss AJ, Jenkins C, Krop IE, Winer EP, Schnitt SJ, Garber JE. TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial). Journal Of Clinical Oncology 2020, 38: 1539-1548. PMID: 32097092, PMCID: PMC8462533, DOI: 10.1200/jco.19.03292.
Reversion and non-reversion mechanisms of resistance to PARP inhibitor or platinum chemotherapy in BRCA1/2-mutant metastatic breast cancerWaks AG, Cohen O, Kochupurakkal B, Kim D, Dunn CE, Buendia J, Wander S, Helvie K, Lloyd MR, Marini L, Hughes ME, Freeman SS, Ivy SP, Geradts J, Isakoff S, LoRusso P, Adalsteinsson VA, Tolaney SM, Matulonis U, Krop IE, D’Andrea A, Winer EP, Lin NU, Shapiro GI, Wagle N. Reversion and non-reversion mechanisms of resistance to PARP inhibitor or platinum chemotherapy in BRCA1/2-mutant metastatic breast cancer. Annals Of Oncology 2020, 31: 590-598. PMID: 32245699, PMCID: PMC7946408, DOI: 10.1016/j.annonc.2020.02.008.
Abstract GS6-03: Cisplatin versus doxorubicin/cyclophosphamide as neoadjuvant treatment in germline BRCA mutation carriers ( BRCA carriers) with HER2-negative breast cancer: Results from the INFORM trial (TBCRC 031)Tung N, Arun B, Hofstatter E, Hacker M, Toppmeyer D, Isakoff S, Borges V, Legare R, Isaacs C, Wolff A, Marcom P, Mayer E, Lange P, Goss A, Krop I, Winer E, Schnitt S, Garber J. Abstract GS6-03: Cisplatin versus doxorubicin/cyclophosphamide as neoadjuvant treatment in germline BRCA mutation carriers ( BRCA carriers) with HER2-negative breast cancer: Results from the INFORM trial (TBCRC 031). Cancer Research 2020, 80: gs6-03-gs6-03. DOI: 10.1158/1538-7445.sabcs19-gs6-03.
Abstract P2-13-02: Chemotherapy-related amenorrhea (CRA) after adjuvant trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT trial)Ruddy K, Trippa L, Hu J, Barry W, Dang C, Yardley D, Isakoff S, Valero V, Faggen M, Mulvey T, Bose R, Weckstein D, Wolff A, Reeder-Hayes K, Rugo H, Ramaswamy B, Zuckerman D, Hart L, Gadi V, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett A, Marcom P, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz R, DeMeo M, Burstein H, Winer E, Krop I, Partridge A, Tolaney S. Abstract P2-13-02: Chemotherapy-related amenorrhea (CRA) after adjuvant trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT trial). Cancer Research 2020, 80: p2-13-02-p2-13-02. DOI: 10.1158/1538-7445.sabcs19-p2-13-02.
Abstract P3-09-16: Fecal microbiome and association with outcomes among patients (pts) receiving eribulin (E) +/- pembrolizumab (P) for hormone receptor positive (HR+) metastatic breast cancer (MBC)de Sousa R, Ajami N, Keenan T, Andrews C, Pittenger J, Wulf G, Spring L, Krop I, Winer E, Mittendorf E, Tolaney S. Abstract P3-09-16: Fecal microbiome and association with outcomes among patients (pts) receiving eribulin (E) +/- pembrolizumab (P) for hormone receptor positive (HR+) metastatic breast cancer (MBC). Cancer Research 2020, 80: p3-09-16-p3-09-16. DOI: 10.1158/1538-7445.sabcs19-p3-09-16.
Abstract GS1-03: [Fam-] trastuzumab deruxtecan (T-DXd; DS-8201a) in subjects with HER2-positive metastatic breast cancer previously treated with T-DM1: A phase 2, multicenter, open-label study (DESTINY-Breast01)Krop I, Saura C, Yamashita T, Park Y, Kim S, Tamura K, André F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im S, Lee K, Hurvitz S, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Modi S. Abstract GS1-03: [Fam-] trastuzumab deruxtecan (T-DXd; DS-8201a) in subjects with HER2-positive metastatic breast cancer previously treated with T-DM1: A phase 2, multicenter, open-label study (DESTINY-Breast01). Cancer Research 2020, 80: gs1-03-gs1-03. DOI: 10.1158/1538-7445.sabcs19-gs1-03.
Abstract OT1-07-04: [Fam-] trastuzumab deruxtecan (T-DXd; DS-8201a) vs investigator’s choice of treatment in subjects with HER2-positive, unresectable and/or metastatic breast cancer who previously received T-DM1: A randomized, phase 3 trial (DESTINY-Breast02)André F, Shahidi J, Lee C, Wang K, Krop I. Abstract OT1-07-04: [Fam-] trastuzumab deruxtecan (T-DXd; DS-8201a) vs investigator’s choice of treatment in subjects with HER2-positive, unresectable and/or metastatic breast cancer who previously received T-DM1: A randomized, phase 3 trial (DESTINY-Breast02). Cancer Research 2020, 80: ot1-07-04-ot1-07-04. DOI: 10.1158/1538-7445.sabcs19-ot1-07-04.
Abstract OT1-08-04: A first-in-human phase Ia dose escalation study of GDC-0077, a p110a-selective and mutant-degrading PI3K inhibitor, in patients with PIK3CA -mutant solid tumorsJuric D, Kalinsky K, Oliveira M, Cervantes A, Bedard P, Krop I, Hamilton E, Schmid P, Varga A, Turner N, Italiano A, Saura C, Gambardella V, Veitch Z, Dickmann L, Kotani N, Fredrickson J, Kapp A, Hutchinson K, Royer-Joo S, Vaze A, Schutzman J, Jhaveri K. Abstract OT1-08-04: A first-in-human phase Ia dose escalation study of GDC-0077, a p110a-selective and mutant-degrading PI3K inhibitor, in patients with PIK3CA -mutant solid tumors. Cancer Research 2020, 80: ot1-08-04-ot1-08-04. DOI: 10.1158/1538-7445.sabcs19-ot1-08-04.
Abstract OT2-01-02: TBCRC049: A phase II non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab and capecitabine for treatment of leptomeningeal metastases in HER2 positive breast cancer TBCRC049: A phase II non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab and capecitabine for treatment of leptomeningeal metastases in HER2 positive breast cancerMurthy R, O'Brien B, Hess K, Navin N, Johnson J, Gule-Monroe M, Leone J, Specht J, Melisko M, Morikawa A, Storniolo A, Brufsky A, Pohlmann P, Park D, Park B, Krop I, Lin N, Wolff A, Forerro-Torres A, Stringer-Reasor E. Abstract OT2-01-02: TBCRC049: A phase II non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab and capecitabine for treatment of leptomeningeal metastases in HER2 positive breast cancer TBCRC049: A phase II non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab and capecitabine for treatment of leptomeningeal metastases in HER2 positive breast cancer. Cancer Research 2020, 80: ot2-01-02-ot2-01-02. DOI: 10.1158/1538-7445.sabcs19-ot2-01-02.
Abstract OT2-07-01: A phase 2 study of futibatinib (TAS-120) in metastatic breast cancers harboring fibroblast growth factor receptor ( FGFR ) amplifications (FOENIX-MBC2)Turner N, Krop I, Bardia A, Damodaran S, Martin M, Benhadji K, He Y, Ptaszynski M, Arteaga C. Abstract OT2-07-01: A phase 2 study of futibatinib (TAS-120) in metastatic breast cancers harboring fibroblast growth factor receptor ( FGFR ) amplifications (FOENIX-MBC2). Cancer Research 2020, 80: ot2-07-01-ot2-07-01. DOI: 10.1158/1538-7445.sabcs19-ot2-07-01.
Abstract P1-19-46: A phase Ib dose escalation study evaluating the mutant selective PI3K-alpha inhibitor GDC-0077 (G) in combination with letrozole (L) with and without palbociclib (P) in patients with PIK3CA -mutant HR+/HER2- breast cancerJhaveri K, Kalinsky K, Bedard P, Cervantes A, Saura C, Krop I, Hamilton E, Schmid P, Varga A, Turner N, Italiano A, Gambardella V, Veitch Z, Oliveira M, Dickmann L, Kotani N, Kapp A, Hutchinson K, Royer-Joo S, Vaze A, Schutzman J, Juric D. Abstract P1-19-46: A phase Ib dose escalation study evaluating the mutant selective PI3K-alpha inhibitor GDC-0077 (G) in combination with letrozole (L) with and without palbociclib (P) in patients with PIK3CA -mutant HR+/HER2- breast cancer. Cancer Research 2020, 80: p1-19-46-p1-19-46. DOI: 10.1158/1538-7445.sabcs19-p1-19-46.
Abstract P5-01-03: Ultrasensitive detection of minimal residual disease in patients treated for breast cancerParsons H, Rhoades J, Reed S, Gydush G, Ram P, Exman P, Xiong K, Lo C, Li T, Fleharty M, Kirkner G, Rotem D, Cohen O, Hughes M, Rosenberg S, Collins L, Miller K, Blumenstiel B, Cibulskis C, Neuberg D, Freeman S, Lennon N, Wagle N, Ha G, Stover D, Choudhury A, Getz G, Meyerson M, Lin N, Krop I, Love J, Makrigiorgos G, Partridge A, Mayer E, Golub T, Adalsteinsson V. Abstract P5-01-03: Ultrasensitive detection of minimal residual disease in patients treated for breast cancer. Cancer Research 2020, 80: p5-01-03-p5-01-03. DOI: 10.1158/1538-7445.sabcs19-p5-01-03.
Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low–Expressing Advanced Breast Cancer: Results From a Phase Ib StudyModi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low–Expressing Advanced Breast Cancer: Results From a Phase Ib Study. Journal Of Clinical Oncology 2020, 38: 1887-1896. PMID: 32058843, PMCID: PMC7280051, DOI: 10.1200/jco.19.02318.
TBCRC023: A Randomized Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab Without Chemotherapy for 12 versus 24 Weeks in Patients with HER2-Positive Breast CancerRimawi MF, Niravath P, Wang T, Rexer BN, Forero A, Wolff AC, Nanda R, Storniolo AM, Krop I, Goetz MP, Nangia JR, Jiralerspong S, Pavlick A, Veeraraghavan J, De Angelis C, Gutierrez C, Schiff R, Hilsenbeck SG, Osborne CK, Consortium O. TBCRC023: A Randomized Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab Without Chemotherapy for 12 versus 24 Weeks in Patients with HER2-Positive Breast Cancer. Clinical Cancer Research 2020, 26: 821-827. PMID: 31662331, DOI: 10.1158/1078-0432.ccr-19-0851.
A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast CancerBarroso-Sousa R, Krop IE, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson ET, Pastorello RG, Winer EP, Mittendorf EA, Bellon JR, Schoenfeld JD, Tolaney SM. A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clinical Breast Cancer 2020, 20: 238-245. PMID: 32113750, DOI: 10.1016/j.clbc.2020.01.012.
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast CancerMurthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Müller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. New England Journal Of Medicine 2019, 382: 597-609. PMID: 31825569, DOI: 10.1056/nejmoa1914609.
Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast CancerModi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. New England Journal Of Medicine 2019, 382: 610-621. PMID: 31825192, PMCID: PMC7458671, DOI: 10.1056/nejmoa1914510.
Identifying ERBB2 Activating Mutations in HER2-Negative Breast Cancer: Clinical Impact of Institute-Wide Genomic Testing and Enrollment in Matched Therapy Trials.Exman P, Garrido-Castro AC, Hughes ME, Freedman RA, Li T, Trippa L, Bychkovsky BL, Barroso-Sousa R, Di Lascio S, Mackichan C, Lloyd MR, Krevalin M, Cerami E, Merrill MS, Santiago R, Crowley L, Kuhnly N, Files J, Lindeman NI, MacConaill LE, Kumari P, Tolaney SM, Krop IE, Bose R, Johnson BE, Ma CX, Dillon DA, Winer EP, Wagle N, Lin NU. Identifying ERBB2 Activating Mutations in HER2-Negative Breast Cancer: Clinical Impact of Institute-Wide Genomic Testing and Enrollment in Matched Therapy Trials. JCO Precision Oncology 2019, 3: 1-9. PMID: 32923853, PMCID: PMC7446367, DOI: 10.1200/po.19.00087.
174O Predictive and prognostic value of B-cell gene-expression signatures and B-cell receptor (BCR) repertoire in HER2+ breast cancer: A correlative analysis of the CALGB 40601 clinical trial (Alliance)Fernandez-Martinez A, Tanioka M, Fan C, Parker J, Hoadley K, Krop I, Partridge A, Carey L, Perou C. 174O Predictive and prognostic value of B-cell gene-expression signatures and B-cell receptor (BCR) repertoire in HER2+ breast cancer: A correlative analysis of the CALGB 40601 clinical trial (Alliance). Annals Of Oncology 2019, 30: v55. DOI: 10.1093/annonc/mdz240.
O1-8-4 [Encore] Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancerTakahashi S, Modi S, Tsurutani J, Krop I, Iwata H, Wada R, Yin O, Garimella T, Sugihara M, Zhang L, Lee C, Saito K, Kawasaki Y, Yver A, Tamura K. O1-8-4 [Encore] Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancer. Annals Of Oncology 2019, 30: vi84. DOI: 10.1093/annonc/mdz339.009.
Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022Freedman RA, Gelman RS, Agar NYR, Santagata S, Randall EC, Lopez B, Connolly RM, Dunn IF, Van Poznak CH, Anders CK, Melisko ME, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Moy B, Blackwell KL, Puhalla SL, Ibrahim N, Moynihan TJ, Nangia J, Tung N, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, Consortium T. Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022. Clinical Breast Cancer 2019, 20: 145-151.e2. PMID: 31558424, PMCID: PMC7035200, DOI: 10.1016/j.clbc.2019.07.011.
The Immune Microenvironment in Hormone Receptor–Positive Breast Cancer Before and After Preoperative ChemotherapyWaks AG, Stover DG, Guerriero JL, Dillon D, Barry WT, Gjini E, Hartl C, Lo W, Savoie J, Brock J, Wesolowski R, Li Z, Damicis A, Philips AV, Wu Y, Yang F, Sullivan A, Danaher P, Brauer HA, Osmani W, Lipschitz M, Hoadley KA, Goldberg M, Perou CM, Rodig S, Winer EP, Krop IE, Mittendorf EA, Tolaney SM. The Immune Microenvironment in Hormone Receptor–Positive Breast Cancer Before and After Preoperative Chemotherapy. Clinical Cancer Research 2019, 25: 4644-4655. PMID: 31061067, PMCID: PMC6677598, DOI: 10.1158/1078-0432.ccr-19-0173.
Current Landscape of Immunotherapy in Breast CancerAdams S, Gatti-Mays ME, Kalinsky K, Korde LA, Sharon E, Amiri-Kordestani L, Bear H, McArthur HL, Frank E, Perlmutter J, Page DB, Vincent B, Hayes JF, Gulley JL, Litton JK, Hortobagyi GN, Chia S, Krop I, White J, Sparano J, Disis ML, Mittendorf EA. Current Landscape of Immunotherapy in Breast Cancer. JAMA Oncology 2019, 5: 1205-1214. PMID: 30973611, PMCID: PMC8452050, DOI: 10.1001/jamaoncol.2018.7147.
A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancerAbramson VG, Oliveira M, Cervantes A, Wildiers H, Patel MR, Bauer TM, Bedard PL, Becerra C, Richey S, Wei MC, Reyner E, Bond J, Cui N, Wilson TR, Moore HM, Saura C, Krop IE. A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer. Breast Cancer Research And Treatment 2019, 178: 121-133. PMID: 31368034, DOI: 10.1007/s10549-019-05360-3.
Abstract CT015: Phase I dose-escalation study of the allosteric AKT inhibitor BAY 1125976 in advanced solid cancerSchneeweiss A, Hess D, Joerger M, Varga A, Moulder S, Ma C, Krop I, Hurvitz S, Rentzsch C, Rudolph M, Boix O, Wilkinson G, Lindbom L, Lagkadinou E, Ocker M. Abstract CT015: Phase I dose-escalation study of the allosteric AKT inhibitor BAY 1125976 in advanced solid cancer. 2019, ct015-ct015. DOI: 10.1158/1538-7445.sabcs18-ct015.
Abstract CT015: Phase I dose-escalation study of the allosteric AKT inhibitor BAY 1125976 in advanced solid cancerSchneeweiss A, Hess D, Joerger M, Varga A, Moulder S, Ma C, Krop I, Hurvitz S, Rentzsch C, Rudolph M, Boix O, Wilkinson G, Lindbom L, Lagkadinou E, Ocker M. Abstract CT015: Phase I dose-escalation study of the allosteric AKT inhibitor BAY 1125976 in advanced solid cancer. Cancer Research 2019, 79: ct015-ct015. DOI: 10.1158/1538-7445.am2019-ct015.
A combinatorial biomarker predicts pathologic complete response to neoadjuvant lapatinib and trastuzumab without chemotherapy in patients with HER2+ breast cancerVeeraraghavan J, De Angelis C, Mao R, Wang T, Herrera S, Pavlick AC, Contreras A, Nuciforo P, Mayer IA, Forero A, Nanda R, Goetz MP, Chang JC, Wolff AC, Krop IE, Fuqua SAW, Prat A, Hilsenbeck SG, Weigelt B, Reis-Filho JS, Gutierrez C, Osborne CK, Rimawi MF, Schiff R. A combinatorial biomarker predicts pathologic complete response to neoadjuvant lapatinib and trastuzumab without chemotherapy in patients with HER2+ breast cancer. Annals Of Oncology 2019, 30: 927-933. PMID: 30903140, PMCID: PMC6594453, DOI: 10.1093/annonc/mdz076.
Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).Tolaney S, Barroso-Sousa R, Keenan T, Trippa L, Hu J, Luis I, Wulf G, Spring L, Sinclair N, Andrews C, Pittenger J, Richardson E, Dillon D, Lin N, Overmoyer B, Partridge A, VanAllen E, Mittendorf E, Winer E, Krop I. Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1004-1004. DOI: 10.1200/jco.2019.37.15_suppl.1004.
Genomic landscape of de novo stage IV breast cancer.Garrido-Castro A, Spurr L, Hughes M, Li Y, Cherniack A, Bychkovsky B, Barroso-Sousa R, Di Lascio S, Files J, Kumari P, Cerami E, Krop I, MacConaill L, Lindeman N, Rollins B, Johnson B, Wagle N, Winer E, Dillon D, Lin N. Genomic landscape of de novo stage IV breast cancer. Journal Of Clinical Oncology 2019, 37: 1022-1022. DOI: 10.1200/jco.2019.37.15_suppl.1022.
A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).Barroso-Sousa R, Krop I, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson E, Winer E, Mittendorf E, Schoenfeld J, Tolaney S. A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1047-1047. DOI: 10.1200/jco.2019.37.15_suppl.1047.
Reversion and non-reversion mechanisms of resistance (MoR) to PARP inhibitor (PARPi) or platinum chemotherapy (chemotx) in patients (pts) with BRCA1/2 -mutant metastatic breast cancer (MBC).Waks A, Cohen O, Kochupurakkal B, Kim D, Wander S, Buendia-Buendia J, Helvie K, Matulonis U, Krop I, Tolaney S, Winer E, D'Andrea A, Shapiro G, Lin N, Wagle N. Reversion and non-reversion mechanisms of resistance (MoR) to PARP inhibitor (PARPi) or platinum chemotherapy (chemotx) in patients (pts) with BRCA1/2 -mutant metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1085-1085. DOI: 10.1200/jco.2019.37.15_suppl.1085.
HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.Metzger Filho O, Viale G, Trippa L, Li T, Yardley D, Mayer I, Abramson V, Arteaga C, Spring L, Waks A, Janiszewska M, Wrabel E, Demeo M, Bardia A, King T, Polyak K, Winer E, Krop I. HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial. Journal Of Clinical Oncology 2019, 37: 502-502. DOI: 10.1200/jco.2019.37.15_suppl.502.
Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial.Krop I, Paulson J, Campbell C, Kiermaier A, Andre F, Fumagalli D, de Haas S, Salgado R, Denkert C, Loibl S, Bailey A, Lewis Phillips G, Frank E, Piccart M, Viale G, Loi S. Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial. Journal Of Clinical Oncology 2019, 37: 1012-1012. DOI: 10.1200/jco.2019.37.15_suppl.1012.
Genomic-based predictive biomarkers to anti-HER2 therapies: A combined analysis of CALGB 40601 (Alliance) and PAMELA clinical trials.Fernandez-Martinez A, Tanioka M, Fan C, Parker J, Hoadley K, Krop I, Cortes J, Llombart Cussac A, Nuciforo P, Galván P, Pascual T, Partridge A, Prat A, Carey L, Perou C. Genomic-based predictive biomarkers to anti-HER2 therapies: A combined analysis of CALGB 40601 (Alliance) and PAMELA clinical trials. Journal Of Clinical Oncology 2019, 37: 571-571. DOI: 10.1200/jco.2019.37.15_suppl.571.
197TiP Phase III study of [fam-] trastuzumab deruxtecan vs investigator’s choice in T-DM1-pretreated HER2+ breast cancerAndré F, Shahidi J, Lee C, Wang K, Krop I. 197TiP Phase III study of [fam-] trastuzumab deruxtecan vs investigator’s choice in T-DM1-pretreated HER2+ breast cancer. Annals Of Oncology 2019, 30: iii63. DOI: 10.1093/annonc/mdz100.048.
HER2-Enriched Subtype and ERBB2 Expression in HER2-Positive Breast Cancer Treated with Dual HER2 BlockadePrat A, Pascual T, De Angelis C, Gutierrez C, Llombart-Cussac A, Wang T, Cortés J, Rexer B, Paré L, Forero A, Wolff AC, Morales S, Adamo B, Brasó-Maristany F, Vidal M, Veeraraghavan J, Krop I, Galván P, Pavlick AC, Bermejo B, Izquierdo M, Rodrik-Outmezguine V, Reis-Filho JS, Hilsenbeck SG, Oliveira M, Dieci MV, Griguolo G, Fasani R, Nuciforo P, Parker JS, Conte P, Schiff R, Guarneri V, Osborne CK, Rimawi MF. HER2-Enriched Subtype and ERBB2 Expression in HER2-Positive Breast Cancer Treated with Dual HER2 Blockade. Journal Of The National Cancer Institute 2019, 112: 46-54. PMID: 31037288, PMCID: PMC7850037, DOI: 10.1093/jnci/djz042.
Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 studyTamura K, Tsurutani J, Takahashi S, Iwata H, Krop IE, Redfern C, Sagara Y, Doi T, Park H, Murthy RK, Redman RA, Jikoh T, Lee C, Sugihara M, Shahidi J, Yver A, Modi S. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. The Lancet Oncology 2019, 20: 816-826. PMID: 31047803, DOI: 10.1016/s1470-2045(19)30097-x.
Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.
Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast CancerTolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.19.00066. PMID: 30939096, PMCID: PMC7587424, DOI: 10.1200/jco.19.00066.
The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trialBarroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Annals Of Oncology 2019, 30: 575-581. PMID: 30753274, PMCID: PMC8033534, DOI: 10.1093/annonc/mdz047.
TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain MetastasesFreedman RA, Gelman RS, Anders CK, Melisko ME, Parsons HA, Cropp AM, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Connolly RM, Moy B, Van Poznak CH, Blackwell KL, Puhalla SL, Jankowitz RC, Smith KL, Ibrahim N, Moynihan TJ, O’Sullivan C, Nangia J, Niravath P, Tung N, Pohlmann PR, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, . TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases. Journal Of Clinical Oncology 2019, 37: jco.18.01511. PMID: 30860945, PMCID: PMC6494354, DOI: 10.1200/jco.18.01511.
Genomic alterations in breast cancer: level of evidence for actionability according to ESMO Scale for Clinical Actionability of molecular Targets (ESCAT)Condorelli R, Mosele F, Verret B, Bachelot T, Bedard P, Cortes J, Hyman D, Juric D, Krop I, Bieche I, Saura C, Sotiriou C, Cardoso F, Loibl S, Andre F, Turner N. Genomic alterations in breast cancer: level of evidence for actionability according to ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). Annals Of Oncology 2019, 30: 365-373. PMID: 30715161, DOI: 10.1093/annonc/mdz036.
First‐in‐human, phase I study of PF‐06647263, an anti‐EFNA4 calicheamicin antibody–drug conjugate, in patients with advanced solid tumorsGarrido‐Laguna I, Krop I, Burris HA, Hamilton E, Braiteh F, Weise AM, Abu‐Khalaf M, Werner TL, Pirie‐Shepherd S, Zopf CJ, Lakshminarayanan M, Holland JS, Baffa R, Hong DS. First‐in‐human, phase I study of PF‐06647263, an anti‐EFNA4 calicheamicin antibody–drug conjugate, in patients with advanced solid tumors. International Journal Of Cancer 2019, 145: 1798-1808. PMID: 30680712, PMCID: PMC6875752, DOI: 10.1002/ijc.32154.
Abstract OT3-02-07: PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC)Metzger O, Mandrekar S, Loibl S, Mundhenke C, Seiler S, Valagussa P, Lim E, Tripathy D, Winer E, Huang C, Carey L, Francis P, Miller K, Goetz M, Prat A, Loi S, Krop I, Gianni L, Delalogue S, Vaz-Luis I, Dockter T, Lanzillotti J, Ciruelos E, DeMichele A. Abstract OT3-02-07: PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC). Cancer Research 2019, 79: ot3-02-07-ot3-02-07. DOI: 10.1158/1538-7445.sabcs18-ot3-02-07.
Abstract P1-15-01: WithdrawnMetzger Filho O, Janiszewska M, Guo H, Yardley D, Mayer I, Spring L, Arteaga C, Wrabel E, DeMeo M, Freedman R, Tolaney S, Waks A, Bardia A, Parsons H, Partridge A, Mayer E, King T, Polyak K, Viale G, Winer E, Krop I. Abstract P1-15-01: Withdrawn. Cancer Research 2019, 79: p1-15-01-p1-15-01. DOI: 10.1158/1538-7445.sabcs18-p1-15-01.
Abstract P3-08-04: Transient state change, but not permanent subtype change, after HER2-targeted therapy for HER2-positive breast cancerTanioka M, Parker J, Henry L, Tolaney S, Dang C, Krop I, Harris L, Polley M, Berry D, Winer E, Carey L, Perou C. Abstract P3-08-04: Transient state change, but not permanent subtype change, after HER2-targeted therapy for HER2-positive breast cancer. Cancer Research 2019, 79: p3-08-04-p3-08-04. DOI: 10.1158/1538-7445.sabcs18-p3-08-04.
Abstract P4-04-02: Identifying ERBB-2 activating mutations (mts) in HER2 negative tumors for clinical trials – Impact of institute-wide genomic testing and trial matching on trial enrollment in clinical practiceExman P, Garrido-Castro A, Hughes M, Freedman R, Ma C, Bose R, Cerami E, Wagle N, Barroso-Sousa R, Fitz C, Lindeman N, MacConaill L, Bychkovsky B, Lloyd M, Mackichan C, Kumari P, Tolaney S, Krop I, Winer E, Dillon D, Lin N. Abstract P4-04-02: Identifying ERBB-2 activating mutations (mts) in HER2 negative tumors for clinical trials – Impact of institute-wide genomic testing and trial matching on trial enrollment in clinical practice. Cancer Research 2019, 79: p4-04-02-p4-04-02. DOI: 10.1158/1538-7445.sabcs18-p4-04-02.
Abstract P5-12-02: PTEN alterations and tumor mutational burden (TMB) as potential predictors of resistance or response to immune checkpoint inhibitors (ICI) in metastatic triple-negative breast cancer (mTNBC)Barroso-Sousa R, Tyekucheva S, Pernas-Simon S, Exman P, Jain E, Garrido-Castro A, Hughes M, Bychkovsky B, Di Lascio S, Umeton R, Files J, Lindeman N, MacConaill L, Hodi F, Krop I, Dillon D, Winer E, Wagle N, Lin N, Mittendorf E, Tolaney S. Abstract P5-12-02: PTEN alterations and tumor mutational burden (TMB) as potential predictors of resistance or response to immune checkpoint inhibitors (ICI) in metastatic triple-negative breast cancer (mTNBC). Cancer Research 2019, 79: p5-12-02-p5-12-02. DOI: 10.1158/1538-7445.sabcs18-p5-12-02.
Abstract PD1-05: Results from the phase Ib/II clinical trial of bazedoxifene and palbociclib in hormone receptor positive metastatic breast cancerJeselsohn R, Guo H, Rees R, Barry W, Barlett C, Tung N, Krop I, Brown M, Winer E. Abstract PD1-05: Results from the phase Ib/II clinical trial of bazedoxifene and palbociclib in hormone receptor positive metastatic breast cancer. Cancer Research 2019, 79: pd1-05-pd1-05. DOI: 10.1158/1538-7445.sabcs18-pd1-05.
Abstract PD9-01: Genomic alterations associated with loss of HR expression in metastatic breast cancerGarrido-Castro A, Hughes M, Cherniack A, Barroso-Sousa R, Bychkovsky B, Di Lascio S, Berger A, Mittendorf E, Files J, Guo H, Kumari P, Cerami E, Krop I, Wagle N, Lindeman N, MacConaill L, Dillon D, Winer E, Lin N. Abstract PD9-01: Genomic alterations associated with loss of HR expression in metastatic breast cancer. Cancer Research 2019, 79: pd9-01-pd9-01. DOI: 10.1158/1538-7445.sabcs18-pd9-01.
Abstract OT2-07-02: Trastuzumab deruxtecan (DS-8201a) vs investigator's choice of treatment in subjects with HER2-positive, unresectable and/or metastatic breast cancer who previously received T-DM1: A randomized, phase 3 studyAndré F, Shahidi J, Lee C, Wang K, Krop I. Abstract OT2-07-02: Trastuzumab deruxtecan (DS-8201a) vs investigator's choice of treatment in subjects with HER2-positive, unresectable and/or metastatic breast cancer who previously received T-DM1: A randomized, phase 3 study. Cancer Research 2019, 79: ot2-07-02-ot2-07-02. DOI: 10.1158/1538-7445.sabcs18-ot2-07-02.
Abstract P6-17-02: Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-low expressing breast cancer: Updated results of a large phase 1 studyModi S, Tsurutani J, Tamura K, Park H, Sagara Y, Murthy R, Iwata H, Krop I, Doi T, Redfern C, Moreno-Aspitia A, Redman R, Lee C, Sugihara M, Fujisaki Y, Takahashi S. Abstract P6-17-02: Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-low expressing breast cancer: Updated results of a large phase 1 study. Cancer Research 2019, 79: p6-17-02-p6-17-02. DOI: 10.1158/1538-7445.sabcs18-p6-17-02.
Abstract P6-17-06: Characterization, monitoring and management of interstitial lung disease in patients with metastatic breast cancer: Analysis of data available from multiple studies of DS-8201a, a HER2-targeted antibody drug conjugate with a topoisomerase I inhibitor payloadPowell C, Camidge D, Gemma A, Kusumoto M, Baba T, Kuwano K, Bankier A, Kiura K, Tamura K, Modi S, Tsurutani J, Doi T, Iwata H, Krop I, Zhang L, Jasmeet S, Saito K, Shahidi J, Yver A, Takahashi S. Abstract P6-17-06: Characterization, monitoring and management of interstitial lung disease in patients with metastatic breast cancer: Analysis of data available from multiple studies of DS-8201a, a HER2-targeted antibody drug conjugate with a topoisomerase I inhibitor payload. Cancer Research 2019, 79: p6-17-06-p6-17-06. DOI: 10.1158/1538-7445.sabcs18-p6-17-06.
Abstract P6-17-10: Dose justification for DS-8201a, a HER2-targeted antibody-drug conjugate, for HER2-positive breast cancer: Observed clinical data and exposure-response analysesTamura K, Modi S, Tsurutani J, Takahashi S, Krop I, Iwata H, Wada R, Yin O, Garimella T, Sugihara M, Zhang L, Lee C, Yver A, Baselga J. Abstract P6-17-10: Dose justification for DS-8201a, a HER2-targeted antibody-drug conjugate, for HER2-positive breast cancer: Observed clinical data and exposure-response analyses. Cancer Research 2019, 79: p6-17-10-p6-17-10. DOI: 10.1158/1538-7445.sabcs18-p6-17-10.
TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast CancerConnolly RM, Leal JP, Solnes L, Huang CY, Carpenter A, Gaffney K, Abramson V, Carey LA, Liu MC, Rimawi M, Specht J, Storniolo AM, Valero V, Vaklavas C, Krop IE, Winer EP, Camp M, Miller RS, Wolff AC, Cimino-Mathews A, Park BH, Wahl RL, Stearns V. TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.2018.78.7986. PMID: 30721110, PMCID: PMC6424139, DOI: 10.1200/jco.2018.78.7986.
Integrated Analysis of RNA and DNA from the Phase III Trial CALGB 40601 Identifies Predictors of Response to Trastuzumab-Based Neoadjuvant Chemotherapy in HER2-Positive Breast CancerTanioka M, Fan C, Parker JS, Hoadley KA, Hu Z, Li Y, Hyslop TM, Pitcher BN, Soloway MG, Spears PA, Henry LN, Tolaney S, Dang CT, Krop IE, Harris LN, Berry DA, Mardis ER, Winer EP, Hudis CA, Carey LA, Perou CM. Integrated Analysis of RNA and DNA from the Phase III Trial CALGB 40601 Identifies Predictors of Response to Trastuzumab-Based Neoadjuvant Chemotherapy in HER2-Positive Breast Cancer. Clinical Cancer Research 2018, 24: 5292-5304. PMID: 30037817, PMCID: PMC6214737, DOI: 10.1158/1078-0432.ccr-17-3431.
Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation studyMunster P, Krop IE, LoRusso P, Ma C, Siegel BA, Shields AF, Molnár I, Wickham TJ, Reynolds J, Campbell K, Hendriks BS, Adiwijaya BS, Geretti E, Moyo V, Miller KD. Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study. British Journal Of Cancer 2018, 119: 1086-1093. PMID: 30361524, PMCID: PMC6219487, DOI: 10.1038/s41416-018-0235-2.
SPS-3 A prognostic model integrating clinical data and gene signatures in phase III neoadjuvant trial CALGB 40601 (Alliance)Tanioka M, Parker J, Henry L, Tolaney S, Dang C, Krop I, Harris L, Hillman D, Polley M, Berry D, Winer E, Carey L, Perou C. SPS-3 A prognostic model integrating clinical data and gene signatures in phase III neoadjuvant trial CALGB 40601 (Alliance). Annals Of Oncology 2018, 29: vii50. DOI: 10.1093/annonc/mdy373.
369TiP PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + Anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC)Loibl S, Metzger O, Mandrekar S, Mundhenke C, Seiler S, Valagussa P, DeMichele A, Lim E, Tripathy D, Winer E, Huang C, Carey L, Francis P, Miller K, Goetz M, Prat A, Loi S, Krop I, Gianni L, Ciruelos E. 369TiP PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + Anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC). Annals Of Oncology 2018, 29: viii121. DOI: 10.1093/annonc/mdy272.357.
286PD Post-treatment biopsies show evidence of cell cycle arrest and immune cell infiltration into tumors of ladiratuzumab vedotin-treated advanced breast cancer patientsSpecht J, Pusztai L, Forero-Torres A, Mita M, Weise A, Krop I, Grosse-Wilde A, Wang Z, Li M, Hengel S, Garfin P, Means G, Onsum M, Modi S. 286PD Post-treatment biopsies show evidence of cell cycle arrest and immune cell infiltration into tumors of ladiratuzumab vedotin-treated advanced breast cancer patients. Annals Of Oncology 2018, 29: viii92. DOI: 10.1093/annonc/mdy272.278.
OA02.07 Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung CancerTsurutani J, Park H, Doi T, Modi S, Takahashi S, Nakagawa K, Krop I, Waqar S, Yoh K, Li B, Taira S, Jikoh T, Singh J, Sugihara M, Jänne P. OA02.07 Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung Cancer. Journal Of Thoracic Oncology 2018, 13: s324. DOI: 10.1016/j.jtho.2018.08.244.
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast CancerDickler MN, Saura C, Richards DA, Krop IE, Cervantes A, Bedard PL, Patel MR, Pusztai L, Oliveira M, Cardenas AK, Cui N, Wilson TR, Stout TJ, Wei MC, Hsu JY, Baselga J. Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer. Clinical Cancer Research 2018, 24: 4380-4387. PMID: 29793946, PMCID: PMC6139036, DOI: 10.1158/1078-0432.ccr-18-0613.
Abstract B04: CDK4/6 inhibition triggers an antitumor immune responseDeCristo M, Goel S, Watt A, BrinJones H, Sceneay J, Li B, Khan N, Ubellacker J, Xie S, Metzger-Filho O, Hoog J, Ellis M, Ma C, Ramm S, Krop I, Winer E, Roberts T, Kim H, Zhao J, McAllister S. Abstract B04: CDK4/6 inhibition triggers an antitumor immune response. Cancer Immunology Research 2018, 6: b04-b04. DOI: 10.1158/2326-6074.tumimm17-b04.
Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical TrialBorges VF, Ferrario C, Aucoin N, Falkson C, Khan Q, Krop I, Welch S, Conlin A, Chaves J, Bedard PL, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. JAMA Oncology 2018, 4: 1214-1220. PMID: 29955792, PMCID: PMC6143009, DOI: 10.1001/jamaoncol.2018.1812.
Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancerKuang Y, Siddiqui B, Hu J, Pun M, Cornwell M, Buchwalter G, Hughes ME, Wagle N, Kirschmeier P, Jänne PA, Paweletz CP, Lin NU, Krop IE, Barry WT, Winer EP, Brown M, Jeselsohn R. Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer. Npj Breast Cancer 2018, 4: 22. PMID: 30083595, PMCID: PMC6072793, DOI: 10.1038/s41523-018-0075-5.
4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) † † These guidelines were developed by the European School of Oncology (ESO) and the European Society for Medical Oncology (ESMO).Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, André F, Harbeck N, Lopez B, Barrios CH, Bergh J, Biganzoli L, Boers-Doets CB, Cardoso MJ, Carey LA, Cortés J, Curigliano G, Diéras V, Saghir N, Eniu A, Fallowfield L, Francis PA, Gelmon K, Johnston SRD, Kaufman B, Koppikar S, Krop IE, Mayer M, Nakigudde G, Offersen BV, Ohno S, Pagani O, Paluch-Shimon S, Penault-Llorca F, Prat A, Rugo HS, Sledge GW, Spence D, Thomssen C, Vorobiof DA, Xu B, Norton L, Winer EP. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) † † These guidelines were developed by the European School of Oncology (ESO) and the European Society for Medical Oncology (ESMO). Annals Of Oncology 2018, 29: 1634-1657. PMID: 30032243, PMCID: PMC7360146, DOI: 10.1093/annonc/mdy192.
Abstract 4564: The immune microenvironment in hormone receptor-positive breast cancer and treatment outcome following preoperative chemotherapy plus bevacizumabWaks A, Stover D, Barry W, Dillon D, Gjini E, Rodig S, Brock J, Baltay M, Savoie J, Winer E, Krop I, Tolaney S. Abstract 4564: The immune microenvironment in hormone receptor-positive breast cancer and treatment outcome following preoperative chemotherapy plus bevacizumab. Cancer Research 2018, 78: 4564-4564. DOI: 10.1158/1538-7445.am2018-4564.
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline UpdateGiordano SH, Temin S, Chandarlapaty S, Crews JR, Esteva FJ, Kirshner JJ, Krop IE, Levinson J, Lin NU, Modi S, Patt DA, Perlmutter J, Ramakrishna N, Winer EP, Davidson NE. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.269. PMID: 29939838, DOI: 10.1200/jco.2018.79.2697.
Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline UpdateRamakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Kirshner JJ, Krop IE, Levinson J, Modi S, Patt DA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.271. PMID: 29939840, DOI: 10.1200/jco.2018.79.2713.
Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA -mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER.Baselga J, Dent S, Cortés J, Im Y, Diéras V, Harbeck N, Krop I, Verma S, Wilson T, Jin H, Wang L, Schimmoller F, Hsu J, He J, DeLaurentiis M, Drullinsky P, Jacot W. Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA -mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER. Journal Of Clinical Oncology 2018, 36: lba1006-lba1006. DOI: 10.1200/jco.2018.36.18_suppl.lba1006.
Phase 1/1b dose escalation and expansion study of BEZ235, a dual PI3K/mTOR inhibitor, in patients with advanced solid tumors including patients with advanced breast cancerRodon J, Pérez-Fidalgo A, Krop IE, Burris H, Guerrero-Zotano A, Britten CD, Becerra C, Schellens J, Richards DA, Schuler M, Abu-Khalaf M, Johnson FM, Ranson M, Edenfield J, Silva AP, Hackl W, Quadt C, Demanse D, Duval V, Baselga J. Phase 1/1b dose escalation and expansion study of BEZ235, a dual PI3K/mTOR inhibitor, in patients with advanced solid tumors including patients with advanced breast cancer. Cancer Chemotherapy And Pharmacology 2018, 82: 285-298. PMID: 29882016, PMCID: PMC6286256, DOI: 10.1007/s00280-018-3610-z.
Results from molecular analysis for therapy choice (MATCH) arm I: Taselisib for PIK3CA-mutated tumors.Krop I, Jegede O, Grilley-Olson J, Lauring J, Hamilton S, Zwiebel J, Li S, Rubinstein L, Doyle A, Patton D, Mitchell E, Arteaga C, Conley B, Sims D, Harris L, Chen A, Flaherty K. Results from molecular analysis for therapy choice (MATCH) arm I: Taselisib for PIK3CA-mutated tumors. Journal Of Clinical Oncology 2018, 36: 101-101. DOI: 10.1200/jco.2018.36.15_suppl.101.
Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts.Iwata H, Tamura K, Doi T, Tsurutani J, Modi S, Park H, Krop I, Sagara Y, Redfern C, Murthy R, Redman R, Shitara K, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Yver A, Takahashi S. Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts. Journal Of Clinical Oncology 2018, 36: 2501-2501. DOI: 10.1200/jco.2018.36.15_suppl.2501.
HER2-enriched subtype and ERBB2 mRNA as predictors of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer: A combined analysis of TBCRC006/023 and PAMELA trials.Prat A, De Angelis C, Pascual T, Gutierrez C, Llombart-Cussac A, Wang T, Cortes J, Rexer B, Veeraraghavan J, Forero-Torres A, Wolff A, Morales S, Krop I, Pavlick A, Bermejo B, Hilsenbeck S, Oliveira M, Schiff R, Osborne C, Rimawi M. HER2-enriched subtype and ERBB2 mRNA as predictors of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer: A combined analysis of TBCRC006/023 and PAMELA trials. Journal Of Clinical Oncology 2018, 36: 509-509. DOI: 10.1200/jco.2018.36.15_suppl.509.
The tumor-immune microenvironment (TME) in HR+/HER2- metastatic breast cancer (mBC): Relationship to non-metastatic (met) tumors and prior treatment (tx) received.Waks A, Tolaney S, Schnitt S, Dillon D, Gjini E, Abdelrahman S, Marino-Enriquez A, Helvie K, Marini L, Cohen O, Kim D, Wander S, Stover D, Rodig S, Krop I, Winer E, Lin N, Wagle N. The tumor-immune microenvironment (TME) in HR+/HER2- metastatic breast cancer (mBC): Relationship to non-metastatic (met) tumors and prior treatment (tx) received. Journal Of Clinical Oncology 2018, 36: 1054-1054. DOI: 10.1200/jco.2018.36.15_suppl.1054.
A phase II study of atezolizumab (Atezo) combined with pertuzumab (P) and high-dose trastuzumab (H) for the treatment of central nervous system (CNS) metastases in patients with Her2-positive (HER2+) metastatic breast cancer (MBC).Barroso-Sousa R, Barry W, Kumthekar P, Guo H, Silvestri K, Krop I, Winer E, Tolaney S, Lin N. A phase II study of atezolizumab (Atezo) combined with pertuzumab (P) and high-dose trastuzumab (H) for the treatment of central nervous system (CNS) metastases in patients with Her2-positive (HER2+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2018, 36: tps1100-tps1100. DOI: 10.1200/jco.2018.36.15_suppl.tps1100.
A randomized phase II trial of carboplatin with or without nivolumab in first- or second-line metastatic TNBC.Garrido-Castro A, Barry W, Traina T, Wesolowski R, Tung N, Keenan T, Van Allen E, Lin N, Winer E, Krop I, Tolaney S. A randomized phase II trial of carboplatin with or without nivolumab in first- or second-line metastatic TNBC. Journal Of Clinical Oncology 2018, 36: tps1118-tps1118. DOI: 10.1200/jco.2018.36.15_suppl.tps1118.
Obesity promotes resistance to anti-VEGF therapy in breast cancer by up-regulating IL-6 and potentially FGF-2Incio J, Ligibel JA, McManus DT, Suboj P, Jung K, Kawaguchi K, Pinter M, Babykutty S, Chin SM, Vardam TD, Huang Y, Rahbari NN, Roberge S, Wang D, Gomes-Santos IL, Puchner SB, Schlett CL, Hoffmman U, Ancukiewicz M, Tolaney SM, Krop IE, Duda DG, Boucher Y, Fukumura D, Jain RK. Obesity promotes resistance to anti-VEGF therapy in breast cancer by up-regulating IL-6 and potentially FGF-2. Science Translational Medicine 2018, 10 PMID: 29540614, PMCID: PMC5936748, DOI: 10.1126/scitranslmed.aag0945.
Abstract PD3-14: Phase 1 study of the antibody-drug conjugate SGN-LIV1A in patients with heavily pretreated triple-negative metastatic breast cancerModi S, Pusztai L, Forero A, Mita M, Miller K, Weise A, Krop I, Burris H, Kalinsky K, Tsai M, Liu M, Hurvitz S, Wilks S, Ademuyiwa F, Diab S, Han H, Kato G, Nanda R, O'Shaughnessy J, Kostic A, Li M, Specht J. Abstract PD3-14: Phase 1 study of the antibody-drug conjugate SGN-LIV1A in patients with heavily pretreated triple-negative metastatic breast cancer. Cancer Research 2018, 78: pd3-14-pd3-14. DOI: 10.1158/1538-7445.sabcs17-pd3-14.
Abstract OT1-02-02: A phase II study of pembrolizumab in combination with palliative radiotherapy for metastatic hormone receptor positive breast cancerBarroso-Sousa R, Gao H, Barry W, Krop I, Schoenfeld J, Tolaney S. Abstract OT1-02-02: A phase II study of pembrolizumab in combination with palliative radiotherapy for metastatic hormone receptor positive breast cancer. Cancer Research 2018, 78: ot1-02-02-ot1-02-02. DOI: 10.1158/1538-7445.sabcs17-ot1-02-02.
Abstract P2-09-12: Independent validation of the HER2-enriched subtype as a predictor of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancerPrat A, De Angelis C, Pascual T, Gutierrez C, Wang T, Paré L, Rexer B, Cortes J, Forero A, Llombart A, Wolff A, Krop I, Galván P, Pavlick A, Villagrasa P, Hilsenbeck S, Schiff R, Osborne C, Rimawi M. Abstract P2-09-12: Independent validation of the HER2-enriched subtype as a predictor of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer. Cancer Research 2018, 78: p2-09-12-p2-09-12. DOI: 10.1158/1538-7445.sabcs17-p2-09-12.
Abstract P5-20-01: Prolonged progression-free survival (PFS) in advanced HER2+ metastatic breast cancer with or without brain metastases: A pooled analysis of tucatinib phase 1b studiesHamilton E, Murthy R, Ferrario C, Conlin A, Krop I, Falkson C, Khan Q, Chamberlain M, Gray T, Borges V. Abstract P5-20-01: Prolonged progression-free survival (PFS) in advanced HER2+ metastatic breast cancer with or without brain metastases: A pooled analysis of tucatinib phase 1b studies. Cancer Research 2018, 78: p5-20-01-p5-20-01. DOI: 10.1158/1538-7445.sabcs17-p5-20-01.
Abstract GS3-02: Invasive disease-free survival and gene expression signatures in CALGB (Alliance) 40601, a randomized phase III neoadjuvant trial of dual HER2-targeting with lapatinib added to chemotherapy plus trastuzumabKrop I, Hillman D, Polley M, Tanioka M, Parker J, Huebner L, Henry N, Tolaney S, Dang C, Harris L, Berry D, Perou C, Partridge A, Winer E, Carey L. Abstract GS3-02: Invasive disease-free survival and gene expression signatures in CALGB (Alliance) 40601, a randomized phase III neoadjuvant trial of dual HER2-targeting with lapatinib added to chemotherapy plus trastuzumab. Cancer Research 2018, 78: gs3-02-gs3-02. DOI: 10.1158/1538-7445.sabcs17-gs3-02.
Abstract GS3-07: Genome-wide copy number analysis of chemotherapy-resistant metastatic triple-negative breast cancer from cell-free DNAStover D, Parsons H, Ha G, Freeman S, Barry B, Guo H, Choudhury A, Gydush G, Reed S, Rhoades J, Rotem D, Hughes M, Dillon D, Partridge A, Wagle N, Krop I, Getz G, Golub T, Love J, Winer E, Tolaney S, Lin N, Adalsteinsson V. Abstract GS3-07: Genome-wide copy number analysis of chemotherapy-resistant metastatic triple-negative breast cancer from cell-free DNA. Cancer Research 2018, 78: gs3-07-gs3-07. DOI: 10.1158/1538-7445.sabcs17-gs3-07.
Abstract GS4-07: Results from a randomized placebo-controlled phase 2 trial evaluating exemestane ± enzalutamide in patients with hormone receptor–positive breast cancerKrop I, Abramson V, Colleoni M, Traina T, Holmes F, Estevez L, Hart L, Awada A, Zamagni C, Morris P, Schwartzberg L, Chan S, Wheatley D, Gucalp A, Biganzoli L, Steinberg J, Gianni L, Trudeau M, Tudor I, Markova D, Barry E, Tarazi J, Stewart R, Winer E, Yardley D. Abstract GS4-07: Results from a randomized placebo-controlled phase 2 trial evaluating exemestane ± enzalutamide in patients with hormone receptor–positive breast cancer. Cancer Research 2018, 78: gs4-07-gs4-07. DOI: 10.1158/1538-7445.sabcs17-gs4-07.
Abstract OT3-05-07: PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2 positive metastatic breast cancerMetzger-Filho O, Mandrekar S, Loibl S, Ciruelos E, Gianni L, Lim E, Miller K, Huang C, Koehler M, Francis P, Valagussa P, Goel S, Prat A, Goetz M, Loi S, Krop I, Carey L, Lanzillotti J, Winer E, Tripathy D, DeMichele A. Abstract OT3-05-07: PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2 positive metastatic breast cancer. Cancer Research 2018, 78: ot3-05-07-ot3-05-07. DOI: 10.1158/1538-7445.sabcs17-ot3-05-07.
Abstract PD3-01: Immune profile of small HER2+ tumors in the APT trialTolaney S, Barry W, Guo H, Dillon D, Tan Y, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom K, Krop I, Winer E. Abstract PD3-01: Immune profile of small HER2+ tumors in the APT trial. Cancer Research 2018, 78: pd3-01-pd3-01. DOI: 10.1158/1538-7445.sabcs17-pd3-01.
Abstract PD6-09: The immune microenvironment in hormone receptor-positive breast cancer patients and relationship to treatment outcome following preoperative chemotherapy plus bevacizumabWaks A, Stover D, Barry W, Dillon D, Gjini E, Rodig S, Brock J, Baltay M, Savoie J, Winer E, Krop I, Tolaney S. Abstract PD6-09: The immune microenvironment in hormone receptor-positive breast cancer patients and relationship to treatment outcome following preoperative chemotherapy plus bevacizumab. Cancer Research 2018, 78: pd6-09-pd6-09. DOI: 10.1158/1538-7445.sabcs17-pd6-09.
Incidence of Endocrine Dysfunction Following the Use of Different Immune Checkpoint Inhibitor Regimens: A Systematic Review and Meta-analysisBarroso-Sousa R, Barry WT, Garrido-Castro AC, Hodi FS, Min L, Krop IE, Tolaney SM. Incidence of Endocrine Dysfunction Following the Use of Different Immune Checkpoint Inhibitor Regimens: A Systematic Review and Meta-analysis. JAMA Oncology 2018, 4: 173-182. PMID: 28973656, PMCID: PMC5838579, DOI: 10.1001/jamaoncol.2017.3064.
Association of Cell-Free DNA Tumor Fraction and Somatic Copy Number Alterations With Survival in Metastatic Triple-Negative Breast CancerStover DG, Parsons HA, Ha G, Freeman SS, Barry WT, Guo H, Choudhury AD, Gydush G, Reed SC, Rhoades J, Rotem D, Hughes ME, Dillon DA, Partridge AH, Wagle N, Krop IE, Getz G, Golub TR, Love JC, Winer EP, Tolaney SM, Lin NU, Adalsteinsson VA. Association of Cell-Free DNA Tumor Fraction and Somatic Copy Number Alterations With Survival in Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2018, 36: jco.2017.76.003. PMID: 29298117, PMCID: PMC5815405, DOI: 10.1200/jco.2017.76.0033.
Reply to J.L. Blum et al and S. Lange et alKrop I, Ismaila N, Barlow W, Stearns V. Reply to J.L. Blum et al and S. Lange et al. Journal Of Clinical Oncology 2017, 36: jco.2017.75.860. PMID: 29227726, DOI: 10.1200/jco.2017.75.8607.
Low PTEN levels and PIK3CA mutations predict resistance to neoadjuvant lapatinib and trastuzumab without chemotherapy in patients with HER2 over-expressing breast cancerRimawi MF, De Angelis C, Contreras A, Pareja F, Geyer FC, Burke KA, Herrera S, Wang T, Mayer IA, Forero A, Nanda R, Goetz MP, Chang JC, Krop IE, Wolff AC, Pavlick AC, Fuqua SAW, Gutierrez C, Hilsenbeck SG, Li MM, Weigelt B, Reis-Filho JS, Kent Osborne C, Schiff R. Low PTEN levels and PIK3CA mutations predict resistance to neoadjuvant lapatinib and trastuzumab without chemotherapy in patients with HER2 over-expressing breast cancer. Breast Cancer Research And Treatment 2017, 167: 731-740. PMID: 29110152, PMCID: PMC5821069, DOI: 10.1007/s10549-017-4533-9.
CMET-25. PROGRESSION-FREE SURVIVAL (PFS) AND SITE OF FIRST PROGRESSION IN HER2+ METASTATIC BREAST CANCER PATIENTS WITH OR WITHOUT BRAIN METASTASES: A POOLED ANALYSIS OF TUCATINIB PHASE I STUDIESHamilton E, Moulder S, Ferrario C, Conlin A, Krop I, Chamberlain M, Gray T, Borges V. CMET-25. PROGRESSION-FREE SURVIVAL (PFS) AND SITE OF FIRST PROGRESSION IN HER2+ METASTATIC BREAST CANCER PATIENTS WITH OR WITHOUT BRAIN METASTASES: A POOLED ANALYSIS OF TUCATINIB PHASE I STUDIES. Neuro-Oncology 2017, 19: vi44-vi44. PMCID: PMC5692086, DOI: 10.1093/neuonc/nox168.173.
IN06 Optimal Sequence with and without Therapies for ABCKrop I. IN06 Optimal Sequence with and without Therapies for ABC. The Breast 2017, 36: s20. DOI: 10.1016/s0960-9776(17)30626-4.
264P Progression-free survival (PFS) and site of first progression in HER2+ metastatic breast cancer (MBC) patients (pts) with (w) or without (w/o) brain metastases: A pooled analysis of tucatinib phase I studiesMoulder S, Hamilton E, Ferrario C, Conlin A, Krop I, Chamberlain M, Gray T, Borges V. 264P Progression-free survival (PFS) and site of first progression in HER2+ metastatic breast cancer (MBC) patients (pts) with (w) or without (w/o) brain metastases: A pooled analysis of tucatinib phase I studies. Annals Of Oncology 2017, 28: v85. DOI: 10.1093/annonc/mdx365.027.
324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancerMetzger O, Mandrekar S, Ciruelos E, Loibl S, Valagussa P, Demichele A, Lim E, Tripathy D, Winer E, Huang C, Khoeler M, Carey L, Francis P, Miller K, Goel S, Goetz M, Prat A, Loi S, Krop I, Gianni L. 324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer. Annals Of Oncology 2017, 28: v107-v108. DOI: 10.1093/annonc/mdx365.087.
CDK4/6 inhibition triggers anti-tumour immunityGoel S, DeCristo MJ, Watt AC, BrinJones H, Sceneay J, Li BB, Khan N, Ubellacker JM, Xie S, Metzger-Filho O, Hoog J, Ellis MJ, Ma CX, Ramm S, Krop IE, Winer EP, Roberts TM, Kim HJ, McAllister SS, Zhao JJ. CDK4/6 inhibition triggers anti-tumour immunity. Nature 2017, 548: 471-475. PMID: 28813415, PMCID: PMC5570667, DOI: 10.1038/nature23465.
64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast CancerLee H, Shields AF, Siegel BA, Miller KD, Krop I, X. C, LoRusso PM, Munster PN, Campbell K, Gaddy DF, Leonard SC, Geretti E, Blocker SJ, Kirpotin DB, Moyo V, Wickham TJ, Hendriks BS. 64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer. Clinical Cancer Research 2017, 23: 4190-4202. PMID: 28298546, PMCID: PMC6790129, DOI: 10.1158/1078-0432.ccr-16-3193.
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update Guideline SummaryKrop I, Ismaila N, Stearns V. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update Guideline Summary. JCO Oncology Practice 2017, 13: jop.2017.024646. PMID: 28696818, DOI: 10.1200/jop.2017.024646.
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused UpdateKrop I, Ismaila N, Andre F, Bast RC, Barlow W, Collyar DE, Hammond ME, Kuderer NM, Liu MC, Mennel RG, Van Poznak C, Wolff AC, Stearns V. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. Journal Of Clinical Oncology 2017, 35: jco.2017.74.047. PMID: 28692382, PMCID: PMC5846188, DOI: 10.1200/jco.2017.74.0472.
Abstract 4950: The emergence of ESR1 mutations is associated with aromatase inhibitor and fulvestrant therapyKuang Y, Siddiqui B, Hu J, Barry W, Lin N, Wagle N, Kirschmeier P, Jänne P, Paweletz C, Krop I, Winer E, Brown M, Jeselsohn R. Abstract 4950: The emergence of ESR1 mutations is associated with aromatase inhibitor and fulvestrant therapy. Cancer Research 2017, 77: 4950-4950. DOI: 10.1158/1538-7445.am2017-4950.
Abstract CT055: A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC) (HER2CLIMB)Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pivot X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. Abstract CT055: A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC) (HER2CLIMB). Cancer Research 2017, 77: ct055-ct055. DOI: 10.1158/1538-7445.am2017-ct055.
Phase I Dose-Escalation Study of Taselisib, an Oral PI3K Inhibitor, in Patients with Advanced Solid TumorsJuric D, Krop I, Ramanathan RK, Wilson TR, Ware JA, Bohorquez S, Savage HM, Sampath D, Salphati L, Lin RS, Jin H, Parmar H, Hsu JY, Von Hoff DD, Baselga J. Phase I Dose-Escalation Study of Taselisib, an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors. Cancer Discovery 2017, 7: 704-715. PMID: 28331003, PMCID: PMC5501742, DOI: 10.1158/2159-8290.cd-16-1080.
Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer (BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev).Waks A, Barry W, Gjini E, Dillon D, Rodig S, Brock J, Baltay M, Savoie J, Stover D, Winer E, Krop I, Tolaney S. Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer (BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev). Journal Of Clinical Oncology 2017, 35: e12134-e12134. DOI: 10.1200/jco.2017.35.15_suppl.e12134.
A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB).Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pivot X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB). Journal Of Clinical Oncology 2017, 35: tps1107-tps1107. DOI: 10.1200/jco.2017.35.15_suppl.tps1107.
TBCRC 036: Window of opportunity clinical trial reveals adaptive kinome reprogramming in single and combination HER2-targeting in breast cancer (BrCa).Angus S, Stuhlmiller T, Sciaky N, Chen X, Naim R, Tanioka M, Gallagher K, Forero A, Krop I, Thompson A, Murthy R, He X, Perou C, Earp S, Carey L, Johnson G. TBCRC 036: Window of opportunity clinical trial reveals adaptive kinome reprogramming in single and combination HER2-targeting in breast cancer (BrCa). Journal Of Clinical Oncology 2017, 35: 1027-1027. DOI: 10.1200/jco.2017.35.15_suppl.1027.
A phase I study of PF-06647263, a novel EFNA4-ADC, in patients with metastatic triple negative breast cancer.Garrido-Laguna I, Krop I, Burris H, Hamilton E, Braiteh F, Weise A, Abu-Khalaf M, Zopf C, Lakshminarayanan M, Holland J, Baffa R, Hong D, Hassan R. A phase I study of PF-06647263, a novel EFNA4-ADC, in patients with metastatic triple negative breast cancer. Journal Of Clinical Oncology 2017, 35: 2511-2511. DOI: 10.1200/jco.2017.35.15_suppl.2511.
Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial.Spring L, Goel S, Juric D, Isakoff S, Haddad S, Habin K, Krop I, Moy B, Tolaney S, Bardia A. Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial. Journal Of Clinical Oncology 2017, 35: tps1106-tps1106. DOI: 10.1200/jco.2017.35.15_suppl.tps1106.
SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA- mutant tumors.Baselga J, Cortés J, DeLaurentiis M, Dent S, Diéras V, Harbeck N, Hsu J, Jin H, Schimmoller F, Wilson T, Im Y, Jacot W, Krop I, Verma S. SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA- mutant tumors. Journal Of Clinical Oncology 2017, 35: tps1119-tps1119. DOI: 10.1200/jco.2017.35.15_suppl.tps1119.
TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM).Freedman R, Gelman R, Melisko M, Anders C, Moy B, Blackwell K, Connolly R, Niravath P, Van Poznak C, Puhalla S, Farooq S, Cropp A, Cotter C, Liu M, Krop I, Nangia J, Tung N, Wolff A, Winer E, Lin N. TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM). Journal Of Clinical Oncology 2017, 35: 1005-1005. DOI: 10.1200/jco.2017.35.15_suppl.1005.
A mouse-human phase I co-clinical trial of taselisib in combination with TDM1 in advanced HER2-positive breast cancer (MBC).Metzger Filho O, Goel S, Barry W, Hamilton E, Tolaney S, Yardley D, Rees R, Demeo M, Mills C, Hafner M, Winer E, Zhao J, Krop I. A mouse-human phase I co-clinical trial of taselisib in combination with TDM1 in advanced HER2-positive breast cancer (MBC). Journal Of Clinical Oncology 2017, 35: 1030-1030. DOI: 10.1200/jco.2017.35.15_suppl.1030.
A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).Luis I, Guo H, Barry W, Krop I, Wagle N, Lowe A, Gore D, Andrews C, Osmani W, Isakoff S, Tung N, Winer E, Lin N, Freedman R. A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2017, 35: 1034-1034. DOI: 10.1200/jco.2017.35.15_suppl.1034.
Genome-wide copy number analysis of cell-free DNA from patients with chemotherapy-resistant metastatic triple-negative breast cancer.Stover D, Parsons H, Ha G, Freeman S, Barry W, Guo H, Gydush G, Reed S, Rhoades J, Rotem D, Hughes M, Krop I, Tolaney S, Wagle N, Getz G, Meyerson M, Love J, Winer E, Lin N, Adalsteinsson V. Genome-wide copy number analysis of cell-free DNA from patients with chemotherapy-resistant metastatic triple-negative breast cancer. Journal Of Clinical Oncology 2017, 35: 1092-1092. DOI: 10.1200/jco.2017.35.15_suppl.1092.
Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).Tolaney S, Barry W, Guo H, Dillon D, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Overmoyer B, Partridge A, Hudis C, Krop I, Burstein H, Winer E. Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Journal Of Clinical Oncology 2017, 35: 511-511. DOI: 10.1200/jco.2017.35.15_suppl.511.
Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trialDiéras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. The Lancet Oncology 2017, 18: 732-742. PMID: 28526536, PMCID: PMC5531181, DOI: 10.1016/s1470-2045(17)30312-1.
Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trialKrop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. The Lancet Oncology 2017, 18: 743-754. PMID: 28526538, DOI: 10.1016/s1470-2045(17)30313-3.
Abstract OT2-01-01: SANDPIPER: Phase III study of the PI3-kinase inhibitor taselisib (GDC-0032) plus fulvestrant in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer enriched for patients with PIK3CA- mutant tumorsBaselga J, Cortés J, De Laurentiis M, Dent S, Diéras V, Harbeck N, Hsu J, Jin H, Schimmoller F, Wilson T, Im Y, Jacot W, Krop I, Verma S. Abstract OT2-01-01: SANDPIPER: Phase III study of the PI3-kinase inhibitor taselisib (GDC-0032) plus fulvestrant in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer enriched for patients with PIK3CA- mutant tumors. Cancer Research 2017, 77: ot2-01-01-ot2-01-01. DOI: 10.1158/1538-7445.sabcs16-ot2-01-01.
Abstract P1-01-01: Circulating tumor cell number and CTC-endocrine therapy index predict clinical outcomes in ER positive metastatic breast cancer patients: Results of the COMETI Phase 2 trialPaoletti C, Regan M, Liu M, Marcom P, Hart L, Smith J, Tedesco K, Amir E, Krop I, DeMichele A, Goodwin P, Block M, Aung K, Cannell E, Darga E, Baratta P, Brown M, McCormack R, Hayes D. Abstract P1-01-01: Circulating tumor cell number and CTC-endocrine therapy index predict clinical outcomes in ER positive metastatic breast cancer patients: Results of the COMETI Phase 2 trial. Cancer Research 2017, 77: p1-01-01-p1-01-01. DOI: 10.1158/1538-7445.sabcs16-p1-01-01.
Abstract P4-22-08: A single-arm phase 2 study to assess clinical activity, efficacy and safety of enzalutamide with trastuzumab in HER2+ AR+ metastatic or locally advanced breast cancerKrop I, Cortes J, Miller K, Huizing M, Provencher L, Gianni L, Chan S, Trudeau M, Steinberg J, Sugg J, Liosatos M, Paton V, Peterson A, Wardley A. Abstract P4-22-08: A single-arm phase 2 study to assess clinical activity, efficacy and safety of enzalutamide with trastuzumab in HER2+ AR+ metastatic or locally advanced breast cancer. Cancer Research 2017, 77: p4-22-08-p4-22-08. DOI: 10.1158/1538-7445.sabcs16-p4-22-08.
Abstract P6-12-01: Phase II study of taselisib (GDC-0032) plus fulvestrant in HER2-negative, hormone receptor-positive advanced breast cancer: Analysis by PIK3CA and ESR1 mutation status from circulating tumor DNADickler M, Saura C, Oliveira M, Richards D, Krop I, Cervantes A, Stout T, Jin H, Savage H, Wilson T, Baselga J. Abstract P6-12-01: Phase II study of taselisib (GDC-0032) plus fulvestrant in HER2-negative, hormone receptor-positive advanced breast cancer: Analysis by PIK3CA and ESR1 mutation status from circulating tumor DNA. Cancer Research 2017, 77: p6-12-01-p6-12-01. DOI: 10.1158/1538-7445.sabcs16-p6-12-01.
Abstract P6-12-04: Phase 1 study of the antibody-drug conjugate (ADC) SGN-LIV1A in patients with heavily pretreated metastatic breast cancerForero-Torres A, Modi S, Specht J, Miller K, Weise A, Burris H, Liu M, Krop I, Pusztai L, Kostic A, Li M, Mita M. Abstract P6-12-04: Phase 1 study of the antibody-drug conjugate (ADC) SGN-LIV1A in patients with heavily pretreated metastatic breast cancer. Cancer Research 2017, 77: p6-12-04-p6-12-04. DOI: 10.1158/1538-7445.sabcs16-p6-12-04.
Abstract P4-21-40: In vitro and in vivo activity of HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 in HER2-intermediate tumorsGeretti E, Espelin C, Adiwijaya B, Coma S, Koncki Z, Sumner P, Dumont N, Garcia G, Bloom T, Janovsky J, Reynolds J, Campbell K, Moyo V, Molnar I, LoRusso P, Krop I, Miller K, Ma C, Munster P, Wickham T. Abstract P4-21-40: In vitro and in vivo activity of HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 in HER2-intermediate tumors. Cancer Research 2017, 77: p4-21-40-p4-21-40. DOI: 10.1158/1538-7445.sabcs16-p4-21-40.
Abstract OT1-02-09: A phase 2 randomized, double-blinded, controlled study of ONT-380 vs. placebo in combination with capecitabine (C) and trastuzumab (T) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC) (HER2CLIMB)Hamilton E, Borges V, Murthy R, Anders C, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagy G, Krop I, Loibl S, Pivort X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. Abstract OT1-02-09: A phase 2 randomized, double-blinded, controlled study of ONT-380 vs. placebo in combination with capecitabine (C) and trastuzumab (T) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC) (HER2CLIMB). Cancer Research 2017, 77: ot1-02-09-ot1-02-09. DOI: 10.1158/1538-7445.sabcs16-ot1-02-09.
Abstract P1-12-04: Phase I dose-escalation trial of ONT-380 in combination with trastuzumab in patients (pts) with HER2+ breast cancer brain metastasesMetzger O, Barry W, Krop I, Guo H, Younger J, Lawler E, Walker L, Freedman R, Tolaney S, Winer E, Lin N. Abstract P1-12-04: Phase I dose-escalation trial of ONT-380 in combination with trastuzumab in patients (pts) with HER2+ breast cancer brain metastases. Cancer Research 2017, 77: p1-12-04-p1-12-04. DOI: 10.1158/1538-7445.sabcs16-p1-12-04.
Abstract P2-08-01: Results from a randomized placebo-controlled phase 2 trial evaluating exemestane ± enzalutamide in patients with hormone receptor–positive breast cancerKrop I, Abramson V, Colleoni M, Holmes F, Estevez L, Hart L, Awada A, Zamagni C, Morris P, Schwartzberg L, Chan S, Wheatley D, Guculp A, Biganzoli L, Steinberg J, Gianni L, Trudeau M, Kelly C, Uppal H, Tudor I, Peterson A, Winer E, Yardley D. Abstract P2-08-01: Results from a randomized placebo-controlled phase 2 trial evaluating exemestane ± enzalutamide in patients with hormone receptor–positive breast cancer. Cancer Research 2017, 77: p2-08-01-p2-08-01. DOI: 10.1158/1538-7445.sabcs16-p2-08-01.
Abstract S1-01: Whole exome and transcriptome sequencing of resistant ER+ metastatic breast cancerCohen O, Kim D, Oh C, Waks A, Oliver N, Helvie K, Marini L, Rotem A, Lloyd M, Stover D, Adalsteinsson V, Freeman S, Ha G, Cibulskis C, Anderka K, Tamayo P, Johannessen C, Krop I, Garraway L, Winer E, Lin N, Wagle N. Abstract S1-01: Whole exome and transcriptome sequencing of resistant ER+ metastatic breast cancer. Cancer Research 2017, 77: s1-01-s1-01. DOI: 10.1158/1538-7445.sabcs16-s1-01.
Abstract S3-05: Integrated analysis of multidimensional genomic data on CALGB 40601 (Alliance), a randomized neoadjuvant phase III trial of weekly paclitaxel (T) and trastuzumab (H) with or without lapatinib (L) for HER2-positive breast cancerTanioka M, Fan C, Carey L, Hyslop T, Pitcher B, Parker J, Hoadley K, Henry N, Tolaney S, Dang C, Krop I, Harris L, Berry D, Mardis E, Perou C, Winer E, Hudis C. Abstract S3-05: Integrated analysis of multidimensional genomic data on CALGB 40601 (Alliance), a randomized neoadjuvant phase III trial of weekly paclitaxel (T) and trastuzumab (H) with or without lapatinib (L) for HER2-positive breast cancer. Cancer Research 2017, 77: s3-05-s3-05. DOI: 10.1158/1538-7445.sabcs16-s3-05.
Corrigendum to “3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 3)” [Breast 31 (February 2017) 244–259]Cardoso F, Costa A, Senkus E, Aapro M, André F, Barrios C, Bergh J, Bhattacharyya G, Biganzoli L, Cardoso M, Carey L, Corneliussen-James D, Curigliano G, Dieras V, Saghir N, Eniu A, Fallowfield L, Fenech D, Francis P, Gelmon K, Gennari A, Harbeck N, Hudis C, Kaufman B, Krop I, Mayer M, Meijer H, Mertz S, Ohno S, Pagani O, Papadopoulos E, Peccatori F, Penault-Llorca F, Piccart M, Pierga J, Rugo H, Shockney L, Sledge G, Swain S, Thomssen C, Tutt A, Vorobiof D, Xu B, Norton L, Winer E. Corrigendum to “3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 3)” [Breast 31 (February 2017) 244–259]. The Breast 2017, 32: 269-270. PMID: 28109648, DOI: 10.1016/j.breast.2017.01.001.
3rd ESO–ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3)Cardoso F, Costa A, Senkus E, Aapro M, André F, Barrios C, Bergh J, Bhattacharyya G, Biganzoli L, Cardoso M, Carey L, Corneliussen-James D, Curigliano G, Dieras V, Saghir N, Eniu A, Fallowfield L, Fenech D, Francis P, Gelmon K, Gennari A, Harbeck N, Hudis C, Kaufman B, Krop I, Mayer M, Meijer H, Mertz S, Ohno S, Pagani O, Papadopoulos E, Peccatori F, Pernault-Llorca F, Piccart M, Pierga J, Rugo H, Shockney L, Sledge G, Swain S, Thomssen C, Tutt A, Vorobiof D, Xu B, Norton L, Winer E. 3rd ESO–ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3). The Breast 2016, 31: 244-259. PMID: 27927580, DOI: 10.1016/j.breast.2016.10.001.
3rd ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3)Cardoso F, Costa A, Senkus E, Aapro M, André F, Barrios C, Bergh J, Bhattacharyya G, Biganzoli L, Cardoso M, Carey L, Corneliussen-James D, Curigliano G, Dieras V, Saghir N, Eniu A, Fallowfield L, Fenech D, Francis P, Gelmon K, Gennari A, Harbeck N, Hudis C, Kaufman B, Krop I, Mayer M, Meijer H, Mertz S, Ohno S, Pagani O, Papadopoulos E, Peccatori F, Penault-Llorca F, Piccart M, Pierga J, Rugo H, Shockney L, Sledge G, Swain S, Thomssen C, Tutt A, Vorobiof D, Xu B, Norton L, Winer E. 3rd ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3). Annals Of Oncology 2016, 28: 16-33. PMID: 28177437, PMCID: PMC5378224, DOI: 10.1093/annonc/mdw544.
313TiP SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA-mutant tumoursBaselga J, Castan J, De Laurentiis M, Dieras V, Harbeck N, Hsu J, Jin H, Schimmoller F, Wilson T, Im Y, Jacot W, Krop I, Verma S. 313TiP SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA-mutant tumours. Annals Of Oncology 2016, 27: vi99. DOI: 10.1093/annonc/mdw365.92.
315TiP HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and T-DM1Castan J, Verma S, Hurvitz S, Krop I, Tripathy D, Yardley D, Dionne M, Reynolds J, Wickham T, Molnar I, Miller K. 315TiP HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and T-DM1. Annals Of Oncology 2016, 27: vi99. DOI: 10.1093/annonc/mdw365.94.
1560P Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumorsGeretti E, Espelin C, Adiwijaya B, Dumont N, Coma S, Koncki Z, Garcia G, Bloom T, Rimkunas V, Reynolds J, Campbell K, Moyo V, Molnar I, Lorusso P, Miller K, Ma C, Krop I, Munster P, Wickham T. 1560P Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumors. Annals Of Oncology 2016, 27: vi539. DOI: 10.1093/annonc/mdw392.41.
Relationship between tumor biomarkers and efficacy in TH3RESA, a phase III study of trastuzumab emtansine (T‐DM1) vs. treatment of physician's choice in previously treated HER2‐positive advanced breast cancerKim S, Wildiers H, Krop IE, Smitt M, Yu R, de Haas S, Gonzalez‐Martin A. Relationship between tumor biomarkers and efficacy in TH3RESA, a phase III study of trastuzumab emtansine (T‐DM1) vs. treatment of physician's choice in previously treated HER2‐positive advanced breast cancer. International Journal Of Cancer 2016, 139: 2336-2342. PMID: 27428671, DOI: 10.1002/ijc.30276.
Abstract LB-061: HER2-targeted PEGylated liposomal doxorubicin (MM-302) efficiently targets the HER2 intermediate cell population in vitro and in vivoGeretti E, Espelin C, Adiwijaya B, Dumont N, Coma S, Koncki Z, Pham M, Garcia G, Bloom T, Rimkunas V, Reynolds J, Campbell K, Moyo V, Molnar I, LoRusso P, Krop I, Miller K, Ma C, Munster P, Wickham T. Abstract LB-061: HER2-targeted PEGylated liposomal doxorubicin (MM-302) efficiently targets the HER2 intermediate cell population in vitro and in vivo. Cancer Research 2016, 76: lb-061-lb-061. DOI: 10.1158/1538-7445.am2016-lb-061.
Immune Signatures Following Single Dose Trastuzumab Predict Pathologic Response to PreoperativeTrastuzumab and Chemotherapy in HER2-Positive Early Breast CancerVaradan V, Gilmore H, Miskimen KL, Tuck D, Parsai S, Awadallah A, Krop IE, Winer EP, Bossuyt V, Somlo G, Abu-Khalaf MM, Fenton MA, Sikov W, Harris L. Immune Signatures Following Single Dose Trastuzumab Predict Pathologic Response to PreoperativeTrastuzumab and Chemotherapy in HER2-Positive Early Breast Cancer. Clinical Cancer Research 2016, 22: 3249-3259. PMID: 26842237, PMCID: PMC5439498, DOI: 10.1158/1078-0432.ccr-15-2021.
PIK3CA mutations in HER2-positive breast cancer: an ongoing conundrumGoel S, Krop IE. PIK3CA mutations in HER2-positive breast cancer: an ongoing conundrum. Annals Of Oncology 2016, 27: 1368-1372. PMID: 27358378, DOI: 10.1093/annonc/mdw246.
PlGF/VEGFR-1 Signaling Promotes Macrophage Polarization and Accelerated Tumor Progression in ObesityIncio J, Tam J, Rahbari NN, Suboj P, McManus DT, Chin SM, Vardam TD, Batista A, Babykutty S, Jung K, Khachatryan A, Hato T, Ligibel JA, Krop IE, Puchner SB, Schlett CL, Hoffmman U, Ancukiewicz M, Shibuya M, Carmeliet P, Soares R, Duda DG, Jain RK, Fukumura D. PlGF/VEGFR-1 Signaling Promotes Macrophage Polarization and Accelerated Tumor Progression in Obesity. Clinical Cancer Research 2016, 22: 2993-3004. PMID: 26861455, PMCID: PMC4911258, DOI: 10.1158/1078-0432.ccr-15-1839.
Combination inhibition of PI3K and mTORC1 yields durable remissions in mice bearing orthotopic patient-derived xenografts of HER2-positive breast cancer brain metastasesNi J, Ramkissoon SH, Xie S, Goel S, Stover DG, Guo H, Luu V, Marco E, Ramkissoon LA, Kang YJ, Hayashi M, Nguyen QD, Ligon AH, Du R, Claus EB, Alexander BM, Yuan GC, Wang ZC, Iglehart JD, Krop IE, Roberts TM, Winer EP, Lin NU, Ligon KL, Zhao JJ. Combination inhibition of PI3K and mTORC1 yields durable remissions in mice bearing orthotopic patient-derived xenografts of HER2-positive breast cancer brain metastases. Nature Medicine 2016, 22: 723-726. PMID: 27270588, PMCID: PMC4938731, DOI: 10.1038/nm.4120.
HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancerMiller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer 2016, 16: 352. PMID: 27259714, PMCID: PMC4893300, DOI: 10.1186/s12885-016-2385-z.
Efficacy results of a phase 1b study of ONT-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases.Borges V, Ferrario C, Aucoin N, Falkson C, Khan Q, Krop I, Welch S, Bedard P, Conlin A, Chaves J, Walker L, Hamilton E. Efficacy results of a phase 1b study of ONT-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases. Journal Of Clinical Oncology 2016, 34: 513-513. DOI: 10.1200/jco.2016.34.15_suppl.513.
A phase II study of the PI3K inhibitor taselisib (GDC-0032) combined with fulvestrant (F) in patients (pts) with HER2-negative (HER2-), hormone receptor-positive (HR+) advanced breast cancer (BC).Dickler M, Saura C, Richards D, Krop I, Cervantes A, Bedard P, Patel M, Pusztai L, Oliveira M, Ware J, Jin H, Wilson T, Stout T, Wei M, Hsu J, Baselga J. A phase II study of the PI3K inhibitor taselisib (GDC-0032) combined with fulvestrant (F) in patients (pts) with HER2-negative (HER2-), hormone receptor-positive (HR+) advanced breast cancer (BC). Journal Of Clinical Oncology 2016, 34: 520-520. DOI: 10.1200/jco.2016.34.15_suppl.520.
SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA- mutant tumors.Baselga J, Cortes J, De Laurentiis M, Dieras V, Harbeck N, Hsu J, Ng V, Schimmoller F, Wilson T, Im Y, Jacot W, Krop I, Verma S. SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA- mutant tumors. Journal Of Clinical Oncology 2016, 34: tps617-tps617. DOI: 10.1200/jco.2016.34.15_suppl.tps617.
HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1).Miller K, Cortes J, Hurvitz S, Krop I, Tripathy D, Verma S, Dionne M, Campbell K, Reynolds J, Wickham T, Molnar I, Yardley D. HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1). Journal Of Clinical Oncology 2016, 34: tps631-tps631. DOI: 10.1200/jco.2016.34.15_suppl.tps631.
A cancer precision medicine platform for multiple simultaneous genomic assays from metastatic biopsies (bx) in ER+ metastatic breast cancer.Wagle N, Helvie K, Lloyd M, Marini L, Waks A, Cohen O, Oh C, Sougnez C, Oliver N, Quartey Q, Rotem A, Shah P, Lindeman N, Krop I, Garraway L, Winer E, Lin N. A cancer precision medicine platform for multiple simultaneous genomic assays from metastatic biopsies (bx) in ER+ metastatic breast cancer. Journal Of Clinical Oncology 2016, 34: 11513-11513. DOI: 10.1200/jco.2016.34.15_suppl.11513.
Mechanisms of resistance (MoR) to DNA damaging therapy (tx) in BRCA1/2-deficient (d) metastatic breast cancer (MBC).Waks A, Cohen O, Helvie K, Lloyd M, Marini L, Oh C, Oliver N, Lindeman N, Matulonis U, Krop I, Garraway L, Winer E, Lin N, Wagle N. Mechanisms of resistance (MoR) to DNA damaging therapy (tx) in BRCA1/2-deficient (d) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2016, 34: 542-542. DOI: 10.1200/jco.2016.34.15_suppl.542.
Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrantSpoerke JM, Gendreau S, Walter K, Qiu J, Wilson TR, Savage H, Aimi J, Derynck MK, Chen M, Chan IT, Amler LC, Hampton GM, Johnston S, Krop I, Schmid P, Lackner MR. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nature Communications 2016, 7: 11579. PMID: 27174596, PMCID: PMC4869259, DOI: 10.1038/ncomms11579.
Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trialKrop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2016, 17: 811-821. PMID: 27155741, PMCID: PMC5524539, DOI: 10.1016/s1470-2045(16)00106-6.
Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations SummaryHenry N, Somerfield M, Krop I. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations Summary. JCO Oncology Practice 2016, 12: 482-484. DOI: 10.1200/jop.2016.011205.
Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline RecommendationsHenry NL, Somerfield MR, Abramson VG, Allison KH, Anders CK, Chingos DT, Hurria A, Openshaw TH, Krop IE. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations. Journal Of Clinical Oncology 2016, 34: 2303-2311. PMID: 27001586, DOI: 10.1200/jco.2015.65.8609.
Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancerKrop IE, Modi S, LoRusso PM, Pegram M, Guardino E, Althaus B, Lu D, Strasak A, Elias A. Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer. Breast Cancer Research 2016, 18: 34. PMID: 26979312, PMCID: PMC4791863, DOI: 10.1186/s13058-016-0691-7.
Clinical trial enrollment expansion to the community.Kostka J, Zerillo J, Kruse A, Sinclair N, Patrick M, McGovern L, Fuller F, O'Neil K, Hixon N, Weeks K, Johnson B, Krop I, Savoie J, Daftary F, Constantine M, Kaddis M, Rossi H, Tahir N, Norden A. Clinical trial enrollment expansion to the community. Journal Of Clinical Oncology 2016, 34: 112-112. DOI: 10.1200/jco.2016.34.7_suppl.112.
Overcoming Therapeutic Resistance in HER2-Positive Breast Cancers with CDK4/6 InhibitorsGoel S, Wang Q, Watt AC, Tolaney SM, Dillon DA, Li W, Ramm S, Palmer AC, Yuzugullu H, Varadan V, Tuck D, Harris LN, Wong KK, Liu XS, Sicinski P, Winer EP, Krop IE, Zhao JJ. Overcoming Therapeutic Resistance in HER2-Positive Breast Cancers with CDK4/6 Inhibitors. Cancer Cell 2016, 29: 255-269. PMID: 26977878, PMCID: PMC4794996, DOI: 10.1016/j.ccell.2016.02.006.
Abstract OT1-03-14: SANDPIPER: Phase III study of the PI3-kinase inhibitor taselisib (GDC-0032) plus fulvestrant in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer enriched for patients with PIK3CA -mutant tumorsBaselga J, Cortés J, De Laurentiis M, Diéras V, Harbeck N, Hsu J, Jin H, Schimmoller F, Wilson T, Im Y, Jacot W, Krop I, Verma S. Abstract OT1-03-14: SANDPIPER: Phase III study of the PI3-kinase inhibitor taselisib (GDC-0032) plus fulvestrant in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer enriched for patients with PIK3CA -mutant tumors. Cancer Research 2016, 76: ot1-03-14-ot1-03-14. DOI: 10.1158/1538-7445.sabcs15-ot1-03-14.
Abstract OT3-01-01: HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1)Miller K, Cortes J, Hurvitz S, Krop I, Tripathy D, Verma S, Riahi K, Reynolds J, Wickham T, Molnar I, Yardley D. Abstract OT3-01-01: HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1). Cancer Research 2016, 76: ot3-01-01-ot3-01-01. DOI: 10.1158/1538-7445.sabcs15-ot3-01-01.
Abstract P3-07-25: Improved clinical outcomes on enzalutamide observed in patients with PREDICT AR+ triple-negative breast cancer: prognosis or prediction?Miller K, Krop I, Schwartzberg L, Abramson V, Garcia-Estevez L, Eakle J, Nanda R, Yardley D, Ademuyiwa F, Chan S, Crown J, Danso M, Gelmon K, Ma L, Martinez-Janez N, Gradishar W, Steinberg J, Tudor I, Uppal H, Paton V, Parker J, Hudis C, Traina T. Abstract P3-07-25: Improved clinical outcomes on enzalutamide observed in patients with PREDICT AR+ triple-negative breast cancer: prognosis or prediction? Cancer Research 2016, 76: p3-07-25-p3-07-25. DOI: 10.1158/1538-7445.sabcs15-p3-07-25.
Abstract P4-14-01: Trastuzumab emtansine improves overall survival versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer: Final results from the phase 3 EMILIA studyDiéras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop I, Blackwell K, Kang B, Xu J, Green M, Gianni L. Abstract P4-14-01: Trastuzumab emtansine improves overall survival versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer: Final results from the phase 3 EMILIA study. Cancer Research 2016, 76: p4-14-01-p4-14-01. DOI: 10.1158/1538-7445.sabcs15-p4-14-01.
Abstract PD6-03: High prevalence and clonal heterogeneity of ESR1 mutations (mt) in circulating tumor DNA (ctDNA) from patients (pts) enrolled in FERGI, a randomized phase II study testing pictilisib (GDC-0941) in combination with fulvestrant (F) in pts that failed a prior aromatase inhibitor (AI)Spoerke J, Gendreau S, Johnston S, Schmid P, Krop I, Qui J, Derynck M, Chan I, Walter K, Amler L, Hampton G, Lackner M. Abstract PD6-03: High prevalence and clonal heterogeneity of ESR1 mutations (mt) in circulating tumor DNA (ctDNA) from patients (pts) enrolled in FERGI, a randomized phase II study testing pictilisib (GDC-0941) in combination with fulvestrant (F) in pts that failed a prior aromatase inhibitor (AI). Cancer Research 2016, 76: pd6-03-pd6-03. DOI: 10.1158/1538-7445.sabcs15-pd6-03.
Abstract S5-05: Trastuzumab emtansine improves overall survival versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase 3 TH3RESA studyWildiers H, Kim S, Gonzalez-Martin A, LoRusso P, Ferrero J, Yu R, Smitt M, Krop I. Abstract S5-05: Trastuzumab emtansine improves overall survival versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase 3 TH3RESA study. Cancer Research 2016, 76: s5-05-s5-05. DOI: 10.1158/1538-7445.sabcs15-s5-05.
Abstract P4-14-20: A phase 1b study of ONT 380, an oral HER2-specific inhibitor, combined with ado trastuzumab emtansine (T DM1), in HER2+ metastatic breast cancer (MBC)Ferrario C, Hamilton E, Aucoin N, Falkson C, Khan Q, Krop I, Welch S, Bedard P, Conlin A, Chaves J, Vo A, Walker L, Borges V. Abstract P4-14-20: A phase 1b study of ONT 380, an oral HER2-specific inhibitor, combined with ado trastuzumab emtansine (T DM1), in HER2+ metastatic breast cancer (MBC). Cancer Research 2016, 76: p4-14-20-p4-14-20. DOI: 10.1158/1538-7445.sabcs15-p4-14-20.
Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain MetastasesFreedman RA, Gelman RS, Wefel JS, Melisko ME, Hess KR, Connolly RM, Van Poznak CH, Niravath PA, Puhalla SL, Ibrahim N, Blackwell KL, Moy B, Herold C, Liu MC, Lowe A, Agar NY, Ryabin N, Farooq S, Lawler E, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU. Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases. Journal Of Clinical Oncology 2016, 34: 945-952. PMID: 26834058, PMCID: PMC5070554, DOI: 10.1200/jco.2015.63.0343.
Lessons from breast cancer trials of HER2-kinase inhibitorsKrop IE. Lessons from breast cancer trials of HER2-kinase inhibitors. The Lancet Oncology 2016, 17: 267-268. PMID: 26822399, DOI: 10.1016/s1470-2045(16)00004-8.
Response and resistance to BET bromodomain inhibitors in triple-negative breast cancerShu S, Lin CY, He HH, Witwicki RM, Tabassum DP, Roberts JM, Janiszewska M, Jin Huh S, Liang Y, Ryan J, Doherty E, Mohammed H, Guo H, Stover DG, Ekram MB, Peluffo G, Brown J, D’Santos C, Krop I, Dillon D, McKeown M, Ott C, Qi J, Ni M, Rao P, Duarte M, Wu S, Chiang C, Anders L, Young R, Winer E, Letai A, Barry W, Carroll J, Long H, Brown M, Shirley Liu X, Meyer C, Bradner J, Polyak K. Response and resistance to BET bromodomain inhibitors in triple-negative breast cancer. Nature 2016, 529: 413-417. PMID: 26735014, PMCID: PMC4854653, DOI: 10.1038/nature16508.
Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast CancerDang C, Guo H, Najita J, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff AC, Carey LA, Moy B, Groarke J, Moslehi J, Krop I, Burstein HJ, Hudis C, Winer EP, Tolaney SM. Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer. JAMA Oncology 2016, 2: 1-8. PMID: 26539793, PMCID: PMC5654518, DOI: 10.1001/jamaoncol.2015.3709.
PIK3CAH1047R- and Her2-initiated mammary tumors escape PI3K dependency by compensatory activation of MEK-ERK signalingCheng H, Liu P, Ohlson C, Xu E, Symonds L, Isabella A, Muller WJ, Lin NU, Krop IE, Roberts TM, Winer EP, Arteaga CL, Zhao JJ. PIK3CAH1047R- and Her2-initiated mammary tumors escape PI3K dependency by compensatory activation of MEK-ERK signaling. Oncogene 2015, 35: 2961-2970. PMID: 26640141, PMCID: PMC4896860, DOI: 10.1038/onc.2015.377.
Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without LapatinibCarey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, Ollila DW, Krop IE, Henry NL, Weckstein DJ, Anders CK, Singh B, Hoadley KA, Iglesia M, Cheang MC, Perou CM, Winer EP, Hudis CA. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. Journal Of Clinical Oncology 2015, 34: 542-549. PMID: 26527775, PMCID: PMC4980567, DOI: 10.1200/jco.2015.62.1268.
Role of vascular density and normalization in response to neoadjuvant bevacizumab and chemotherapy in breast cancer patientsTolaney SM, Boucher Y, Duda DG, Martin JD, Seano G, Ancukiewicz M, Barry WT, Goel S, Lahdenrata J, Isakoff SJ, Yeh ED, Jain SR, Golshan M, Brock J, Snuderl M, Winer EP, Krop IE, Jain RK. Role of vascular density and normalization in response to neoadjuvant bevacizumab and chemotherapy in breast cancer patients. Proceedings Of The National Academy Of Sciences Of The United States Of America 2015, 112: 14325-14330. PMID: 26578779, PMCID: PMC4655544, DOI: 10.1073/pnas.1518808112.
IN04 OPTIMAL MANAGEMENT OF HER-2+ ABCKrop I. IN04 OPTIMAL MANAGEMENT OF HER-2+ ABC. The Breast 2015, 24: s22-s23. DOI: 10.1016/s0960-9776(15)30017-5.
The Evolving Landscape of HER2 Targeting in Breast CancerMoasser MM, Krop IE. The Evolving Landscape of HER2 Targeting in Breast Cancer. JAMA Oncology 2015, 1: 1154. PMID: 26204261, DOI: 10.1001/jamaoncol.2015.2286.
PI3K-p110α mediates resistance to HER2-targeted therapy in HER2+, PTEN-deficient breast cancersWang Q, Liu P, Spangle JM, Von T, Roberts TM, Lin NU, Krop IE, Winer EP, Zhao JJ. PI3K-p110α mediates resistance to HER2-targeted therapy in HER2+, PTEN-deficient breast cancers. Oncogene 2015, 35: 3607-3612. PMID: 26500061, PMCID: PMC4846581, DOI: 10.1038/onc.2015.406.
Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted AgentsYardley DA, Krop IE, LoRusso PM, Mayer M, Barnett B, Yoo B, Perez EA. Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents. The Cancer Journal 2015, 21: 357-364. PMID: 26389758, DOI: 10.1097/ppo.0000000000000144.
Abstract 2859: Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancer (TNBC)Emens L, Braiteh F, Cassier P, Delord J, Eder J, Fasso M, Xiao Y, Wang Y, Molinero L, Chen D, Krop I. Abstract 2859: Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancer (TNBC). 2015, 2859-2859. DOI: 10.1158/1538-7445.am2015-2859.
Abstract CT234: A phase I study of MM-302, a HER2-targeted PEGylated liposomal doxorubicin, in patients with HER2+ metastatic breast cancerLoRusso P, Krop I, Miller K, Ma C, Siegel B, Shields A, Molnar I, Wickham T, Reynolds J, Campbell K, Hendriks B, McClure T, Moyo V, Munster P. Abstract CT234: A phase I study of MM-302, a HER2-targeted PEGylated liposomal doxorubicin, in patients with HER2+ metastatic breast cancer. 2015, ct234-ct234. DOI: 10.1158/1538-7445.am2015-ct234.
Abstract 2399: Circulating tumor DNA (ctDNA) analysis of PIK3CA and AKT1 mutations in patients enrolled onto the Phase 1b study of the PI3K inhibitor taselisib (GDC-0032) in solid malignanciesWilson T, Savage H, Aimi J, Jin J, Parmar H, Hsu J, Krop I, Saura C, Cervantes A, Sachdev J, Patel M, Cejalvo J, Oliveira M, Winer E, Von Hoff D, Baselga J, Juric D. Abstract 2399: Circulating tumor DNA (ctDNA) analysis of PIK3CA and AKT1 mutations in patients enrolled onto the Phase 1b study of the PI3K inhibitor taselisib (GDC-0032) in solid malignancies. 2015, 2399-2399. DOI: 10.1158/1538-7445.am2015-2399.
Abstract 2836: A discovery and validation set of breast cancer preoperative clinical trials show an increase in immune score upon brief-exposure to trastuzumab (T) and the HER2-enriched subtype predict response to combination chemotherapy and TVaradan V, Miskimen K, Parsai S, Krop I, Winer E, Bossuyt V, Abu-Khalaf M, Sikov W, Harris L. Abstract 2836: A discovery and validation set of breast cancer preoperative clinical trials show an increase in immune score upon brief-exposure to trastuzumab (T) and the HER2-enriched subtype predict response to combination chemotherapy and T. 2015, 2836-2836. DOI: 10.1158/1538-7445.am2015-2836.
Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)Lin NU, Guo H, Yap JT, Mayer IA, Falkson CI, Hobday TJ, Dees EC, Richardson AL, Nanda R, Rimawi MF, Ryabin N, Najita JS, Barry WT, Arteaga CL, Wolff AC, Krop IE, Winer EP, Van den Abbeele AD. Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003). Journal Of Clinical Oncology 2015, 33: 2623-2631. PMID: 26169615, PMCID: PMC4534525, DOI: 10.1200/jco.2014.60.0353.
Phase II study of tivantinib (ARQ 197) in patients with metastatic triple-negative breast cancerTolaney SM, Tan S, Guo H, Barry W, Van Allen E, Wagle N, Brock J, Larrabee K, Paweletz C, Ivanova E, Janne P, Overmoyer B, Wright JJ, Shapiro GI, Winer EP, Krop IE. Phase II study of tivantinib (ARQ 197) in patients with metastatic triple-negative breast cancer. Investigational New Drugs 2015, 33: 1108-1114. PMID: 26123926, PMCID: PMC4608248, DOI: 10.1007/s10637-015-0269-8.
Whole exome sequencing (WES) in HER2+ metastatic breast cancer (MBC) patients (pts) with extraordinary responses to trastuzumab (T).Luis I, Oh C, Wang Z, Dipiro P, Macrae E, Painter C, Kryukov G, Krop I, Winer E, Lin N, Wagle N. Whole exome sequencing (WES) in HER2+ metastatic breast cancer (MBC) patients (pts) with extraordinary responses to trastuzumab (T). Journal Of Clinical Oncology 2015, 33: 611-611. DOI: 10.1200/jco.2015.33.15_suppl.611.
ONT-380 in the treatment of HER2+ breast cancer central nervous system (CNS) metastases (mets).Ferrario C, Welch S, Chaves J, Walker L, Krop I, Hamilton E, Borges V, Moulder S. ONT-380 in the treatment of HER2+ breast cancer central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2015, 33: 612-612. DOI: 10.1200/jco.2015.33.15_suppl.612.
First-in-human dose escalation, safety, and PK study of a novel EFNA4-ADC in patients with advanced solid tumors.Hong D, Garrido-Laguna I, Krop I, Subbiah V, Werner T, Cotter C, Hamilton E, Velastegui K, Xuan D, Bugarini R, Gollerkeri A, Burris H. First-in-human dose escalation, safety, and PK study of a novel EFNA4-ADC in patients with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: 2520-2520. DOI: 10.1200/jco.2015.33.15_suppl.2520.
HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1).Miller K, Cortes J, Hurvitz S, Krop I, Tripathy D, Verma S, Riahi K, Reynolds J, Wickham T, Molnar I, Yardley D. HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1). Journal Of Clinical Oncology 2015, 33: tps641-tps641. DOI: 10.1200/jco.2015.33.15_suppl.tps641.
Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)Ruddy KJ, Guo H, Barry W, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Hudis C, Krop IE, Burstein HJ, Winer EP, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial). Breast Cancer Research And Treatment 2015, 151: 589-596. PMID: 25981899, PMCID: PMC5057177, DOI: 10.1007/s10549-015-3426-z.
Personalization of loco-regional care for primary breast cancer patients (part 1)Toi M, Winer EP, Benson JR, Inamoto T, Forbes JF, von Minckwitz G, Robertson J, Grobmyer SR, Jatoi I, Sasano H, Kunkler I, Ho AY, Yamauchi C, Chow L, Huang CS, Han W, Noguchi S, Pegram MD, Yamauchi H, Lee ES, Larionov AA, Bevilacqua J, Yoshimura M, Sugie T, Yamauchi A, Krop IE, Noh DY, Klimberg VS. Personalization of loco-regional care for primary breast cancer patients (part 1). Future Oncology 2015, 11: 1297-1300. PMID: 25952777, DOI: 10.2217/fon.15.65.
Personalization of loco-regional care for primary breast cancer patients (part 2)Toi M, Winer EP, Benson JR, Inamoto T, Forbes JF, von Minckwitz G, Robertson J, Grobmyer SR, Jatoi I, Sasano H, Kunkler I, Ho AY, Yamauchi C, Chow L, Huang CS, Han W, Noguchi S, Pegram MD, Yamauchi H, Lee ES, Larionov AA, Bevilacqua J, Yoshimura M, Sugie T, Yamauchi A, Krop IE, Noh DY, Klimberg VS. Personalization of loco-regional care for primary breast cancer patients (part 2). Future Oncology 2015, 11: 1301-1305. PMID: 25952778, DOI: 10.2217/fon.15.66.
Abstract OT3-1-10: HERmione: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with physician's choice of chemotherapy plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer, previously treated with peMiller K, Cortes J, Hurvitz S, Krop I, Tripathy D, Verma S, Riahi K, Yardley D. Abstract OT3-1-10: HERmione: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with physician's choice of chemotherapy plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer, previously treated with pe. 2015, ot3-1-10-ot3-1-10. DOI: 10.1158/1538-7445.sabcs14-ot3-1-10.
Abstract P3-11-03: A randomized, phase 2 trial of preoperative MM-121 with paclitaxel in triple negative (TN) and hormone receptor (HR) positive, HER2-negative breast cancerHolmes F, McIntyre K, Krop I, Osborne C, Smith II J, Modiano M, Gupta M, Downey L, Nanda R, Saleh M, Young J, Horgan K, Kubasek W, MacBeath G, Danso M, O'Shaughnessy J. Abstract P3-11-03: A randomized, phase 2 trial of preoperative MM-121 with paclitaxel in triple negative (TN) and hormone receptor (HR) positive, HER2-negative breast cancer. 2015, p3-11-03-p3-11-03. DOI: 10.1158/1538-7445.sabcs14-p3-11-03.
Abstract P4-15-04: Effect of pre-treatment with cyclophosphamide on MM-302 (HER2-targeted liposomal doxorubicin) deposition in HER2-positive metastatic breast cancer patients assessed by 64 Cu-MM-302 PET/CTMiller K, LoRusso P, Munster P, Krop I, Ma C, Lee H, Reynolds J, Campbell K, Moyo V, Hendriks B, Wickham T, Siegel B, Shields A. Abstract P4-15-04: Effect of pre-treatment with cyclophosphamide on MM-302 (HER2-targeted liposomal doxorubicin) deposition in HER2-positive metastatic breast cancer patients assessed by 64 Cu-MM-302 PET/CT. 2015, p4-15-04-p4-15-04. DOI: 10.1158/1538-7445.sabcs14-p4-15-04.
Abstract P4-15-08: A phase 1b study of ONT-380, an oral HER2-specific inhibitor, combined with ado-trastuzumab emtansine (T-DM1), in HER2+ metastatic breast cancer (MBC)Borges V, Hamilton E, Yardley D, Chaves J, Aucoin N, Ferrario C, Walker L, Krop I. Abstract P4-15-08: A phase 1b study of ONT-380, an oral HER2-specific inhibitor, combined with ado-trastuzumab emtansine (T-DM1), in HER2+ metastatic breast cancer (MBC). 2015, p4-15-08-p4-15-08. DOI: 10.1158/1538-7445.sabcs14-p4-15-08.
Abstract PD1-6: Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancerEmens L, Braiteh F, Cassier P, DeLord J, Eder J, Shen X, Xiao Y, Wang Y, Hegde P, Chen D, Krop I. Abstract PD1-6: Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancer. 2015, pd1-6-pd1-6. DOI: 10.1158/1538-7445.sabcs14-pd1-6.
Abstract S6-02: TBCRC023: A randomized multicenter phase II neoadjuvant trial of lapatinib plus trastuzumab, with endcorine therapy and without chemotherapy, for 12 vs. 24 weeks in patients with HER2 overexpressing breast cancerRimawi M, Niravath P, Wang T, Rexer B, Forero A, Wolff A, Nanda R, Storniolo A, Krop I, Goetz M, Nangia J, Jiralerspong S, Pavlick A, Gutierrez C, Schiff R, Hilsenbeck S, Osborne C. Abstract S6-02: TBCRC023: A randomized multicenter phase II neoadjuvant trial of lapatinib plus trastuzumab, with endcorine therapy and without chemotherapy, for 12 vs. 24 weeks in patients with HER2 overexpressing breast cancer. 2015, s6-02-s6-02. DOI: 10.1158/1538-7445.sabcs14-s6-02.
Abstract P3-06-24: Brief exposure to trastuzumab prior to preoperative chemotherapy confirms predictors of response to treatmentVadodkar A, Varadan V, Miskimen K, Bossuyt V, Abu-khalaf M, Krop I, Winer E, Harris L. Abstract P3-06-24: Brief exposure to trastuzumab prior to preoperative chemotherapy confirms predictors of response to treatment. 2015, p3-06-24-p3-06-24. DOI: 10.1158/1538-7445.sabcs14-p3-06-24.
Abstract P4-01-02: Prospective characterization of HER2-positive circulating tumor cells in patients with HER2-negative metastatic breast cancerKrop I, Macrae E, Galler S, Bischoff F, Fauni R, Sales E, Huynh L, Mitchell C, Clarin-Tamayo T, Anderson M, Abad L, Winer E. Abstract P4-01-02: Prospective characterization of HER2-positive circulating tumor cells in patients with HER2-negative metastatic breast cancer. 2015, p4-01-02-p4-01-02. DOI: 10.1158/1538-7445.sabcs14-p4-01-02.
Abstract PD3-5: Whole exome sequencing (WES) of HER2+ metastatic breast cancer (MBC) from patients with or without prior trastuzumab (T): A correlative analysis of TBCRC003Wagle N, Lin N, Richardson A, Leshchiner I, Mayer I, Forero-Torres A, Hobday T, Dees E, Nanda R, Rimawi M, Guo H, Barry W, Bose R, Shen W, Wolff A, Gabriel S, Garraway L, Winer E, Krop I. Abstract PD3-5: Whole exome sequencing (WES) of HER2+ metastatic breast cancer (MBC) from patients with or without prior trastuzumab (T): A correlative analysis of TBCRC003. 2015, pd3-5-pd3-5. DOI: 10.1158/1538-7445.sabcs14-pd3-5.
Abstract PD5-2: Ph1b study of the PI3K inhibitor taselisib (GDC-0032) in combination with letrozole in patients with hormone receptor-positive advanced breast cancerSaura C, Sachdev J, Patel M, Cervantes A, Juric D, Infante J, Richards D, Sanabria S, Lu X, Ware J, Wilson T, Parmar H, Hsu J, Oliveira M, Winer E, Von Hoff D, Baselga J, Krop I. Abstract PD5-2: Ph1b study of the PI3K inhibitor taselisib (GDC-0032) in combination with letrozole in patients with hormone receptor-positive advanced breast cancer. 2015, pd5-2-pd5-2. DOI: 10.1158/1538-7445.sabcs14-pd5-2.
Abstract S3-06: Mutational analysis of CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel (T) and trastuzumab (H) with or without lapatinib (L) for HER2-positive breast cancerHoadley K, Barry W, Pitcher B, Parker J, Wilkerson M, Irvin W, Henry N, Tolaney S, Dang C, Krop I, Berry D, Mardis E, Perou C, Winer E, Hudis C, Carey L. Abstract S3-06: Mutational analysis of CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel (T) and trastuzumab (H) with or without lapatinib (L) for HER2-positive breast cancer. 2015, s3-06-s3-06. DOI: 10.1158/1538-7445.sabcs14-s3-06.
Deciphering the Role of Phosphatidylinositol 3-Kinase Mutations in Human Epidermal Growth Factor Receptor 2–Positive Breast CancerGoel S, Krop IE. Deciphering the Role of Phosphatidylinositol 3-Kinase Mutations in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2015, 33: 1407-1409. PMID: 25800754, DOI: 10.1200/jco.2014.60.0742.
Feasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast CancerKrop IE, Suter TM, Dang CT, Dirix L, Romieu G, Zamagni C, Citron ML, Campone M, Xu N, Smitt M, Gianni L. Feasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer. Journal Of Clinical Oncology 2015, 33: 1136-1142. PMID: 25713436, PMCID: PMC5657012, DOI: 10.1200/jco.2014.58.7782.
SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast CancerGonzalez-Angulo AM, Krop I, Akcakanat A, Chen H, Liu S, Li Y, Culotta KS, Tarco E, Piha-Paul S, Moulder-Thompson S, Velez-Bravo V, Sahin AA, Doyle LA, Do KA, Winer EP, Mills GB, Kurzrock R, Meric-Bernstam F. SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer. Journal Of The National Cancer Institute 2015, 107 PMID: 25688104, PMCID: PMC4342675, DOI: 10.1093/jnci/dju493.
Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast CancerTolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer. New England Journal Of Medicine 2015, 372: 134-141. PMID: 25564897, PMCID: PMC4313867, DOI: 10.1056/nejmoa1406281.
Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancerTolaney S, Burris H, Gartner E, Mayer IA, Saura C, Maurer M, Ciruelos E, Garcia AA, Campana F, Wu B, Xu Y, Jiang J, Winer E, Krop I. Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2014, 149: 151-161. PMID: 25537644, DOI: 10.1007/s10549-014-3248-4.
Current Perspectives on HER2-Positive BCParry N, Moasser M, Loibl S, Krop I. Current Perspectives on HER2-Positive BC. MD Conference Express 2014, 14: 17-18. DOI: 10.1177/1559897715572117.
NI-23BRAIN BREAST METASTASES RESPOND TO ANTI-ANGIOGENIC THERAPY BY MODES OF VASCULAR NORMALIZATIONEmblem K, Pinho M, Chandra V, Gerstner E, Stufflebeam S, Sorenson G, Harris G, Freedman R, Sohl J, Younger J, Krop I, Winer E, Lin N. NI-23BRAIN BREAST METASTASES RESPOND TO ANTI-ANGIOGENIC THERAPY BY MODES OF VASCULAR NORMALIZATION. Neuro-Oncology 2014, 16: v143-v143. PMCID: PMC4218348, DOI: 10.1093/neuonc/nou264.22.
Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA †Krop IE, Lin NU, Blackwell K, Guardino E, Huober J, Lu M, Miles D, Samant M, Welslau M, Diéras V. Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA †. Annals Of Oncology 2014, 26: 113-119. PMID: 25355722, PMCID: PMC4679405, DOI: 10.1093/annonc/mdu486.
Abstract 915: Expanded biomarker results from a phase I dose escalation study of GDC-0032, a beta isoform-sparing PI3K inhibitorWilson T, Savage H, O'Brien C, Sanabria S, Lin R, Wagle M, Yan Y, Lackner M, Parmar H, Hsu J, Juric D, Krop I, Ramanathan R, Hoff D, Baselga J. Abstract 915: Expanded biomarker results from a phase I dose escalation study of GDC-0032, a beta isoform-sparing PI3K inhibitor. 2014, 915-915. DOI: 10.1158/1538-7445.am2014-915.
ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)Cardoso F, Costa A, Norton L, Senkus E, Aapro M, André F, Barrios C, Bergh J, Biganzoli L, Blackwell K, Cardoso M, Cufer T, Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano S, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin U, Mayer M, Merjaver S, Nordström E, Pagani O, Partridge A, Penault-Llorca F, Piccart M, Rugo H, Sledge G, Thomssen C, Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). The Breast 2014, 23: 489-502. PMID: 25244983, DOI: 10.1016/j.breast.2014.08.009.
ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2) †Cardoso F, Costa A, Norton L, Senkus E, Aapro M, André F, Barrios C, Bergh J, Biganzoli L, Blackwell K, Cardoso M, Cufer T, Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano S, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin U, Mayer M, Merjaver S, Nordström E, Pagani O, Partridge A, Penault-Llorca F, Piccart M, Rugo H, Sledge G, Thomssen C, Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2) †. Annals Of Oncology 2014, 25: 1871-1888. PMID: 25234545, PMCID: PMC4176456, DOI: 10.1093/annonc/mdu385.
Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer.Bartley K, Wildiers H, Kim S, Krop I, Kang J, Yu R, Leung A, Trudeau C, Gonzalez-Martin A. Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer. Journal Of Clinical Oncology 2014, 32: 153-153. DOI: 10.1200/jco.2014.32.26_suppl.153.
Phosphorylation of ETS1 by Src Family Kinases Prevents Its Recognition by the COP1 Tumor SuppressorLu G, Zhang Q, Huang Y, Song J, Tomaino R, Ehrenberger T, Lim E, Liu W, Bronson RT, Bowden M, Brock J, Krop IE, Dillon DA, Gygi SP, Mills GB, Richardson AL, Signoretti S, Yaffe MB, Kaelin WG. Phosphorylation of ETS1 by Src Family Kinases Prevents Its Recognition by the COP1 Tumor Suppressor. Cancer Cell 2014, 26: 222-234. PMID: 25117710, PMCID: PMC4169234, DOI: 10.1016/j.ccr.2014.06.026.
Seeds and Soil: Unraveling the Role of Local Tumor Stroma in Distant MetastasisDuda DG, Ancukiewicz M, Isakoff SJ, Krop IE, Jain RK. Seeds and Soil: Unraveling the Role of Local Tumor Stroma in Distant Metastasis. Journal Of The National Cancer Institute 2014, 106: dju187-dju187. PMID: 25082335, DOI: 10.1093/jnci/dju187.
Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety AnalysisDiéras V, Harbeck N, Budd GT, Greenson JK, Guardino AE, Samant M, Chernyukhin N, Smitt MC, Krop IE. Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis. Journal Of Clinical Oncology 2014, 32: 2750-2757. PMID: 25024070, DOI: 10.1200/jco.2013.54.4999.
A phase II study of tivantinib (ARQ-197) for metastatic triple-negative breast cancer.Tolaney S, Guo H, Barry W, Larrabee K, Brock J, Wagle N, Van Allen E, Paweletz C, Ivanova E, Janne P, Overmoyer B, Wright J, Shapiro G, Winer E, Krop I. A phase II study of tivantinib (ARQ-197) for metastatic triple-negative breast cancer. Journal Of Clinical Oncology 2014, 32: 1106-1106. DOI: 10.1200/jco.2014.32.15_suppl.1106.
Gene expression signatures in pre- and post-therapy (Rx) specimens from CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer (BrCa).Carey L, Barry W, Pitcher B, Hoadley K, Cheang M, Anders C, Henry N, Tolaney S, Dang C, Krop I, Harris L, Berry D, Perou C, Winer E, Hudis C. Gene expression signatures in pre- and post-therapy (Rx) specimens from CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer (BrCa). Journal Of Clinical Oncology 2014, 32: 506-506. DOI: 10.1200/jco.2014.32.15_suppl.506.
TBCRC 022: Phase II trial of neratinib for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer and brain metastases (BCBM).Freedman R, Gelman R, Wefel J, Krop I, Melisko M, Lowe A, Agar N, Blackwell K, Connolly R, Niravath P, Van Poznak C, Puhalla S, Ryabin N, Lawler E, Ibrahim N, Liu M, Wolff A, Winer E, Lin N. TBCRC 022: Phase II trial of neratinib for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer and brain metastases (BCBM). Journal Of Clinical Oncology 2014, 32: 528-528. DOI: 10.1200/jco.2014.32.15_suppl.528.
Whole-exome sequencing (WES) of HER2+ metastatic breast cancer (MBC) from patients (pts) treated with prior trastuzumab (T): A correlative analysis of TBCRC003.Wagle N, Lin N, Richardson A, Leshchiner I, Mayer I, Forero-Torres A, Hobday T, Dees E, Nanda R, Rimawi M, Guo H, Barry W, Wolff A, Gabriel S, Garraway L, Winer E, Krop I. Whole-exome sequencing (WES) of HER2+ metastatic breast cancer (MBC) from patients (pts) treated with prior trastuzumab (T): A correlative analysis of TBCRC003. Journal Of Clinical Oncology 2014, 32: 536-536. DOI: 10.1200/jco.2014.32.15_suppl.536.
Phase I dose-escalation trial of ONT-380 in combination with trastuzumab in participants with brain metastases from HER2+ breast cancer.Metzger-Filho O, Barry W, Krop I, Younger W, Lawler E, Winer E, Lin N. Phase I dose-escalation trial of ONT-380 in combination with trastuzumab in participants with brain metastases from HER2+ breast cancer. Journal Of Clinical Oncology 2014, 32: tps660-tps660. DOI: 10.1200/jco.2014.32.15_suppl.tps660.
A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with metastatic, human epidermal growth factor receptor 2-positive breast cancer.Freedman R, Luis I, Barry W, Krop I, Wagle N, Lowe A, Galler S, Sohl J, Isakoff S, Tung N, Winer E, Lin N. A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with metastatic, human epidermal growth factor receptor 2-positive breast cancer. Journal Of Clinical Oncology 2014, 32: tps668-tps668. DOI: 10.1200/jco.2014.32.15_suppl.tps668.
Relationship between tumor biomarkers (BM) and efficacy in TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in HER2-positive advanced breast cancer (BC) previously treated with trastuzumab and lapatinib.Kim S, Wildiers H, Krop I, Leung A, Trudeau C, Yu R, de Haas S, Gonzalez-Martin A. Relationship between tumor biomarkers (BM) and efficacy in TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in HER2-positive advanced breast cancer (BC) previously treated with trastuzumab and lapatinib. Journal Of Clinical Oncology 2014, 32: 605-605. DOI: 10.1200/jco.2014.32.15_suppl.605.
A phase 1b study of ONT-380, an oral HER2-specific inhibitor, combined with ado-trastuzumab emtansine (T-DM1), in HER2+ metastatic breast cancer (MBC).Borges V, Hamilton E, Yardley D, Moulder S, Hortobagyi G, Walker L, Krop I. A phase 1b study of ONT-380, an oral HER2-specific inhibitor, combined with ado-trastuzumab emtansine (T-DM1), in HER2+ metastatic breast cancer (MBC). Journal Of Clinical Oncology 2014, 32: tps662-tps662. DOI: 10.1200/jco.2014.32.15_suppl.tps662.
Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice GuidelineRamakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Gonzalez-Angulo AM, Kirshner JJ, Krop I, Levinson J, Modi S, Patt DA, Perez EA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2100-2108. PMID: 24799487, PMCID: PMC6366342, DOI: 10.1200/jco.2013.54.0955.
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice GuidelineGiordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.
Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trialKrop IE, Kim SB, González-Martín A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H, collaborators O. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. The Lancet Oncology 2014, 15: 689-699. PMID: 24793816, DOI: 10.1016/s1470-2045(14)70178-0.
New research on the treatment of small HER2-positive breast cancers.Krop IE. New research on the treatment of small HER2-positive breast cancers. Clinical Advances In Hematology And Oncology 2014, 12: 124-7. PMID: 24892258.
A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancerTolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Medicine 2014, 3: 293-299. PMID: 24464780, PMCID: PMC3987079, DOI: 10.1002/cam4.164.
Trastuzumab Emtansine: A Novel Antibody–Drug Conjugate for HER2-Positive Breast CancerKrop I, Winer EP. Trastuzumab Emtansine: A Novel Antibody–Drug Conjugate for HER2-Positive Breast Cancer. Clinical Cancer Research 2014, 20: 15-20. PMID: 24135146, DOI: 10.1158/1078-0432.ccr-13-0541.
Abstract P2-15-03: Cardiac safety of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (EBC): Final data from TDM4874gKrop I, Suter T, Dirix L, Romieu G, Zamagni C, Citron M, Campone M, Dang C, Xu N, Smitt M, Gianni L. Abstract P2-15-03: Cardiac safety of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (EBC): Final data from TDM4874g. Cancer Research 2013, 73: p2-15-03-p2-15-03. DOI: 10.1158/0008-5472.sabcs13-p2-15-03.
Abstract P4-12-09: Results from a phase 2a study of trastuzumab emtansine, paclitaxel, and pertuzumab in patients with HER2-positive metastatic breast cancerElias A, Modi S, Krop I, Pegram M, Ipe D, Guardino E, Althaus B, LoRusso P. Abstract P4-12-09: Results from a phase 2a study of trastuzumab emtansine, paclitaxel, and pertuzumab in patients with HER2-positive metastatic breast cancer. Cancer Research 2013, 73: p4-12-09-p4-12-09. DOI: 10.1158/0008-5472.sabcs13-p4-12-09.
Abstract P4-12-27: Efficacy and safety of trastuzumab emtansine (T-DM1) vs lapatinib plus capecitabine (XL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) and central nervous system (CNS) metastases: Results from a retrospective exploratory analysis of EMILIAKrop I, Lin N, Blackwell K, Guardino E, Huober J, Lu M, Miles D, Samant M, Welslau M, Diéras V. Abstract P4-12-27: Efficacy and safety of trastuzumab emtansine (T-DM1) vs lapatinib plus capecitabine (XL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) and central nervous system (CNS) metastases: Results from a retrospective exploratory analysis of EMILIA. Cancer Research 2013, 73: p4-12-27-p4-12-27. DOI: 10.1158/0008-5472.sabcs13-p4-12-27.
Abstract P4-12-29: Assessment of safety and activity in an expanded phase 1 study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced HER2-positive (HER2+) breast cancerMunster P, Krop I, Miller K, Dhindsa N, Niyijiza C, Nielsen U, Odueyungbo A, Rajarethinam A, Marande M, Campbell K, Geretti E, Reynolds J, Hendriks B, Wickham T, Moyo V, LoRusso P. Abstract P4-12-29: Assessment of safety and activity in an expanded phase 1 study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced HER2-positive (HER2+) breast cancer. Cancer Research 2013, 73: p4-12-29-p4-12-29. DOI: 10.1158/0008-5472.sabcs13-p4-12-29.
Abstract PD1-3: Ph1b study of the PI3K inhibitor GDC-0032 in combination with fulvestrant in patients with hormone receptor-positive advanced breast cancerJuric D, Saura C, Cervantes A, Kurkjian C, Patel M, Sachdev J, Mayer I, Krop I, Oliveira M, Sanabria S, Cheeti S, Lin R, Graham R, Wilson T, Parmar H, Hsu J, Von Hoff D, Baselga J. Abstract PD1-3: Ph1b study of the PI3K inhibitor GDC-0032 in combination with fulvestrant in patients with hormone receptor-positive advanced breast cancer. Cancer Research 2013, 73: pd1-3-pd1-3. DOI: 10.1158/0008-5472.sabcs13-pd1-3.
Abstract OT3-2-05: Randomized phase II study of fulvestrant with or without ganetespib in patients (pts) with hormone receptor (HR)-positive metastatic breast cancerLin N, Whitesell L, Gelman R, Mayer E, Krop I, Santagata S, Lowe A, Proia D, Farooq S, Brown M, Iannone M, Lindquist S, Winer E. Abstract OT3-2-05: Randomized phase II study of fulvestrant with or without ganetespib in patients (pts) with hormone receptor (HR)-positive metastatic breast cancer. Cancer Research 2013, 73: ot3-2-05-ot3-2-05. DOI: 10.1158/0008-5472.sabcs13-ot3-2-05.
Abstract P3-08-05: Chemotherapy-related amenorrhea on adjuvant paclitaxel-trastuzumab (APT trial)Ruddy K, Tolaney S, Guo H, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Overmoyer B, Hudis C, Krop I, Burstein H, Winer E, Partridge A. Abstract P3-08-05: Chemotherapy-related amenorrhea on adjuvant paclitaxel-trastuzumab (APT trial). Cancer Research 2013, 73: p3-08-05-p3-08-05. DOI: 10.1158/0008-5472.sabcs13-p3-08-05.
Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC)Tolaney S, Barry W, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Overmoyer B, Partridge A, Guo H, Hudis C, Krop I, Burstein H, Winer E. Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Cancer Research 2013, 73: s1-04-s1-04. DOI: 10.1158/0008-5472.sabcs13-s1-04.
Trastuzumab: Qui Bono?Krop IE, Burstein HJ. Trastuzumab: Qui Bono? Journal Of The National Cancer Institute 2013, 105: 1772-1775. PMID: 24262439, DOI: 10.1093/jnci/djt336.
Pertuzumab: Optimizing HER2 BlockadeMetzger-Filho O, Winer EP, Krop I. Pertuzumab: Optimizing HER2 Blockade. Clinical Cancer Research 2013, 19: 5552-5556. PMID: 23942091, DOI: 10.1158/1078-0432.ccr-13-0518.
Prospective clinical experience with research biopsies in breast cancer patientsVaz-Luis I, Zeghibe CA, Frank ES, Sohl J, Washington KE, Silverman SG, Fonte JM, Mayer EL, Overmoyer BA, Richardson AL, Krop IE, Winer EP, Lin NU. Prospective clinical experience with research biopsies in breast cancer patients. Breast Cancer Research And Treatment 2013, 142: 203-209. PMID: 24113744, PMCID: PMC3825285, DOI: 10.1007/s10549-013-2717-5.
Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstructionKansal KJ, Dominici LS, Tolaney SM, Isakoff SJ, Smith BL, Jiang W, Brock JE, Winer EP, Krop IE, Golshan M. Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction. Breast Cancer Research And Treatment 2013, 141: 255-259. PMID: 24026859, DOI: 10.1007/s10549-013-2682-z.
Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study.Yardley D, Krop I, LoRusso P, Robert N, Mayer M, Abidoye O, Lai C, Yoo B, Perez E. Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study. Journal Of Clinical Oncology 2013, 31: 166-166. DOI: 10.1200/jco.2013.31.26_suppl.166.
Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort StudyVaz-Luis I, Seah D, Olson EM, Wagle N, Metzger-Filho O, Sohl J, Litsas G, Burstein HJ, Krop IE, Winer EP, Lin NU. Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study. Clinical Breast Cancer 2013, 13: 254-263. PMID: 23829891, PMCID: PMC4084778, DOI: 10.1016/j.clbc.2013.02.010.
Gauging NOTCH1 Activation in Cancer Using ImmunohistochemistryKluk MJ, Ashworth T, Wang H, Knoechel B, Mason EF, Morgan EA, Dorfman D, Pinkus G, Weigert O, Hornick JL, Chirieac LR, Hirsch M, Oh DJ, South AP, Leigh IM, Pourreyron C, Cassidy AJ, DeAngelo DJ, Weinstock DM, Krop IE, Dillon D, Brock JE, Lazar AJ, Peto M, Cho RJ, Stoeck A, Haines BB, Sathayanrayanan S, Rodig S, Aster JC. Gauging NOTCH1 Activation in Cancer Using Immunohistochemistry. PLOS ONE 2013, 8: e67306. PMID: 23825651, PMCID: PMC3688991, DOI: 10.1371/journal.pone.0067306.
Differential changes in tissue biomarkers after bevacizumab (BEV) alone in a neoadjuvant study of BEV and chemotherapy in ER+ breast cancer (BC) versus triple-negative breast cancer (TNBC) patients (pts).Boucher Y, Martin J, Tolaney S, Ancukiewicz M, Seano G, Goel S, Yeh E, Meyer J, Isakoff S, Duda D, Winer E, Krop I, Jain R. Differential changes in tissue biomarkers after bevacizumab (BEV) alone in a neoadjuvant study of BEV and chemotherapy in ER+ breast cancer (BC) versus triple-negative breast cancer (TNBC) patients (pts). Journal Of Clinical Oncology 2013, 31: 1065-1065. DOI: 10.1200/jco.2013.31.15_suppl.1065.
Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction.Kansal K, Dominici L, Tolaney S, Isakoff S, Krop I, Smith B, Jiang W, Potler H, Brock J, Winer E, Golshan M. Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction. Journal Of Clinical Oncology 2013, 31: 1100-1100. DOI: 10.1200/jco.2013.31.15_suppl.1100.
Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer.Carey L, Berry D, Ollila D, Harris L, Krop I, Weckstein D, Henry N, Anders C, Cirrincione C, Winer E, Perou C, Hudis C. Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer. Journal Of Clinical Oncology 2013, 31: 500-500. DOI: 10.1200/jco.2013.31.15_suppl.500.
Phase II trial of carboplatin (C) and bevacizumab (BEV) in patients (pts) with breast cancer brain metastases (BCBM).Lin N, Gelman R, Younger W, Sohl J, Freedman R, Sorensen A, Bullitt E, Harris G, Morganstern D, Schneider B, Krop I, Winer E. Phase II trial of carboplatin (C) and bevacizumab (BEV) in patients (pts) with breast cancer brain metastases (BCBM). Journal Of Clinical Oncology 2013, 31: 513-513. DOI: 10.1200/jco.2013.31.15_suppl.513.
Prospective clinical experience with research biopsies in breast cancer patients.Zeghibe C, Luis I, Frank E, Sohl J, Washington K, Silverman S, Fonte J, Mayer E, Overmoyer B, Richardson A, Krop I, Winer E, Lin N. Prospective clinical experience with research biopsies in breast cancer patients. Journal Of Clinical Oncology 2013, 31: e17574-e17574. DOI: 10.1200/jco.2013.31.15_suppl.e17574.
Phase II study of ruxolitinib in patients with pStat3+ breast cancer.Lin N, Gelman R, Brock J, Bardia A, Mayer E, Overmoyer B, Wang V, Iannone M, Krop I, Polyak K, Winer E. Phase II study of ruxolitinib in patients with pStat3+ breast cancer. Journal Of Clinical Oncology 2013, 31: tps1134-tps1134. DOI: 10.1200/jco.2013.31.15_suppl.tps1134.
A phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancerLin NU, Seah DS, Gelman R, Desantis S, Mayer EL, Isakoff S, DiPiro P, Krop IE, Come SE, Weckstein D, Winer EP, Burstein HJ. A phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2013, 139: 403-410. PMID: 23645007, DOI: 10.1007/s10549-013-2551-9.
Beyond Trastuzumab and Lapatinib: New Options for HER2-Positive Breast CancerZardavas D, Cameron D, Krop I, Piccart M. Beyond Trastuzumab and Lapatinib: New Options for HER2-Positive Breast Cancer. American Society Of Clinical Oncology Educational Book 2013, e2-e11. DOI: 10.14694/edbook_am.2013.33.e2.
HER2-positive breast cancer—sifting through many good optionsKrop IE. HER2-positive breast cancer—sifting through many good options. Nature Reviews Clinical Oncology 2013, 10: 312-313. PMID: 23629473, DOI: 10.1038/nrclinonc.2013.72.
Abstract LB-64: GDC-0032, a beta isoform-sparing PI3K inhibitor: Results of a first-in-human phase Ia dose escalation study.Juric D, Krop I, Ramanathan R, Xiao J, Sanabria S, Wilson T, Choi Y, Parmar H, Hsu J, Baselga J, Von Hoff D. Abstract LB-64: GDC-0032, a beta isoform-sparing PI3K inhibitor: Results of a first-in-human phase Ia dose escalation study. Cancer Research 2013, 73: lb-64-lb-64. DOI: 10.1158/1538-7445.am2013-lb-64.
Abstract LB-76: Tissue biomarkers and interstitial fluid pressure in a phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC)Boucher Y, Martin J, Tolaney S, Seano G, Goel S, Ancukiewicz M, Isakoff S, Winer E, Krop I, Jain R. Abstract LB-76: Tissue biomarkers and interstitial fluid pressure in a phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC). Cancer Research 2013, 73: lb-76-lb-76. DOI: 10.1158/1538-7445.am2013-lb-76.
Abstract LB-81: A study of circulating biomarkers of angiogenesis and inflammation in ER+ breast cancer (BC) versus triple-negative breast cancer (TNBC) patients enrolled in a phase II study of preoperative treatment with 1 cycle of Bevacizumab followed by standard chemoDuda D, Tolaney S, Ancukiewicz M, Winer E, Krop I, Jain R. Abstract LB-81: A study of circulating biomarkers of angiogenesis and inflammation in ER+ breast cancer (BC) versus triple-negative breast cancer (TNBC) patients enrolled in a phase II study of preoperative treatment with 1 cycle of Bevacizumab followed by standard chemo. Cancer Research 2013, 73: lb-81-lb-81. DOI: 10.1158/1538-7445.am2013-lb-81.
Prevalence of germline TP53 mutations in HER2+ breast cancer patientsRath MG, Masciari S, Gelman R, Miron A, Miron P, Foley K, Richardson AL, Krop IE, Verselis SJ, Dillon DA, Garber JE. Prevalence of germline TP53 mutations in HER2+ breast cancer patients. Breast Cancer Research And Treatment 2013, 139: 193-198. PMID: 23580068, PMCID: PMC4280061, DOI: 10.1007/s10549-012-2375-z.
A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancerTolaney SM, Najita J, Sperinde J, Huang W, Chen WY, Savoie J, Fornier M, Winer EP, Bunnell C, Krop IE. A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer. Annals Of Oncology 2013, 24: 1841-1847. PMID: 23559151, PMCID: PMC3690910, DOI: 10.1093/annonc/mdt121.
An Integrated Multiple-Analyte Pharmacokinetic Model to Characterize Trastuzumab Emtansine (T-DM1) Clearance Pathways and to Evaluate Reduced Pharmacokinetic Sampling in Patients with HER2-Positive Metastatic Breast CancerLu D, Joshi A, Wang B, Olsen S, Yi JH, Krop IE, Burris HA, Girish S. An Integrated Multiple-Analyte Pharmacokinetic Model to Characterize Trastuzumab Emtansine (T-DM1) Clearance Pathways and to Evaluate Reduced Pharmacokinetic Sampling in Patients with HER2-Positive Metastatic Breast Cancer. Clinical Pharmacokinetics 2013, 52: 657-672. PMID: 23553425, DOI: 10.1007/s40262-013-0060-y.
Preclinical and Clinical Studies of Gamma Secretase Inhibitors with Docetaxel on Human Breast TumorsSchott AF, Landis MD, Dontu G, Griffith KA, Layman RM, Krop I, Paskett LA, Wong H, Dobrolecki LE, Lewis MT, Froehlich AM, Paranilam J, Hayes DF, Wicha MS, Chang JC. Preclinical and Clinical Studies of Gamma Secretase Inhibitors with Docetaxel on Human Breast Tumors. Clinical Cancer Research 2013, 19: 1512-1524. PMID: 23340294, PMCID: PMC3602220, DOI: 10.1158/1078-0432.ccr-11-3326.
Beyond trastuzumab and lapatinib: new options for HER2-positive breast cancer .Zardavas D, Cameron D, Krop I, Piccart M. Beyond trastuzumab and lapatinib: new options for HER2-positive breast cancer . American Society Of Clinical Oncology Educational Book 2013, 33: e2-e11. PMID: 23714441, DOI: 10.1200/edbook_am.2013.33.e2.
Abstract P5-18-06: Trastuzumab emtansine in HER2-positive metastatic breast cancer: pooled safety analysis from seven studiesDiéras V, Harbeck N, Budd G, Greenson J, Guardino E, Samant M, Chernyukhin N, Smitt M, Krop I. Abstract P5-18-06: Trastuzumab emtansine in HER2-positive metastatic breast cancer: pooled safety analysis from seven studies. Cancer Research 2012, 72: p5-18-06-p5-18-06. DOI: 10.1158/0008-5472.sabcs12-p5-18-06.
Abstract OT1-1-11: TBCRC 022: Phase II Trial of Neratinib for Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast cancer and Brain MetastasesFreedman R, Gelman R, Wefel J, Krop I, Melisko M, Ly A, Agar N, Connolly R, Blackwell K, Nabell L, Ingle J, Van Poznak C, Puhalla S, Niravath P, Ryabin N, Wolff A, Winer E, Lin N. Abstract OT1-1-11: TBCRC 022: Phase II Trial of Neratinib for Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast cancer and Brain Metastases. Cancer Research 2012, 72: ot1-1-11-ot1-1-11. DOI: 10.1158/0008-5472.sabcs12-ot1-1-11.
Abstract P3-05-03: Characterization of PIK3CA mutations in lobular breast cancerDesmedt C, Metzger O, Fumagalli D, Brown D, Singhal S, Vincent D, Adnet P, Smeets D, Bertucci F, Galant C, Salgado R, Veys I, Saini K, Pruneri G, Krop I, Winer E, Michiels S, Piccart M, Lambrechts D, Larsimont D, Viale G, Sotiriou C. Abstract P3-05-03: Characterization of PIK3CA mutations in lobular breast cancer. Cancer Research 2012, 72: p3-05-03-p3-05-03. DOI: 10.1158/0008-5472.sabcs12-p3-05-03.
Abstract P5-18-03: Clinicopathological features among patients with HER2-positive breast cancer with prolonged response to trastuzumab based therapyVaz-Luis I, Seah D, Olson E, Metzger O, Wagle N, Sohl J, Litsas G, Burstein H, Krop I, Winer E, Lin N. Abstract P5-18-03: Clinicopathological features among patients with HER2-positive breast cancer with prolonged response to trastuzumab based therapy. Cancer Research 2012, 72: p5-18-03-p5-18-03. DOI: 10.1158/0008-5472.sabcs12-p5-18-03.
Trastuzumab Emtansine (T-DM1) for the Treatment of HER2-Positive Cancer with a Focus on Breast CancerRugo H, Krop I, Chu Y. Trastuzumab Emtansine (T-DM1) for the Treatment of HER2-Positive Cancer with a Focus on Breast Cancer. 2012, 179-210. DOI: 10.1007/978-1-4614-5456-4_11.
Trastuzumab Emtansine for HER2-Positive Advanced Breast CancerVerma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. New England Journal Of Medicine 2012, 367: 1783-1791. PMID: 23020162, PMCID: PMC5125250, DOI: 10.1056/nejmoa1209124.
Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.Pegram M, Blackwell K, Miles D, Bianchi G, Krop I, Welslau M, Baselga J, Oh D, Dieras V, Guardino E, Olsen S, Fang L, Lu M, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: 98-98. DOI: 10.1200/jco.2012.30.27_suppl.98.
LBA12 Results from Emilia, A Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine (X) and Lapatinib (L) in Her2-Positive Locally Advanced or Metastatic Breast Cancer (MBC)Verma S, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Diéras V, Guardino E, Fang L, Lu M, Olsen S, Blackwell K. LBA12 Results from Emilia, A Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine (X) and Lapatinib (L) in Her2-Positive Locally Advanced or Metastatic Breast Cancer (MBC). Annals Of Oncology 2012, 23: ixe5-ixe6. DOI: 10.1016/s0923-7534(20)34362-3.
A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancerBender BC, Schaedeli-Stark F, Koch R, Joshi A, Chu YW, Rugo H, Krop IE, Girish S, Friberg LE, Gupta M. A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemotherapy And Pharmacology 2012, 70: 591-601. PMID: 22886072, DOI: 10.1007/s00280-012-1934-7.
Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.Blackwell K, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Dieras V, Olsen S, Fang L, Lu M, Guardino E, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: lba1-lba1. DOI: 10.1200/jco.2012.30.18_suppl.lba1.
A phase 1 study of weekly dosing of trastuzumab emtansine (T‐DM1) in patients with advanced human epidermal growth factor 2–positive breast cancerBeeram M, Krop IE, Burris HA, Girish SR, Yu W, Lu MW, Holden SN, Modi S. A phase 1 study of weekly dosing of trastuzumab emtansine (T‐DM1) in patients with advanced human epidermal growth factor 2–positive breast cancer. Cancer 2012, 118: 5733-5740. PMID: 22648179, DOI: 10.1002/cncr.27622.
A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and CapecitabineKrop IE, LoRusso P, Miller KD, Modi S, Yardley D, Rodriguez G, Guardino E, Lu M, Zheng M, Girish S, Amler L, Winer EP, Rugo HS. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. Journal Of Clinical Oncology 2012, 30: 3234-3241. PMID: 22649126, DOI: 10.1200/jco.2011.40.5902.
A phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense (dd) doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC).Tolaney S, Duda D, Boucher Y, Goel S, Martin J, Ancukiewicz M, Potler H, Incio J, Ligibel J, Isakoff S, Fukumura D, Winer E, Krop I, Jain R. A phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense (dd) doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC). Journal Of Clinical Oncology 2012, 30: 1026-1026. DOI: 10.1200/jco.2012.30.15_suppl.1026.
Evaluation of gene expression by RNA-seq after single dose of trastuzumab (T) reveals predictors of pathologic complete response (pCR) in HER2-positive early breast cancer.Galanina N, Sprecher E, Bossuyt V, Sarkar S, Krop I, Winer E, Tuck D, Bruce C, Harris L. Evaluation of gene expression by RNA-seq after single dose of trastuzumab (T) reveals predictors of pathologic complete response (pCR) in HER2-positive early breast cancer. Journal Of Clinical Oncology 2012, 30: 10558-10558. DOI: 10.1200/jco.2012.30.15_suppl.10558.
A phase I/IB dose-escalation study of BEZ235 in combination with trastuzumab in patients with PI3-kinase or PTEN altered HER2+ metastatic breast cancer.Krop I, Saura C, Rodon Ahnert J, Becerra C, Britten C, Isakoff S, Demanse D, Hackl W, Quadt C, Silva A, Burris H, Abu-Khalaf M, Baselga J. A phase I/IB dose-escalation study of BEZ235 in combination with trastuzumab in patients with PI3-kinase or PTEN altered HER2+ metastatic breast cancer. Journal Of Clinical Oncology 2012, 30: 508-508. DOI: 10.1200/jco.2012.30.15_suppl.508.
Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.
Cardiac safety in a phase II study of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as adjuvant or neoadjuvant therapy for early-stage HER2-positive breast cancer.Dang C, Gianni L, Romieu G, Dirix L, Campone M, Citron M, Zamagni C, Krop I, Xu N, Smitt M, Suter T. Cardiac safety in a phase II study of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as adjuvant or neoadjuvant therapy for early-stage HER2-positive breast cancer. Journal Of Clinical Oncology 2012, 30: 532-532. DOI: 10.1200/jco.2012.30.15_suppl.532.
Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.Blackwell K, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Dieras V, Olsen S, Fang L, Lu M, Guardino E, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: lba1-lba1. DOI: 10.1200/jco.2012.30.15_suppl.lba1.
A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer.Munster P, Miller K, Krop I, Dhindsa N, Reynolds J, Geretti E, Niyikiza C, Nielsen U, Hendriks B, Wickham T, Moyo V, LoRusso P. A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer. Journal Of Clinical Oncology 2012, 30: tps663-tps663. DOI: 10.1200/jco.2012.30.15_suppl.tps663.
Phase I Pharmacologic and Pharmacodynamic Study of the Gamma Secretase (Notch) Inhibitor MK-0752 in Adult Patients With Advanced Solid TumorsKrop I, Demuth T, Guthrie T, Wen PY, Mason WP, Chinnaiyan P, Butowski N, Groves MD, Kesari S, Freedman SJ, Blackman S, Watters J, Loboda A, Podtelezhnikov A, Lunceford J, Chen C, Giannotti M, Hing J, Beckman R, LoRusso P. Phase I Pharmacologic and Pharmacodynamic Study of the Gamma Secretase (Notch) Inhibitor MK-0752 in Adult Patients With Advanced Solid Tumors. Journal Of Clinical Oncology 2012, 30: 2307-2313. PMID: 22547604, DOI: 10.1200/jco.2011.39.1540.
Abstract LB-231: Phase Ib dose escalation and biomarker study of MK2206 in combination with standard doses of weekly paclitaxel in patients with locally advanced or metastatic solid tumors with expansion in advanced breast cancerGonzalez-Angulo A, Krop I, Piha-Paul S, Li Y, Culotta K, Moulder-Thompson S, Tsimberidou A, Velez-Bravo V, Madden T, Norberg L, Doyle A, Winder E, Mills G, Meric-Bernstam F, Kurzrock R. Abstract LB-231: Phase Ib dose escalation and biomarker study of MK2206 in combination with standard doses of weekly paclitaxel in patients with locally advanced or metastatic solid tumors with expansion in advanced breast cancer. Cancer Research 2012, 72: lb-231-lb-231. DOI: 10.1158/1538-7445.am2012-lb-231.
1st International consensus guidelines for advanced breast cancer (ABC 1)Cardoso F, Costa A, Norton L, Cameron D, Cufer T, Fallowfield L, Francis P, Gligorov J, Kyriakides S, Lin N, Pagani O, Senkus E, Thomssen C, Aapro M, Bergh J, Di Leo A, Saghir N, Ganz P, Gelmon K, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Leadbeater M, Mayer M, Rodger A, Rugo H, Sacchini V, Sledge G, Veer L, Viale G, Krop I, Winer E. 1st International consensus guidelines for advanced breast cancer (ABC 1). The Breast 2012, 21: 242-252. PMID: 22425534, DOI: 10.1016/j.breast.2012.03.003.
Doubling Down on Human Epidermal Growth Factor Receptor 2Krop I. Doubling Down on Human Epidermal Growth Factor Receptor 2. Journal Of Clinical Oncology 2012, 30: 1574-1576. PMID: 22393081, DOI: 10.1200/jco.2011.40.1463.
E6. Can an international consensus meeting change the future of advanced breast cancer patients? Highlights from ABC1 Consensus MeetingCardoso F, Winer E, Norton L, Gomis R, Krop I, Harbeck N, Costa A. E6. Can an international consensus meeting change the future of advanced breast cancer patients? Highlights from ABC1 Consensus Meeting. European Journal Of Cancer 2012, 48: s13-s14. DOI: 10.1016/s0959-8049(12)70057-6.
Phase I safety, pharmacokinetic, and pharmacodynamic study of the oral phosphatidylinositol-3-kinase and mTOR inhibitor BGT226 in patients with advanced solid tumorsMarkman B, Tabernero J, Krop I, Shapiro G, Siu L, Chen L, Mita M, Cuero M, Stutvoet S, Birle D, Anak Ö, Hackl W, Baselga J. Phase I safety, pharmacokinetic, and pharmacodynamic study of the oral phosphatidylinositol-3-kinase and mTOR inhibitor BGT226 in patients with advanced solid tumors. Annals Of Oncology 2012, 23: 2399-2408. PMID: 22357447, DOI: 10.1093/annonc/mds011.
Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody–drug conjugate in development for the treatment of HER2-positive cancerGirish S, Gupta M, Wang B, Lu D, Krop IE, Vogel CL, Burris III HA, LoRusso PM, Yi JH, Saad O, Tong B, Chu YW, Holden S, Joshi A. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody–drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemotherapy And Pharmacology 2012, 69: 1229-1240. PMID: 22271209, PMCID: PMC3337408, DOI: 10.1007/s00280-011-1817-3.
Further progress in HER2-directed therapyKrop I, Winer EP. Further progress in HER2-directed therapy. The Lancet Oncology 2012, 13: 2-3. PMID: 22225715, DOI: 10.1016/s1470-2045(11)70388-6.
Improving therapy for HER2-positive cancers through neoadjuvant studies.Krop I. Improving therapy for HER2-positive cancers through neoadjuvant studies. Oncology 2012, 26: 34, 36. PMID: 22393794.
P1-09-03: Prevalence of Germline TP53 Mutations in Young Women with HER2−Positive Breast Cancer.Dick M, Masciari S, Miron A, Miron P, Foley K, Gelman R, Dillon D, Richardson A, Verselis S, Lypas G, Krop I, Garber J. P1-09-03: Prevalence of Germline TP53 Mutations in Young Women with HER2−Positive Breast Cancer. Cancer Research 2011, 71: p1-09-03-p1-09-03. DOI: 10.1158/0008-5472.sabcs11-p1-09-03.
P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer.Sprecher E, Lezon-Geyda K, Sarkar S, Bossuyt V, Narayaan M, Kumar A, Krop I, Winer E, Tuck D, Kleinstein S, Harris L. P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer. Cancer Research 2011, 71: p1-06-23-p1-06-23. DOI: 10.1158/0008-5472.sabcs11-p1-06-23.
P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen.Tolaney S, Burris H, Gartner E, Mayer I, Saura C, Maurer M, DeCillis A, Ruiz-Soto R, Lager J, Winer E, Krop I. P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen. Cancer Research 2011, 71: p1-17-02-p1-17-02. DOI: 10.1158/0008-5472.sabcs11-p1-17-02.
P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA).Dang C, Tolaney S, Najita J, Gelman R, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff A, Carey L, Vahdat L, Burdette-Radoux S, Budd T, Krop I, Burstein H, Hudis C, Winer E. P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA). Cancer Research 2011, 71: p2-18-02-p2-18-02. DOI: 10.1158/0008-5472.sabcs11-p2-18-02.
PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer.Olson E, Flores L, Najita J, Curley C, Jeong J, Murray K, Savoie J, Winer E, Krop I. PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer. Cancer Research 2011, 71: pd05-07-pd05-07. DOI: 10.1158/0008-5472.sabcs11-pd05-07.
PD09-04: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of the PI3-Kinase Inhibitor GDC-0941 in Combination with Paclitaxel and Bevacizumab in Patients with Locally Recurrent or Metastatic Breast Cancer.Schöffski P, De Benedictis E, Gendreau S, Gianni L, Krop I, Levy G, Ware J, Wildiers H, Winer E. PD09-04: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of the PI3-Kinase Inhibitor GDC-0941 in Combination with Paclitaxel and Bevacizumab in Patients with Locally Recurrent or Metastatic Breast Cancer. Cancer Research 2011, 71: pd09-04-pd09-04. DOI: 10.1158/0008-5472.sabcs11-pd09-04.
Use of discard pleural fluid in molecular researchOlson EM, Lin NU, Krop IE, Winer EP. Use of discard pleural fluid in molecular research. Nature Reviews Clinical Oncology 2011, 9: 64-64. PMID: 24222788, PMCID: PMC3821068, DOI: 10.1038/nrclinonc.2011.114-c2.
New and future therapies for HER-2+ advanced breast cancerKrop I. New and future therapies for HER-2+ advanced breast cancer. The Breast 2011, 20: s16. DOI: 10.1016/j.breast.2011.08.015.
The ethical use of mandatory research biopsiesOlson EM, Lin NU, Krop IE, Winer EP. The ethical use of mandatory research biopsies. Nature Reviews Clinical Oncology 2011, 8: 620-625. PMID: 21808265, PMCID: PMC3632075, DOI: 10.1038/nrclinonc.2011.114.
Association between response to brief trastuzumab exposure in cell lines and early stage HER2+ breast tumorsSprecher E, Sarkar S, Kleinstein S, Narayan M, Winer E, Tuck D, Lezon-Geyda K, Krop I, Harris L. Association between response to brief trastuzumab exposure in cell lines and early stage HER2+ breast tumors. 2011, 446-450. DOI: 10.1145/2147805.2147867.
Phase I/II Study of Trastuzumab in Combination With Everolimus (RAD001) in Patients With HER2-Overexpressing Metastatic Breast Cancer Who Progressed on Trastuzumab-Based TherapyMorrow PK, Wulf GM, Ensor J, Booser DJ, Moore JA, Flores PR, Xiong Y, Zhang S, Krop IE, Winer EP, Kindelberger DW, Coviello J, Sahin AA, Nuñez R, Hortobagyi GN, Yu D, Esteva FJ. Phase I/II Study of Trastuzumab in Combination With Everolimus (RAD001) in Patients With HER2-Overexpressing Metastatic Breast Cancer Who Progressed on Trastuzumab-Based Therapy. Journal Of Clinical Oncology 2011, 29: 3126-3132. PMID: 21730275, PMCID: PMC3157979, DOI: 10.1200/jco.2010.32.2321.
A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain MetastasesFreedman RA, Bullitt E, Sun L, Gelman R, Harris G, Ligibel JA, Krop IE, Partridge AH, Eisenberg E, Winer EP, Lin NU. A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases. Clinical Breast Cancer 2011, 11: 376-383. PMID: 21697017, PMCID: PMC3773692, DOI: 10.1016/j.clbc.2011.03.024.
A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC.Bender B, Schaedeli Stark F, Joshi A, Chu Y, Rugo H, Krop I, Girish S, Gupta M. A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC. Journal Of Clinical Oncology 2011, 29: 605-605. DOI: 10.1200/jco.2011.29.15_suppl.605.
TBCRC 003: Phase II trial of trastuzumab (T) and lapatinib (L) in patients (pts) with HER2+ metastatic breast cancer (MBC).Lin N, Mayer I, Najita J, Hobday T, Falkson C, Dees E, Rimawi M, Nanda R, Gelman R, Josephs K, Richardson A, Flores L, Van Den Abbeele A, Yap J, Arteaga C, Wolff A, Krop I, Winer E. TBCRC 003: Phase II trial of trastuzumab (T) and lapatinib (L) in patients (pts) with HER2+ metastatic breast cancer (MBC). Journal Of Clinical Oncology 2011, 29: 527-527. DOI: 10.1200/jco.2011.29.15_suppl.527.
The role of EGFR amplification in trastuzumab resistance: A correlative analysis of TBCRC003.Krop I, Flores L, Najita J, Mayer I, Hobday T, Falkson C, Arteaga C, Wolff A, Dees E, Rimawi M, Nanda R, Josephs K, Lin N, Winer E. The role of EGFR amplification in trastuzumab resistance: A correlative analysis of TBCRC003. Journal Of Clinical Oncology 2011, 29: 528-528. DOI: 10.1200/jco.2011.29.15_suppl.528.
Ribavirin Treatment Effects on Breast Cancers Overexpressing eIF4E, a Biomarker with Prognostic Specificity for Luminal B-Type Breast CancerPettersson F, Yau C, Dobocan MC, Culjkovic-Kraljacic B, Retrouvay H, Puckett R, Flores LM, Krop IE, Rousseau C, Cocolakis E, Borden KL, Benz CC, Miller WH. Ribavirin Treatment Effects on Breast Cancers Overexpressing eIF4E, a Biomarker with Prognostic Specificity for Luminal B-Type Breast Cancer. Clinical Cancer Research 2011, 17: 2874-2884. PMID: 21415224, PMCID: PMC3086959, DOI: 10.1158/1078-0432.ccr-10-2334.
Responses to subsequent anti-HER2 therapy after treatment with trastuzumab-DM1 in women with HER2-positive metastatic breast cancerOlson EM, Lin NU, DiPiro PJ, Najita JS, Krop IE, Winer EP, Burstein HJ. Responses to subsequent anti-HER2 therapy after treatment with trastuzumab-DM1 in women with HER2-positive metastatic breast cancer. Annals Of Oncology 2011, 23: 93-97. PMID: 21531783, PMCID: PMC3276325, DOI: 10.1093/annonc/mdr061.
Abstract 4719: Dynamic changes in gene expression after one dose of trastuzumab (T) reveal novel biomarkers of response to combination therapy in HER2 positive early stage breast cancerHarris L, Sprecher E, Wei-Gu L, Lezon-Geyda K, Sakar S, Krop I, Winer E, Tuck D. Abstract 4719: Dynamic changes in gene expression after one dose of trastuzumab (T) reveal novel biomarkers of response to combination therapy in HER2 positive early stage breast cancer. Cancer Research 2011, 71: 4719-4719. DOI: 10.1158/1538-7445.am2011-4719.
GPHMM: an integrated hidden Markov model for identification of copy number alteration and loss of heterozygosity in complex tumor samples using whole genome SNP arraysLi A, Liu Z, Lezon-Geyda K, Sarkar S, Lannin D, Schulz V, Krop I, Winer E, Harris L, Tuck D. GPHMM: an integrated hidden Markov model for identification of copy number alteration and loss of heterozygosity in complex tumor samples using whole genome SNP arrays. Nucleic Acids Research 2011, 39: 4928-4941. PMID: 21398628, PMCID: PMC3130254, DOI: 10.1093/nar/gkr014.
Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed TherapyBurris HA, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, Tan-Chiu E, Krop IE, Michaelson RA, Girish S, Amler L, Zheng M, Chu YW, Klencke B, O'Shaughnessy JA. Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy. Journal Of Clinical Oncology 2010, 29: 398-405. PMID: 21172893, DOI: 10.1200/jco.2010.29.5865.
Abstract P3-14-10: A Dose-Escalation Study of Trastuzumab-DM1 (T-DM1), Paclitaxel (T), and Pertuzumab (P) in Patients with HER2-Positive, Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing RegimenKrop I, Modi S, Elias A, LoRusso P, Choi Y, Lu M. Abstract P3-14-10: A Dose-Escalation Study of Trastuzumab-DM1 (T-DM1), Paclitaxel (T), and Pertuzumab (P) in Patients with HER2-Positive, Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing Regimen. Cancer Research 2010, 70: p3-14-10-p3-14-10. DOI: 10.1158/0008-5472.sabcs10-p3-14-10.
Abstract P3-14-22: Pharmacokinetics (PK) of Trastuzumab-DM1 (T-DM1) and Paclitaxel (T) in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing RegimenLu D, Krop I, Modi S, Elias A, LoRusso P, Huang J, Lu M, Girish S. Abstract P3-14-22: Pharmacokinetics (PK) of Trastuzumab-DM1 (T-DM1) and Paclitaxel (T) in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing Regimen. Cancer Research 2010, 70: p3-14-22-p3-14-22. DOI: 10.1158/0008-5472.sabcs10-p3-14-22.
Abstract P6-15-03: Phase Ib Trial of the Gamma Secretase Inhibitor (GSI), MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast CancerSchott A, Chang J, Krop I, Griffith K, Layman R, Hayes D, Wicha M. Abstract P6-15-03: Phase Ib Trial of the Gamma Secretase Inhibitor (GSI), MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast Cancer. Cancer Research 2010, 70: p6-15-03-p6-15-03. DOI: 10.1158/0008-5472.sabcs10-p6-15-03.
Abstract P3-14-08: Responses to Subsequent Anti-HER2 Therapy after Treatment with Trastuzumab-DM1 in Women with HER2-Positive Metastatic Breast CancerOlson E, Lin N, DiPiro P, Najita J, Krop I, Winer E, Burstein H. Abstract P3-14-08: Responses to Subsequent Anti-HER2 Therapy after Treatment with Trastuzumab-DM1 in Women with HER2-Positive Metastatic Breast Cancer. Cancer Research 2010, 70: p3-14-08-p3-14-08. DOI: 10.1158/0008-5472.sabcs10-p3-14-08.
Abstract P6-15-02: A Phase Ib Study Evaluating Safety, Tolerability, Pharmacokinetics (PK), and Activity of the Phosphoinositide-3 Kinase (PI3K) Inhibitor GDC-0941 in Combination with Trastuzumab-MCC-DM1 (T-DM1) in Patients with Advanced HER2-Positive Breast CancerKrop I, Wolff A, Winer E, Miller K, Park B, Ware J, Holden S, Levy G, Derynck M, Storniolo A. Abstract P6-15-02: A Phase Ib Study Evaluating Safety, Tolerability, Pharmacokinetics (PK), and Activity of the Phosphoinositide-3 Kinase (PI3K) Inhibitor GDC-0941 in Combination with Trastuzumab-MCC-DM1 (T-DM1) in Patients with Advanced HER2-Positive Breast Cancer. Cancer Research 2010, 70: p6-15-02-p6-15-02. DOI: 10.1158/0008-5472.sabcs10-p6-15-02.
Abstract PD07-08: Integrated Genomic Analysis before and after Brief Exposure to Trastuzumab (T): The11q13 and 17q12 Amplicons Are Associated with Response to T+Chemotherapy in Early Stage HER2 Positive Breast CancerHarris L, Liu Z, Li A, Sprecher E, Sarkar S, Lezon-Geyda K, Krop I, Winer E, Tuck D. Abstract PD07-08: Integrated Genomic Analysis before and after Brief Exposure to Trastuzumab (T): The11q13 and 17q12 Amplicons Are Associated with Response to T+Chemotherapy in Early Stage HER2 Positive Breast Cancer. Cancer Research 2010, 70: pd07-08-pd07-08. DOI: 10.1158/0008-5472.sabcs10-pd07-08.
Advances in Targeting Src in the Treatment of Breast Cancer and Other Solid MalignanciesMayer EL, Krop IE. Advances in Targeting Src in the Treatment of Breast Cancer and Other Solid Malignancies. Clinical Cancer Research 2010, 16: 3526-3532. PMID: 20634194, DOI: 10.1158/1078-0432.ccr-09-1834.
Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy.LoRusso P, Krop I, Burris H, Vukelja S, Miller K, Zheng M, Chu Y, Lu M, Amler L, Rugo H. Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy. Journal Of Clinical Oncology 2010, 28: 1016-1016. DOI: 10.1200/jco.2010.28.15_suppl.1016.
Phase I/II trial of everolimus (RAD001) and trastuzumab in patients with trastuzumab-resistant, HER2-overexpressing breast cancer.Morrow P, Wulf G, Booser D, Moore J, Flores P, Krop I, Winer E, Hortobagyi G, Yu D, Esteva F. Phase I/II trial of everolimus (RAD001) and trastuzumab in patients with trastuzumab-resistant, HER2-overexpressing breast cancer. Journal Of Clinical Oncology 2010, 28: 1014-1014. DOI: 10.1200/jco.2010.28.15_suppl.1014.
Phase II trial of preoperative vinorelbine/trastuzumab (VH) or docetaxel/carboplatin/trastuzumab (TCH) in HER2-positive breast cancer with analysis of resistance mechanisms.Krop I, Flores L, Tuck D, Ryan P, Partridge A, Morganstern D, Najita J, lezon-Geyda K, Winer E, Harris L. Phase II trial of preoperative vinorelbine/trastuzumab (VH) or docetaxel/carboplatin/trastuzumab (TCH) in HER2-positive breast cancer with analysis of resistance mechanisms. Journal Of Clinical Oncology 2010, 28: 549-549. DOI: 10.1200/jco.2010.28.15_suppl.549.
TBCRC 003: Phase II trial of trastuzumab (T) and lapatinib (L) in patients (pts) with HER2+ metastatic breast cancer (MBC).Lin N, Mayer I, Hobday T, Falkson C, Dees E, Nanda R, Krop I, Rimawi M, Wolff A, Winer E. TBCRC 003: Phase II trial of trastuzumab (T) and lapatinib (L) in patients (pts) with HER2+ metastatic breast cancer (MBC). Journal Of Clinical Oncology 2010, 28: tps132-tps132. DOI: 10.1200/jco.2010.28.15_suppl.tps132.
Improving the yield of circulating tumour cells facilitates molecular characterisation and recognition of discordant HER2 amplification in breast cancerFlores LM, Kindelberger DW, Ligon AH, Capelletti M, Fiorentino M, Loda M, Cibas ES, Jänne PA, Krop IE. Improving the yield of circulating tumour cells facilitates molecular characterisation and recognition of discordant HER2 amplification in breast cancer. British Journal Of Cancer 2010, 102: 1495-1502. PMID: 20461092, PMCID: PMC2869174, DOI: 10.1038/sj.bjc.6605676.
Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast CancerKrop IE, Beeram M, Modi S, Jones SF, Holden SN, Yu W, Girish S, Tibbitts J, Yi JH, Sliwkowski MX, Jacobson F, Lutzker SG, Burris HA. Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer. Journal Of Clinical Oncology 2010, 28: 2698-2704. PMID: 20421541, DOI: 10.1200/jco.2009.26.2071.
Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in OncologyPeppercorn J, Shapira I, Collyar D, Deshields T, Lin N, Krop I, Grunwald H, Friedman P, Partridge AH, Schilsky RL, Bertagnolli MM. Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology. Journal Of Clinical Oncology 2010, 28: 2635-2640. PMID: 20406927, PMCID: PMC5596502, DOI: 10.1200/jco.2009.27.2443.
Disruption of Laminin-Integrin-CD151-Focal Adhesion Kinase Axis Sensitizes Breast Cancer Cells to ErbB2 AntagonistsYang XH, Flores LM, Li Q, Zhou P, Xu F, Krop IE, Hemler ME. Disruption of Laminin-Integrin-CD151-Focal Adhesion Kinase Axis Sensitizes Breast Cancer Cells to ErbB2 Antagonists. Cancer Research 2010, 70: 2256-2263. PMID: 20197472, PMCID: PMC3310185, DOI: 10.1158/0008-5472.can-09-4032.
Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization.Flores L, Kindelberger D, Ligon A, Cappeletti M, Fiorentino M, Loda M, Cibas E, Janne P, Krop I. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. Cancer Research 2009, 69: 3003-3003. DOI: 10.1158/0008-5472.sabcs-09-3003.
A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody–Drug Conjugate, in HER2+ Metastatic Breast Cancer (MBC) Patients Previously Treated with Conventional Chemotherapy, Lapatinib and Trastuzumab.Krop I, LoRusso P, Miller K, Modi S, Yardley D, Rodriguez G, Agresta S, Zheng M, Amler L, Rugo H. A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody–Drug Conjugate, in HER2+ Metastatic Breast Cancer (MBC) Patients Previously Treated with Conventional Chemotherapy, Lapatinib and Trastuzumab. Cancer Research 2009, 69: 5090-5090. DOI: 10.1158/0008-5472.sabcs-09-5090.
5020 Pharmacokinetics (PK), safety, and efficacy of trastuzumab (T)-DM1, a HER2 antibody-drug conjugate (ADC), in patients with HER2+ metastatic breast cancer (MBC): phase I and phase II trial resultsBurris H, Vukelja S, Krop I, Modi S, Klencke B, Girish S, Sliwkowski M, Dresser M, Phillips G, Rugo H. 5020 Pharmacokinetics (PK), safety, and efficacy of trastuzumab (T)-DM1, a HER2 antibody-drug conjugate (ADC), in patients with HER2+ metastatic breast cancer (MBC): phase I and phase II trial results. European Journal Of Cancer Supplements 2009, 7: 266-267. DOI: 10.1016/s1359-6349(09)70912-7.
Personalizing treatment in early-stage breast cancer: The role of standard clinical factors and genomic information in adjuvant chemotherapy decision makingGold J, Najita J, Lester S, Richardson A, Morganstern D, Chen W, Partridge A, Krop I, Winer E, Burstein H. Personalizing treatment in early-stage breast cancer: The role of standard clinical factors and genomic information in adjuvant chemotherapy decision making. Journal Of Clinical Oncology 2009, 27: 572-572. DOI: 10.1200/jco.2009.27.15_suppl.572.
Quantitative assessment of HER2 status and correlation with efficacy for patients (pts) with metastatic breast cancer (MBC) in a phase II study of trastuzumab-DM1 (T-DM1)Krop I, Burris H, Rugo H, O'Shaughnessy J, Vogel C, Amler L, Strauss A, Wong E, Klencke B, Pippen J. Quantitative assessment of HER2 status and correlation with efficacy for patients (pts) with metastatic breast cancer (MBC) in a phase II study of trastuzumab-DM1 (T-DM1). Journal Of Clinical Oncology 2009, 27: 1003-1003. DOI: 10.1200/jco.2009.27.15_suppl.1003.
Mechanisms of trastuzumab resistance in breast cancer.Tolaney SM, Krop IE. Mechanisms of trastuzumab resistance in breast cancer. Anti-Cancer Agents In Medicinal Chemistry 2009, 9: 348-55. PMID: 19275526, DOI: 10.2174/1871520610909030348.
A phase II study of oral enzastaurin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane containing regimenMina L, Krop I, Zon RT, Isakoff SJ, Schneider CJ, Yu M, Johnson C, Vaughn LG, Wang Y, Hristova-Kazmierski M, Shonukan OO, Sledge GW, Miller KD. A phase II study of oral enzastaurin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane containing regimen. Investigational New Drugs 2009, 27: 565. PMID: 19214387, DOI: 10.1007/s10637-009-9220-1.
Managing trastuzumab-resistant breast cancer.Krop I. Managing trastuzumab-resistant breast cancer. Clinical Advances In Hematology And Oncology 2009, 7: 108-10. PMID: 19367251.
A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer.Krop I, Mita M, Burris H, Birkner M, Girish S, Tibbitts J, Holden S, Lutzker S, Modi S. A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer. Cancer Research 2009, 69: 3136. DOI: 10.1158/0008-5472.sabcs-3136.
A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer.Tolaney S, Najita J, Chen W, Savoie J, Fornier M, Krop I, Winer E, Bunnell C. A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer. Cancer Research 2009, 69: 3137. DOI: 10.1158/0008-5472.sabcs-3137.
Epithelial and Stromal Cathepsin K and CXCL14 Expression in Breast Tumor ProgressionKleer CG, Bloushtain-Qimron N, Chen YH, Carrasco D, Hu M, Yao J, Kraeft SK, Collins LC, Sabel MS, Argani P, Gelman R, Schnitt SJ, Krop IE, Polyak K. Epithelial and Stromal Cathepsin K and CXCL14 Expression in Breast Tumor Progression. Clinical Cancer Research 2008, 14: 5357-5367. PMID: 18765527, PMCID: PMC2630242, DOI: 10.1158/1078-0432.ccr-08-0732.
Identification of novel HER2 splice variants in breast cancerBorras A, Rogers A, Kuang Y, Flores L, Distel R, Krop I. Identification of novel HER2 splice variants in breast cancer. Journal Of Clinical Oncology 2008, 26: 22010-22010. DOI: 10.1200/jco.2008.26.15_suppl.22010.
A phase I study of trastuzumab-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with advanced HER2+ breast cancer (BC)Beeram M, Burris H, Modi S, Birkner M, Girish S, Tibbitts J, Holden S, Lutzker S, Krop I. A phase I study of trastuzumab-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with advanced HER2+ breast cancer (BC). Journal Of Clinical Oncology 2008, 26: 1028-1028. DOI: 10.1200/jco.2008.26.15_suppl.1028.
A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients (pts) with advanced HER2+ breast cancer (BC)Holden S, Beeram M, Krop I, Burris H, Birkner M, Girish S, Tibbitts J, Lutzker S, Modi S. A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients (pts) with advanced HER2+ breast cancer (BC). Journal Of Clinical Oncology 2008, 26: 1029-1029. DOI: 10.1200/jco.2008.26.15_suppl.1029.
A phase II study of oral enzastaurin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane-containing regimen: HOG BRE05–97Krop I, Miller K, Zon R, Isakoff S, Schneider C, Yu M, Johnson C, Vaughn L, Shonukan O, Sledge G. A phase II study of oral enzastaurin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane-containing regimen: HOG BRE05–97. Journal Of Clinical Oncology 2008, 26: 1004-1004. DOI: 10.1200/jco.2008.26.15_suppl.1004.
Ten years of HER2-directed therapy: still questions after all these yearsKrop IE, Winer EP. Ten years of HER2-directed therapy: still questions after all these years. Breast Cancer Research And Treatment 2008, 113: 207-209. PMID: 18463974, DOI: 10.1007/s10549-008-0041-2.
Short Preoperative Treatment With Erlotinib Inhibits Tumor Cell Proliferation in Hormone Receptor–Positive Breast CancersGuix M, de Matos Granja N, Meszoely I, Adkins TB, Wieman BM, Frierson KE, Sanchez V, Sanders ME, Grau AM, Mayer IA, Pestano G, Shyr Y, Muthuswamy S, Calvo B, Krontiras H, Krop IE, Kelley MC, Arteaga CL. Short Preoperative Treatment With Erlotinib Inhibits Tumor Cell Proliferation in Hormone Receptor–Positive Breast Cancers. Journal Of Clinical Oncology 2008, 26: 897-906. PMID: 18180460, DOI: 10.1200/jco.2007.13.5939.
2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancerKrop I, Beeram M, Modi S, Rabbee N, Girish S, Tibbitts J, Holden S, Lutzker S, Burris H. 2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer. European Journal Of Cancer Supplements 2007, 5: 219. DOI: 10.1016/s1359-6349(07)70880-7.
Does MRI predict pathologic tumor response in women with breast cancer undergoing preoperative chemotherapy?Segara D, Krop IE, Garber JE, Winer E, Harris L, Bellon JR, Birdwell R, Lester S, Lipsitz S, Iglehart JD, Golshan M. Does MRI predict pathologic tumor response in women with breast cancer undergoing preoperative chemotherapy? Journal Of Surgical Oncology 2007, 96: 474-480. PMID: 17640031, DOI: 10.1002/jso.20856.
A phase I study of trastuzumab-MCC-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (BC)Beeram M, Krop I, Modi S, Tolcher A, Rabbee N, Girish S, Tibbitts J, Holden S, Lutzker S, Burris H. A phase I study of trastuzumab-MCC-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (BC). Journal Of Clinical Oncology 2007, 25: 1042-1042. DOI: 10.1200/jco.2007.25.18_suppl.1042.
Chemokine signaling in gliomas: Prognostic factor, Therapeutic target or both?Krop IE. Chemokine signaling in gliomas: Prognostic factor, Therapeutic target or both? Cancer Biology & Therapy 2006, 5: 1039-1041. PMID: 16931903, DOI: 10.4161/cbt.5.8.3021.
Phase I pharmacokinetic (PK), and pharmacodynamic (PD) trial of the novel oral Notch inhibitor MK-0752 in patients (pts) with advanced breast cancer (BC) and other solid tumorsKrop I, Kosh M, Fearen I, Savoie J, Dallob A, Matthews C, Stone J, Winer E, Freedman S, Lorusso P. Phase I pharmacokinetic (PK), and pharmacodynamic (PD) trial of the novel oral Notch inhibitor MK-0752 in patients (pts) with advanced breast cancer (BC) and other solid tumors. Journal Of Clinical Oncology 2006, 24: 10574-10574. DOI: 10.1200/jco.2006.24.18_suppl.10574.
Early Breast Cancer (Stage I and Stage II): Tailored Systemic Therapy for Endocrine-Responsive Breast CancerKrop I, Winer E. Early Breast Cancer (Stage I and Stage II): Tailored Systemic Therapy for Endocrine-Responsive Breast Cancer. 2006, 327-348. DOI: 10.1007/978-3-540-28266-2_17.
A Putative Role for Psoriasin in Breast Tumor ProgressionKrop I, März A, Carlsson H, Li X, Bloushtain-Qimron N, Hu M, Gelman R, Sabel MS, Schnitt S, Ramaswamy S, Kleer CG, Enerbäck C, Polyak K. A Putative Role for Psoriasin in Breast Tumor Progression. Cancer Research 2005, 65: 11326-11334. PMID: 16357139, DOI: 10.1158/0008-5472.can-05-1523.
HIN-1, an Inhibitor of Cell Growth, Invasion, and AKT ActivationKrop I, Parker MT, Bloushtain-Qimron N, Porter D, Gelman R, Sasaki H, Maurer M, Terry MB, Parsons R, Polyak K. HIN-1, an Inhibitor of Cell Growth, Invasion, and AKT Activation. Cancer Research 2005, 65: 9659-9669. PMID: 16266985, DOI: 10.1158/0008-5472.can-05-1663.
Ovarian Suppression for Breast Cancer: An Effective Treatment in Search of a HomeKrop IE, Winer EP. Ovarian Suppression for Breast Cancer: An Effective Treatment in Search of a Home. Journal Of Clinical Oncology 2005, 23: 5869-5872. PMID: 16087947, DOI: 10.1200/jco.2005.06.002.
HIN-1, an inhibitor of cell growth, invasion, and AKT1 activationKrop I, Parker M, Qimron N, Porter D, Polyak K. HIN-1, an inhibitor of cell growth, invasion, and AKT1 activation. Breast Cancer Research 2005, 7: p4.04. PMCID: PMC4233555, DOI: 10.1186/bcr1134.
Frequent HIN-1 promoter methylation and lack of expression in multiple human tumor types.Krop I, Player A, Tablante A, Taylor-Parker M, Lahti-Domenici J, Fukuoka J, Batra SK, Papadopoulos N, Richards WG, Sugarbaker DJ, Wright RL, Shim J, Stamey TA, Sellers WR, Loda M, Meyerson M, Hruban R, Jen J, Polyak K. Frequent HIN-1 promoter methylation and lack of expression in multiple human tumor types. Molecular Cancer Research 2004, 2: 489-94. PMID: 15383627, DOI: 10.1158/1541-7786.489.2.9.
Lack of HIN-1 methylation in BRCA1-linked and "BRCA1-like" breast tumors.Krop I, Maguire P, Lahti-Domenici J, Lodeiro G, Richardson A, Johannsdottir HK, Nevanlinna H, Borg A, Gelman R, Barkardottir RB, Lindblom A, Polyak K. Lack of HIN-1 methylation in BRCA1-linked and "BRCA1-like" breast tumors. Cancer Research 2003, 63: 2024-7. PMID: 12727813.
Novel estrogen and tamoxifen induced genes identified by SAGE (Serial Analysis of Gene Expression)Seth P, Krop I, Porter D, Polyak K. Novel estrogen and tamoxifen induced genes identified by SAGE (Serial Analysis of Gene Expression). Oncogene 2002, 21: 836-843. PMID: 11850811, DOI: 10.1038/sj.onc.1205113.
A SAGE (serial analysis of gene expression) view of breast tumor progression.Porter DA, Krop IE, Nasser S, Sgroi D, Kaelin CM, Marks JR, Riggins G, Polyak K. A SAGE (serial analysis of gene expression) view of breast tumor progression. Cancer Research 2001, 61: 5697-702. PMID: 11479200.
HIN-1, a putative cytokine highly expressed in normal but not cancerous mammary epithelial cellsKrop I, Sgroi D, Porter D, Lunetta K, LeVangie R, Seth P, Kaelin C, Rhei E, Bosenberg M, Schnitt S, Marks J, Pagon Z, Belina D, Razumovic J, Polyak K. HIN-1, a putative cytokine highly expressed in normal but not cancerous mammary epithelial cells. Proceedings Of The National Academy Of Sciences Of The United States Of America 2001, 98: 9796-9801. PMID: 11481438, PMCID: PMC55532, DOI: 10.1073/pnas.171138398.
Diagnostic dilemmas in oncology. Case 3. Metastatic ovarian cancer simulating colon cancer.Krop I, Wieczorek T, Mayer R. Diagnostic dilemmas in oncology. Case 3. Metastatic ovarian cancer simulating colon cancer. Journal Of Clinical Oncology 2000, 18: 3189-92. PMID: 10963649, DOI: 10.1200/jco.2000.18.17.3189.

Edit Profile

Ian Krop, MD, PhD

Contact Information

Patient Care

Research & Publications

Biography

News

Research Summary

Coauthors

Research Interests

Selected Publications