2021
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.Peer-Reviewed Original Research120MO 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
Fernandez-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.Peer-Reviewed Original Research331TiP HER2CLIMB-04: Phase II trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases
Carey 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.Peer-Reviewed Original ResearchLBA4 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
Bardia 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.Peer-Reviewed Original Research128TiP 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
Hamilton 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.Peer-Reviewed Original Research
2018
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.Peer-Reviewed Original Research
2017
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
Metzger 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.Peer-Reviewed Original Research
2016
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
Castan 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.Peer-Reviewed Original ResearchHERMIONE: 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.Peer-Reviewed Original Research
2015
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.Peer-Reviewed Original Research
2014
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.Peer-Reviewed Original ResearchPhase 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.Peer-Reviewed Original ResearchGene 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.Peer-Reviewed Original Research
2012
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.Peer-Reviewed Original ResearchPathologic complete responseSingle doseClinical trialsHER2-positive early breast cancerEarly breast cancer patientsEarly breast cancerBreast cancer patientsTumor core biopsiesSubsequent clinical trialsWeek time pointMost gene expression changesComplete responseCancer patientsPredictive markerCore biopsyBreast cancerImmune pathwaysTumorsTime pointsB2MGene expression changesBrief exposureHER2DoseTrials
2011
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.Peer-Reviewed Original Research
2010
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.Peer-Reviewed Original ResearchPhase 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.Peer-Reviewed Original Research
2009
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
Burris 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.Peer-Reviewed Original Research