2021
LBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB)
Hortobagyi G, Stemmer S, Burris H, Yap Y, Sonke G, Hart L, Campone M, Petrakova K, Winer E, Janni W, Conte P, Cameron D, André F, Arteaga C, Zarate J, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. LBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Annals Of Oncology 2021, 32: s1290-s1291. DOI: 10.1016/j.annonc.2021.08.2090.Peer-Reviewed Original ResearchImpact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab
Filho 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.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerHER2 heterogeneityBreast cancerEarly-stage HER2-positive breast cancerHER2-positive early-stage breast cancerTherapeutic resistancePathologic complete response rateEarly-stage breast cancerNeoadjuvant clinical trialsComplete response rateSubset of patientsHER2 therapyPretreatment biopsiesEvaluable casesCure rateT-DM1Trastuzumab emtansineClinical trialsTreatment strategiesTreatment responseTreatment selectionResponse rateRelated commentaryTherapyIssue feature
2020
Acquired FGFR and FGF Alterations Confer Resistance to Estrogen Receptor (ER) Targeted Therapy in ER+ Metastatic Breast Cancer
Mao P, Cohen O, Kowalski KJ, Kusiel JG, Buendia-Buendia JE, Cuoco MS, Exman P, Wander SA, Waks AG, Nayar U, Chung J, Freeman S, Rozenblatt-Rosen O, Miller VA, Piccioni F, Root DE, Regev A, Winer EP, Lin NU, Wagle N. Acquired FGFR and FGF Alterations Confer Resistance to Estrogen Receptor (ER) Targeted Therapy in ER+ Metastatic Breast Cancer. Clinical Cancer Research 2020, 26: 5974-5989. PMID: 32723837, DOI: 10.1158/1078-0432.ccr-19-3958.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBreast NeoplasmsCell Line, TumorDrug Resistance, NeoplasmExome SequencingFemaleFibroblast Growth Factor 3FulvestrantGene Expression Regulation, NeoplasticHumansMCF-7 CellsMiddle AgedMutationNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsPyridinesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 2Receptors, EstrogenXenograft Model Antitumor AssaysConceptsMetastatic breast cancerEstrogen receptorBreast cancerFGFR pathwaySelective estrogen receptor degraderCDK4/6 inhibitor palbociclibBreast cancer cellsMAPK pathwayWhole-exome sequencingResistant cell linesMAPK pathway inhibitorsFulvestrant resistanceInhibitor palbociclibDrug combinationsFGFR inhibitorsTherapyPathway inhibitorMEK inhibitorsConfer resistanceCancer cellsCancerInsulin receptorGenes/pathwaysBiopsyCell linesPALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Gnant M, DeMichele A, Martin M, Burstein H, Prat A, Rubovszky G, Miller K, Pfeiler G, Winer E, Zdenkowski N, Anderson D, Nowecki Z, Loibl S, Fohler H, Metzger O, Fumagalli D, Theall K, Fesl C, Dueck A. PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2020, 31: s1145. DOI: 10.1016/j.annonc.2020.08.2240.Peer-Reviewed Original Research
2019
A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC)
Bellon J, Chen Y, Rees R, Taghian A, Wong J, Punglia R, Shiloh R, Krishnan M, Andrews C, Isakoff S, Winer E, Tolaney S. A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC). International Journal Of Radiation Oncology • Biology • Physics 2019, 105: s43. DOI: 10.1016/j.ijrobp.2019.06.466.Peer-Reviewed Original ResearchSL 2.1 Adjuvant and neoadjuvant therapy in patients with early breast cancer: Principles and practical considerations
Winer E. SL 2.1 Adjuvant and neoadjuvant therapy in patients with early breast cancer: Principles and practical considerations. The Breast 2019, 44: s11. DOI: 10.1016/s0960-9776(19)30093-1.Peer-Reviewed Original Research
2018
Acquired HER2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor–directed therapies
Nayar U, Cohen O, Kapstad C, Cuoco MS, Waks AG, Wander SA, Painter C, Freeman S, Persky NS, Marini L, Helvie K, Oliver N, Rozenblatt-Rosen O, Ma CX, Regev A, Winer EP, Lin NU, Wagle N. Acquired HER2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor–directed therapies. Nature Genetics 2018, 51: 207-216. PMID: 30531871, DOI: 10.1038/s41588-018-0287-5.Peer-Reviewed Original ResearchConceptsHER2 mutationsEstrogen receptorBreast cancerClinical resistance mechanismsMainstay of treatmentMetastatic breast cancerReceptor-directed therapyCDK6 inhibitor palbociclibPre-existing mutationsMetastatic settingEstrogen independenceInhibitor palbociclibPrimary tumorMetastatic biopsiesInhibitor neratinibTherapyPatientsER mutationsCancerTamoxifenResistance mechanismsDistinct mechanismsMutationsConfer resistanceBiopsyCorrection to: De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017
Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, Colleoni M, Regan MM, Piccart-Gebhart M, Senn H, Thürlimann B, André F, Baselga J, Bergh J, Bonnefoi H, Brucker SY, Cardoso F, Carey L, Ciruelos E, Cuzick J, Denkert C, Di Leo A, Ejlertsen B, Francis P, Galimberti V, Garber J, Gulluoglu B, Goodwin P, Harbeck N, Hayes DF, Huang C, Huober J, Khaled H, Jassem J, Jiang Z, Karlsson P, Morrow M, Orecchia R, Osborne KC, Pagani O, Partridge AH, Pritchard K, Ro J, Rutgers EJT, Sedlmayer F, Semiglazov V, Shao Z, Smith I, Toi M, Tutt A, Viale G, Watanabe T, Whelan TJ, Xu B. Correction to: De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Annals Of Oncology 2018, 29: 2153. PMID: 29733336, PMCID: PMC6887963, DOI: 10.1093/annonc/mdx806.Peer-Reviewed Original Research369TiP 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 ResearchPalbociclib after CDK and endocrine therapy (PACE): A randomized phase II study of fulvestrant, palbociclib, and avelumab for endocrine pre-treated ER+/HER2- metastatic breast cancer.
Mayer E, Wander S, Regan M, DeMichele A, Forero-Torres A, Rimawi M, Ma C, Cristofanilli M, Anders C, Bartlett C, Winer E, Burstein H. Palbociclib after CDK and endocrine therapy (PACE): A randomized phase II study of fulvestrant, palbociclib, and avelumab for endocrine pre-treated ER+/HER2- metastatic breast cancer. Journal Of Clinical Oncology 2018, 36: tps1104-tps1104. DOI: 10.1200/jco.2018.36.15_suppl.tps1104.Peer-Reviewed Original ResearchABC trial (A011502): Randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for breast cancer.
Chen W, Winer E, Barry W, Partridge A, Carey L, Carvan M, Matyka C, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): Randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for breast cancer. Journal Of Clinical Oncology 2018, 36: tps597-tps597. DOI: 10.1200/jco.2018.36.15_suppl.tps597.Peer-Reviewed Original ResearchPredicting breast cancer therapeutic response
Garrido-Castro AC, Winer EP. Predicting breast cancer therapeutic response. Nature Medicine 2018, 24: 535-537. PMID: 29736021, DOI: 10.1038/s41591-018-0033-7.Peer-Reviewed Original Research69 Chemotherapy and HER2-Directed Therapy for Metastatic Breast Cancer
Waks A, Winer E. 69 Chemotherapy and HER2-Directed Therapy for Metastatic Breast Cancer. 2018, 885-906.e8. DOI: 10.1016/b978-0-323-35955-9.00069-6.Peer-Reviewed Original ResearchMetastatic breast cancerBreast cancerHER2-positive metastatic breast cancerTriple-negative breast cancerTriple-negative diseaseBRCA-deficient breast cancersUnderstanding of treatmentDistinct disease subtypesBrain metastasesOverall survivalSystemic therapyClinical efficacyNovel therapiesDisease subtypesTherapyCancerHER2ChemotherapyImportant advancesImmunotherapyPertuzumabPatientsMetastasisSubtypesDisease
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 Research215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Demichele A, Pfeiler G, Barry W, Metzger O, Rastogi P, Symmans F, Burstein H, Miller K, Loibl S, Schmatloch S, Goulioti T, Zardavas D, Fesl C, Koehler M, Bartlett C, Huang X, Piccart M, Winer E, Gnant M. 215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2017, 28: v66. DOI: 10.1093/annonc/mdx362.064.Peer-Reviewed Original ResearchGenomic Profiling in Node-Positive ER-Positive Early Breast Cancer: Can Tumor Biology Guide Locoregional Therapy?
Garrido-Castro AC, Winer EP. Genomic Profiling in Node-Positive ER-Positive Early Breast Cancer: Can Tumor Biology Guide Locoregional Therapy? Journal Of The National Cancer Institute 2017, 109: djw316. PMID: 28376163, DOI: 10.1093/jnci/djw316.Peer-Reviewed Original Research
2016
I-SPY 2 — Toward More Rapid Progress in Breast Cancer Treatment
Carey LA, Winer EP. I-SPY 2 — Toward More Rapid Progress in Breast Cancer Treatment. New England Journal Of Medicine 2016, 375: 83-84. PMID: 27406352, DOI: 10.1056/nejme1603691.Peer-Reviewed Original ResearchThe Metastatic Breast Cancer Project: A national direct-to-patient initiative to accelerate genomics research.
Wagle N, Painter C, Krevalin M, Oh C, Anderka K, Larkin K, Lennon N, Dillon D, Frank E, Winer E, Lander E, Golub T. The Metastatic Breast Cancer Project: A national direct-to-patient initiative to accelerate genomics research. Journal Of Clinical Oncology 2016, 34: lba1519-lba1519. DOI: 10.1200/jco.2016.34.18_suppl.lba1519.Peer-Reviewed Original ResearchMetastatic breast cancerBreast Cancer ProjectMedical recordsMedian timeBreast cancerDe novo metastatic breast cancerMedical providersCancer ProjectNovo metastatic breast cancerMedian ageInitial diagnosisTumor biopsiesMost tumorsSaliva kitsClinical informationNationwide studyExtraordinary responsePatient approachCommunity settingsTumorsPatient initiativeSaliva samplesTherapyGermline DNACancerA randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.
Goss P, Ingle J, Pritchard K, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff A, Winer E, Hudis C, Stopeck A, Beck J, Kaur J, Whelan K, Tu D, Parulekar W. A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer. Journal Of Clinical Oncology 2016, 34: lba1-lba1. DOI: 10.1200/jco.2016.34.15_suppl.lba1.Peer-Reviewed Original ResearchOvercoming Therapeutic Resistance in HER2-Positive Breast Cancers with CDK4/6 Inhibitors
Goel 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.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsBreast NeoplasmsCell Line, TumorCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Disease Models, AnimalDrug Resistance, NeoplasmErbB ReceptorsFemaleHumansMechanistic Target of Rapamycin Complex 1MiceMice, NudeMice, TransgenicMultiprotein ComplexesNeoplasm Recurrence, LocalPhosphorylationProtein Kinase InhibitorsReceptor, ErbB-2TOR Serine-Threonine KinasesTumor Suppressor ProteinsConceptsHER2-positive breast cancerCDK4/6 inhibitorsBreast cancerEGFR/HER2Patient-derived xenograft tumorsTransgenic mouse modelInhibition of CDK4/6Tumor recurrenceXenograft tumorsMouse modelPotent suppressionTransgenic modelClinical specimensTherapeutic resistanceDual inhibitionMediate resistanceHER2CancerTSC2 phosphorylationG1 arrestCellular senescenceTherapyRb phosphorylationTumorsCDK4/6