2022
Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer
Waks 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.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMetastatic breast cancerAdverse eventsBreast cancerT-DM1Immune biomarkersTrastuzumab emtansineHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerGrade 3 adverse eventsMedian progression-free survivalTreatment-related adverse eventsHuman epidermal growth factor receptor 2Cell death ligand 1HER2-positive breast cancerEpidermal growth factor receptor 2Dose-finding cohortPhase 2 dosePhase Ib studyPhase Ib trialAnti-HER2 therapyDose-limiting toxicityGrowth factor receptor 2Immune checkpoint blockade
2019
Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study
Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O’Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J. Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 397-404. PMID: 30475950, DOI: 10.1093/annonc/mdy517.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerDisease control ratePD-L1Positive populationPembrolizumab monotherapyMetastatic diseaseControl rateBreast cancerTreatment-related adverse eventsEnd pointManageable safety profileObjective response ratePrimary end pointSecondary end pointsProgression-free survivalSubset of patientsDurable antitumor activityDuration of responseLine of treatmentEligible patientsMedian OSMedian PFSAdverse eventsMedian duration
2015
Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015
Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thürlimann B, Senn H, Members P, André F, Baselga J, Bergh J, Bonnefoi H, Burstein H, Cardoso F, Castiglione-Gertsch M, Coates A, Colleoni M, Curigliano G, Davidson N, Di Leo A, Ejlertsen B, Forbes J, Galimberti V, Gelber R, Gnant M, Goldhirsch A, Goodwin P, Harbeck N, Hayes D, Huober J, Hudis C, Ingle J, Jassem J, Jiang Z, Karlsson P, Morrow M, Orecchia R, Osborne C, Partridge A, de la Peña L, Piccart-Gebhart M, Pritchard K, Rutgers E, Sedlmayer F, Semiglazov V, Shao Z, Smith I, Thürlimann B, Toi M, Tutt A, Viale G, von Minckwitz G, Watanabe T, Whelan T, Winer E, Xu B. Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Annals Of Oncology 2015, 26: 1533-1546. PMID: 25939896, PMCID: PMC4511219, DOI: 10.1093/annonc/mdv221.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAxillaBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, Intraductal, NoninfiltratingCarcinoma, LobularChemotherapy, AdjuvantFemaleHumansLymph Node ExcisionMastectomyMastectomy, SegmentalNeoplasm StagingPlatinum CompoundsPractice Guidelines as TopicRadiotherapy, AdjuvantReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTamoxifenTaxoidsTrastuzumabConceptsEarly breast cancerLuminal diseaseBreast cancerSt Gallen International Breast Cancer ConferenceSt Gallen International Expert ConsensusNew breast cancer casesPanel recommendationsEndocrine-responsive diseaseHER2-positive diseaseOvarian function suppressionNode-positive diseaseBreast cancer deathsER-negative diseaseTreatment of patientsAnnals of OncologyNode-negative cancersPremature ovarian failureBreast cancer casesSubstantial new evidenceInternational expert consensusPremenopausal patientsSimplified regimenAdjuvant therapyAxillary dissectionPremenopausal women
2014
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano 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.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapy
2012
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
Krop 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.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsBridged-Ring CompoundsCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansImmunotoxinsLapatinibMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisQuinazolinesReceptor, ErbB-2TaxoidsTrastuzumabConceptsHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Metastatic breast cancerProgression-free survivalOverall response rateMedian progression-free survivalPhase II studyT-DM1II studyTrastuzumab emtansineBreast cancerResponse rateSingle-arm phase II studyEpidermal growth factor receptor 2Human epidermal growth factor receptorClinical benefit rateHER2-directed therapiesMost adverse eventsGrowth factor receptor 2Single-agent activityHER2-positive tumorsMultiple chemotherapy agentsEffective new treatmentsFactor receptor 2Epidermal growth factor receptor
2011
CMF revisited in the 21st century
Munzone E, Curigliano G, Burstein HJ, Winer EP, Goldhirsch A. CMF revisited in the 21st century. Annals Of Oncology 2011, 23: 305-311. PMID: 21715566, DOI: 10.1093/annonc/mdr309.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerClassical CMFOptimal chemotherapy backboneRecent retrospective dataUse of CMFTreatment of patientsTriple negative cellsPoly (ADP-ribose) polymerase (PARP) inhibitorsMechanism of actionAdjuvant CMFChemotherapy backboneAdjuvant treatmentRetrospective dataSpecific subgroupsPolymerase inhibitorsCancerTrue effectivenessPatientsCMFPlatinum compoundsDrugsTreatmentPast yearYears
2009
International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy
Cardoso F, Bedard PL, Winer EP, Pagani O, Senkus-Konefka E, Fallowfield LJ, Kyriakides S, Costa A, Cufer T, Albain KS, Force O. International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy. Journal Of The National Cancer Institute 2009, 101: 1174-1181. PMID: 19657108, PMCID: PMC2736293, DOI: 10.1093/jnci/djp235.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAnthracyclinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCapecitabineComorbidityCongresses as TopicCross-Over StudiesDeoxycytidineDrug Administration ScheduleEuropeEvidence-Based MedicineFemaleFluorouracilHumansInternational CooperationKarnofsky Performance StatusMenopausePatient SelectionPractice Guidelines as TopicQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexSocioeconomic FactorsTaxoidsVinblastineVinorelbineConceptsMetastatic breast cancerSequential single-agent chemotherapySingle-agent chemotherapyBreast cancerEarly-stage breast cancerEuropean Breast Cancer ConferenceSequential single agentsPatient-rated qualityRapid clinical progressionDisease-related factorsImpact of therapySequential monotherapyAdvanced diseaseSequential therapyVisceral metastasesCytotoxic chemotherapyTask ForceClinical progressionPredictive factorsTreatment optionsCancer ConferenceRapid symptomsSingle agentChemotherapyInternational guidelines
2008
Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer
Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Research And Treatment 2008, 115: 115-121. PMID: 18496750, DOI: 10.1007/s10549-008-0055-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCohort StudiesDeoxycytidineDisease ProgressionErbB ReceptorsErlotinib HydrochlorideFemaleFluorouracilHumansMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsQuinazolinesTaxoidsConceptsAdvanced breast cancerSafety of erlotinibBreast cancerCohort 1 patientsCohort 2 patientsResults One patientCommon adverse eventsPhase II studyAdvanced stage diseaseMetastatic breast cancerBreast cancer patientsPrimary endpointSecondary endpointsAdverse eventsII studyPartial responseMedian timePredictive factorsCancer patientsErlotinib treatmentCohort 2Cohort 1Design MulticenterOne patientDry skin
2007
Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions
Lin NU, Parker LM, Come SE, Burstein HJ, Haldoupis M, Ryabin N, Gelman R, Winer EP, Shulman LN. Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions. Investigational New Drugs 2007, 25: 369-375. PMID: 17345004, DOI: 10.1007/s10637-007-9034-y.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHypersensitivity reactionsEfficacy of CTBreast cancerPrior linesPatient populationGrade 3HER2-negative metastatic breast cancerSmall studyHER2-negative breast cancerTrue drug allergyPhase II studySecond-line chemotherapyPercent of womenNovel conjugatesAdjuvant settingConjugated paclitaxelEighteen womenIntravenous CTMetastatic treatmentPrior chemotherapyRoutine premedicationDrug allergyII studyObjective response
2002
Trastuzumab/chemotherapy combinations in metastatic breast cancer.
Ligibel JA, Winer EP. Trastuzumab/chemotherapy combinations in metastatic breast cancer. Seminars In Oncology 2002, 29: 38-43. PMID: 12138396, DOI: 10.1053/sonc.2002.34054.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-overexpressing metastatic breast cancerUse of trastuzumabBreast cancerRandomized phase III clinical trialsHER2-overexpressing breast cancerPhase III clinical trialsHER2/neu proteinAdvanced breast cancerFirst-line treatmentForm of chemotherapyHumanized monoclonal antibodyLonger survival durationHigh response rateNew chemotherapy drugsAdjuvant settingChemotherapy combinationsSurvival durationClinical trialsFurther trialsEfficacious treatmentPlatinum agentsSingle agentUS FoodDrug Administration
2001
New cytotoxic agents and schedules for advanced breast cancer
Burstein H, Bunnell C, Winer E. New cytotoxic agents and schedules for advanced breast cancer. Seminars In Oncology 2001, 28: 344-358. DOI: 10.1053/sonc.2001.26146.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsCisplatinClinical Trials as TopicDeoxycytidineDocetaxelDoxorubicinEnzyme InhibitorsFemaleFluorouracilGemcitabineHumansLiposomesPaclitaxelTaxoidsTopoisomerase I InhibitorsTrastuzumabVinblastineVinorelbineConceptsAdvanced breast cancerBreast cancerSide effectsUse of chemotherapyCombination of chemotherapyNovel biological agentsNew cytotoxic agentsTreatment of womenSuch biological therapiesCytotoxic chemotherapyBiological therapyVariety of agentsClinical activityAvailable agentsBetter survivalChemotherapyOral chemotherapeuticsCancerCytotoxic agentsWomenBiological agentsAgentsTherapyImportant studiesNew cytotoxic agents and schedules for advanced breast cancer
Burstein H, Bunnell C, Winer E. New cytotoxic agents and schedules for advanced breast cancer. Seminars In Oncology 2001, 28: 344-358. PMID: 11498829, DOI: 10.1016/s0093-7754(01)90129-0.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsCisplatinClinical Trials as TopicDeoxycytidineDocetaxelDoxorubicinEnzyme InhibitorsFemaleFluorouracilGemcitabineHumansLiposomesPaclitaxelTaxoidsTopoisomerase I InhibitorsTrastuzumabVinblastineVinorelbineConceptsAdvanced breast cancerBreast cancerSide effectsUse of chemotherapyCombination of chemotherapyNovel biological agentsNew cytotoxic agentsTreatment of womenSuch biological therapiesCytotoxic chemotherapyBiological therapyVariety of agentsClinical activityAvailable agentsBetter survivalChemotherapyOral chemotherapeuticsCancerCytotoxic agentsWomenBiological agentsAgentsTherapyImportant studies
2000
Letter to the Editor
Patridge A, Winer E. Letter to the Editor. Clinical Breast Cancer 2000, 1: 164-165. PMID: 11899655, DOI: 10.1016/s1526-8209(11)70117-3.Peer-Reviewed Original ResearchDocetaxel administered on a weekly basis for metastatic breast cancer.
Burstein H, Manola J, Younger J, Parker L, Bunnell C, Scheib R, Matulonis U, Garber J, Clarke K, Shulman L, Winer E. Docetaxel administered on a weekly basis for metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 1212-9. PMID: 10715290, DOI: 10.1200/jco.2000.18.6.1212.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerWeekly docetaxelBreast cancerPrior chemotherapyCumulative docetaxel doseGrade 4 toxicityGrade 3 toxicityPercent of patientsWeeks of therapySide effect profileSubgroup of patientsSimilar response ratesAdjuvant chemotherapyDocetaxel doseStable diseasePartial responseComplete responseTreat analysisTreatment breaksEffect profileFluid retentionPatient preferencesDisease progressionRepetitive dosingDose reduction