2021
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
Krop 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.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalOverall populationTrastuzumab emtansineHigh-risk human epidermal growth factor receptorHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Early breast cancer treatmentHuman epidermal growth factor receptorAnthracycline-based chemotherapyCoprimary end pointsPrimary end pointDisease-free survivalSerious adverse eventsEarly breast cancerGlobal health statusGrowth factor receptor 2Treatment completion ratesStandard of careBreast cancer treatmentFactor receptor 2Epidermal growth factor receptorGrowth factor receptorEndocrine therapyAdverse events
2020
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.Peer-Reviewed Original ResearchHER2-positive early breast cancerInvasive disease-free survivalEarly breast cancerPatient-reported outcomesCo-primary endpointsStandard of careT-DM1ITT populationOverall survivalAnthracycline-based chemotherapyOpen-label studyDisease-free survivalPhase III studyWeeks of surgeryHigh-risk populationChemotherapy-associated toxicityAdjuvant taxanesConcurrent trastuzumabEndocrine therapySecondary endpointsAdjuvant radiotherapyAdjuvant therapyIII studyNodal statusMore patients
2016
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.
Goss P, Ingle J, Pritchard K, Robert N, 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.2016.34.18_suppl.lba1.Peer-Reviewed Original ResearchEarly-stage breast cancerYears of tamoxifenAromatase inhibitor therapyDisease-free survivalBreast cancerAI treatmentPostmenopausal womenInhibitor therapyHormone receptor-positive early breast cancerReceptor-positive early breast cancerTwo-sided log-rank testDisease-free survival eventsPositive early breast cancerPrior adjuvant chemotherapyPlacebo-controlled trialYear overall survivalContralateral breast cancerEarly breast cancerAnnual incidence rateStage breast cancerLog-rank testStandard of careBreast cancer recurrenceAdjuvant chemotherapyAdjuvant letrozole
2015
Tailoring adjuvant chemotherapy regimens for patients with triple negative breast cancer
Stover DG, Winer EP. Tailoring adjuvant chemotherapy regimens for patients with triple negative breast cancer. The Breast 2015, 24: s132-s135. PMID: 26255198, DOI: 10.1016/j.breast.2015.07.032.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerAdjuvant chemotherapyHigh-risk triple negative breast cancerLong-term outcome dataAnthracycline-taxane combinationsBRCA mutation carriersStandard of careNegative breast cancerPoor prognosis subtypeAdjuvant settingStandard regimensToxic regimensMetastatic settingCytotoxic chemotherapySystemic therapyImmune infiltratesTumor characteristicsMutation carriersOutcome dataWarrants further considerationStage ISpecific subgroupsChemotherapyCancer
2014
Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profile
2011
Can Axillary Node Dissection Be Omitted in a Subset of Patients with Low Local and Regional Failure Rates?
Barkley C, Burstein H, Smith B, Bellon J, Wong J, Gadd M, Taghian A, Winer E, Iglehart JD, Harris J, Golshan M. Can Axillary Node Dissection Be Omitted in a Subset of Patients with Low Local and Regional Failure Rates? The Breast Journal 2011, 18: 23-27. PMID: 22017599, DOI: 10.1111/j.1524-4741.2011.01178.x.Peer-Reviewed Original ResearchConceptsPositive sentinel lymph nodesSentinel lymph node biopsySentinel lymph nodesAxillary node dissectionCompletion axillary node dissectionLow-risk patient populationAdjuvant treatment patternMedian patient agePercent of patientsLymph node biopsyStandard of careNodal radiationNode dissectionMicrometastatic diseaseNode biopsyLymph nodesPatient ageTreatment patternsPatient populationBreast cancerClinical dataRadiation therapyPatientsDiseaseMacrometastasis
2008
Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease
Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease. Journal Of Clinical Oncology 2008, 26: 814-819. PMID: 18258991, DOI: 10.1200/jco.2007.15.3510.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsCongresses as TopicFemaleHumansMastectomy, SegmentalNational Cancer Institute (U.S.)Neoadjuvant TherapyNeoplasm, ResidualPatient Care TeamPatient SelectionPreoperative CareReceptor, ErbB-2Remission InductionUnited StatesConceptsOperable breast cancerPreoperative systemic therapyBreast conservation ratesSystemic therapyInvasive breast cancerBreast cancerTumor responsePreoperative therapyPathologic assessmentNational Cancer Institute StatePostoperative adjuvant systemic therapyInitial tumor responseAdjuvant systemic therapyPathologic complete responseSurrogate end pointsStandard of careMultimodality treatment programBreast cancer biologyAdjuvant settingOperable diseaseOverall survivalPreoperative chemotherapySystemic treatmentComplete responseLymph nodes