2021
Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney 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.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxelGenomic Characterization of de novo Metastatic Breast Cancer
Garrido-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.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerPrimary tumorOverall survivalBreast cancerDe novo metastatic breast cancerNovo metastatic breast cancerDifferential therapeutic sensitivityBetter OSPoor OSShorter OSInitial diagnosisHigh TMBMetastatic tumorsDnMBCCurrent treatmentMutational burdenTreatment selectionMetastatic driversStage IMultiple comparison adjustmentTherapeutic sensitivityTumorsPatientsCancerIntrinsic resistance
2020
Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer
Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer. Breast Cancer Research And Treatment 2020, 186: 157-165. PMID: 33150547, DOI: 10.1007/s10549-020-05989-5.Peer-Reviewed Original ResearchConceptsRecurrence Score resultsNeoadjuvant chemotherapyPathological complete responseBreast cancerBreast Cancer StudyYoung womenEstrogen receptor-positive early breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyHER2-negative breast cancerScore resultsEarly breast cancerLogistic regression modelingAdjuvant chemotherapyNeoadjuvant therapyProspective cohortComplete responseMedian ageMultivariable analysisRecurrence scoreVs. 5Clinical careTumor specimensStage IPatientsTBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker
Mayer 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.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerHomologous recombination deficiencyPhase II studyPathologic responsePreoperative cisplatinII studyBreast cancerProspective phase II studyEffective predictive biomarkersInadequate clinical responsePreoperative chemotherapy regimenSingle-agent cisplatinHomologous recombination deficiency biomarkersGermline BRCA1/2Preoperative paclitaxelChemotherapy regimenClinical responseCisplatin chemotherapyPredictive biomarkersAlternative chemotherapyPreoperative trialInadequate responseHRD scoreStage IBaseline tissueTBCRC 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.Peer-Reviewed Original ResearchConceptsHER2-negative breast cancerTriple-negative breast cancerResidual cancer burden scoreBreast cancerDoxorubicin-cyclophosphamideRisk ratioStage IPathologic complete response rateHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Single-agent cisplatinComplete response ratePhase II studyPhase II trialGrowth factor receptor 2Positive breast cancerNegative breast cancerFactor receptor 2CT1-3II trialII studyNodal involvementPCR rateNegative diseasePathologic response
2019
TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker.
Mayer E, Abramson V, Jankowitz R, Falkson C, Marcom P, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Perou C, Richardson A, Tung N, Barry W, Tan-Wasielewski Z, Timms K, Hartman A, Wolff A, Winer E. TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker. Journal Of Clinical Oncology 2019, 37: 507-507. DOI: 10.1200/jco.2019.37.15_suppl.507.Peer-Reviewed Original ResearchPhase II studyII studyPreoperative chemotherapyHRD scoreRandomized phase II studyOne-sided type I errorCo-primary objectivesNew safety signalsSimilar response ratesHomologous recombination deficiency biomarkersPreoperative cisplatinTNBC cohortPathologic responseRCB 0Evaluable specimensPredictive biomarkersAlternative chemotherapySpecific chemotherapySafety signalsArm CCT armChemotherapyStage IResponse rateBaseline tissue
2016
Subtype-Dependent Relationship Between Young Age at Diagnosis and Breast Cancer Survival
Partridge AH, Hughes ME, Warner ET, Ottesen RA, Wong YN, Edge SB, Theriault RL, Blayney DW, Niland JC, Winer EP, Weeks JC, Tamimi RM. Subtype-Dependent Relationship Between Young Age at Diagnosis and Breast Cancer Survival. Journal Of Clinical Oncology 2016, 34: 3308-3314. PMID: 27480155, DOI: 10.1200/jco.2015.65.8013.Peer-Reviewed Original ResearchConceptsMultivariable Cox proportional hazards modelsCox proportional hazards modelBreast cancer deathsProportional hazards modelBreast cancerYears of ageYounger ageCancer deathHazards modelHuman epidermal growth factor receptor 2 subtypeStage INational Comprehensive Cancer Network centersBreast cancer-specific survivalEarly-stage breast cancerYoung womenCancer-specific survivalSurvival of womenEarly breast cancerLuminal B tumorsBreast cancer mortalityTriple-negative tumorsBreast cancer survivalLuminal breast cancerBreast cancer recurrenceBreast cancer subtypes
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 subgroupsChemotherapyCancerLocal Therapy Decision-Making and Contralateral Prophylactic Mastectomy in Young Women with Early-Stage Breast Cancer
Rosenberg SM, Sepucha K, Ruddy KJ, Tamimi RM, Gelber S, Meyer ME, Schapira L, Come SE, Borges VF, Golshan M, Winer EP, Partridge AH. Local Therapy Decision-Making and Contralateral Prophylactic Mastectomy in Young Women with Early-Stage Breast Cancer. Annals Of Surgical Oncology 2015, 22: 3809-3815. PMID: 25930247, PMCID: PMC4598267, DOI: 10.1245/s10434-015-4572-6.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAnxietyBody Mass IndexBreast NeoplasmsDecision MakingDirective CounselingFearFemaleGenes, BRCA1Genes, BRCA2Genetic TestingHumansLymphatic MetastasisMastectomy, SegmentalMutationNeoplasm StagingParityPatient ParticipationProphylactic Surgical ProceduresReceptor, ErbB-2RecurrenceTumor BurdenYoung AdultConceptsBreast-conserving surgeryContralateral prophylactic mastectomyEarly-stage breast cancerUnilateral mastectomyBreast cancerYoung womenProphylactic mastectomyUnilateral stage ILarger tumor sizeOngoing cohort studyGood psychosocial supportResultsMedian ageClinical characteristicsCohort studyHER2 positivityNodal involvementLocal therapyLower BMITumor sizeBRCA mutationsPatient-driven decisionSurgical decisionMethodsAs partMultinomial logistic regressionStage I
2013
Personalized medicine in breast cancer: tamoxifen, endoxifen, and CYP2D6 in clinical practice
Ruddy KJ, Desantis SD, Gelman RS, Wu AH, Punglia RS, Mayer EL, Tolaney SM, Winer EP, Partridge AH, Burstein HJ. Personalized medicine in breast cancer: tamoxifen, endoxifen, and CYP2D6 in clinical practice. Breast Cancer Research And Treatment 2013, 141: 421-427. PMID: 24062210, DOI: 10.1007/s10549-013-2700-1.Peer-Reviewed Original ResearchConceptsEndoxifen levelsEndocrine therapyBreast cancerCYP2D6 genotypeAdjuvant tamoxifenTamoxifen metabolismOptimal adjuvant endocrine therapyAlternative endocrine therapyBaseline whole bloodAdjuvant endocrine therapyMedical record reviewActual treatment decisionsPoor metabolizer genotypeCytochrome P450 2D6Record reviewClinical evidenceTreatment recommendationsTherapy recommendationsTreatment decisionsEstrogen receptorHormonal treatmentStage IClinical practicePatientsTamoxifenChoosing mastectomy over lumpectomy: Factors associated with surgical decisions in young women with breast cancer.
Rosenberg S, Sepucha K, Ruddy K, Tamimi R, Gelber S, Meyer M, Schapira L, Come S, Borges V, Winer E, Partridge A. Choosing mastectomy over lumpectomy: Factors associated with surgical decisions in young women with breast cancer. Journal Of Clinical Oncology 2013, 31: 6507-6507. DOI: 10.1200/jco.2013.31.15_suppl.6507.Peer-Reviewed Original ResearchBreast cancerYoung womenSurgical decisionStage IMulti-center cohort studyEstrogen receptor-positive tumorsReceptor-positive tumorsFinal multivariable modelFear of recurrenceDefinitive surgeryNodal involvementCohort studyMedian ageBilateral mastectomyER statusMultivariable analysisLower BMIPositive tumorsTumor sizeSurgical choiceOvarian cancerTumor gradeMultivariable modelMastectomyAge 40Racial/Ethnic Differences in Receipt of Timely Adjuvant Therapy for Older Women with Breast Cancer: Are Delays Influenced by the Hospitals Where Patients Obtain Surgical Care?
Freedman RA, He Y, Winer EP, Keating NL. Racial/Ethnic Differences in Receipt of Timely Adjuvant Therapy for Older Women with Breast Cancer: Are Delays Influenced by the Hospitals Where Patients Obtain Surgical Care? Health Services Research 2013, 48: 1669-1683. PMID: 23663229, PMCID: PMC3796107, DOI: 10.1111/1475-6773.12063.Peer-Reviewed Original ResearchConceptsTreatment delayBreast cancerTimely adjuvant therapyEnd Results (SEER) dataMultivariable logistic regressionEthnic differencesRace/ethnicityAdjuvant chemotherapyAdjuvant therapyMedicare claimsSurgical careHigher oddsOlder womenHispanic womenStage IHospitalLogistic regressionRacial disparitiesWomenPatientsBlack womenCancerCareResult dataImportant contributor
2012
Time to diagnosis and breast cancer stage by race/ethnicity
Warner ET, Tamimi RM, Hughes ME, Ottesen RA, Wong YN, Edge SB, Theriault RL, Blayney DW, Niland JC, Winer EP, Weeks JC, Partridge AH. Time to diagnosis and breast cancer stage by race/ethnicity. Breast Cancer Research And Treatment 2012, 136: 813-821. PMID: 23099438, PMCID: PMC3513497, DOI: 10.1007/s10549-012-2304-1.Peer-Reviewed Original ResearchConceptsRace/ethnicityLate-stage tumorsBreast cancerMedian timeNon-Hispanic Asian/Pacific Islander womenStage III/IV breast cancerAbnormal mammogramsNational Comprehensive Cancer Network centersAsian/Pacific Islander womenBreast cancer stageNon-Hispanic blacksPacific Islander womenNon-Hispanic whitesBreast cancer diagnosisAJCC criteriaHigher proportionSymptomatic womenCancer stageStage IStage IIIInitial signsThe Effect of Age on Delay in Diagnosis and Stage of Breast Cancer
Partridge AH, Hughes ME, Ottesen RA, Wong Y, Edge SB, Theriault RL, Blayney DW, Niland JC, Winer EP, Weeks JC, Tamimi RM. The Effect of Age on Delay in Diagnosis and Stage of Breast Cancer. The Oncologist 2012, 17: 775-782. PMID: 22554997, PMCID: PMC3380876, DOI: 10.1634/theoncologist.2011-0469.Peer-Reviewed Original ResearchConceptsHigher stage diseaseBreast cancerYoung womenStage diseaseNational Comprehensive Cancer Network centersInitial signsYounger ageHigher stageBreast cancer diagnosisAdvanced diseaseEffect of ageIndependent predictorsSymptomatic diseaseStage ICancerDiagnosisDiseaseSymptomsCancer diagnosisWomenOlder counterpartsAgeSimilar adjustmentSignsDays
2010
Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea
Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea. Journal Of Clinical Oncology 2010, 28: 2982-2988. PMID: 20479410, PMCID: PMC3664034, DOI: 10.1200/jco.2009.26.5900.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDiarrheaDose-Response Relationship, DrugDoxorubicinFeasibility StudiesFemaleFilgrastimFollow-Up StudiesGene AmplificationGranulocyte Colony-Stimulating FactorHumansImmunoenzyme TechniquesIn Situ Hybridization, FluorescenceLapatinibMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelPilot ProjectsPolyethylene GlycolsQuinazolinesReceptor, ErbB-2Recombinant ProteinsSurvival RateTrastuzumabTreatment OutcomeConceptsDose-dense ACDose-dense doxorubicinGrade 3 diarrheaBreast cancerDose reductionDose delay/reductionHER2-positive breast cancerHuman epidermal growth factor receptorAsymptomatic LVEF declineCardiac event ratePrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionDelays/reductionsEpidermal growth factor receptorExcessive diarrheaGrowth factor receptorLVEF declineWeekly paclitaxelEjection fractionHeart failureMedian agePatientsStage I
2009
Influence of birthplace on breast cancer diagnosis and treatment for Hispanic women
Kouri EM, He Y, Winer EP, Keating NL. Influence of birthplace on breast cancer diagnosis and treatment for Hispanic women. Breast Cancer Research And Treatment 2009, 121: 743-751. PMID: 19949856, DOI: 10.1007/s10549-009-0643-3.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsCase-Control StudiesEarly DiagnosisEmigrants and ImmigrantsFemaleHealth Services AccessibilityHealth Status DisparitiesHispanic or LatinoHumansLogistic ModelsMastectomy, SegmentalMiddle AgedMultivariate AnalysisRadiotherapy, AdjuvantResidence CharacteristicsRisk FactorsUnited StatesConceptsBreast cancerHispanic womenBreast cancer diagnosisRace/ethnicityPrimary therapyWhite womenStage I breast cancerNon-Hispanic white womenCancer diagnosisEarly-stage diseaseI breast cancerInvasive breast cancerAssociation of ethnicityForeign-born HispanicsInfluence of birthplaceTherapy differsTumor characteristicsSEER areasFirst diagnosisRates of stageAdjusted ratesMultinomial logistic regressionStage IAdvanced stageAppropriate interventionsClinicopathological features and sites of recurrence according to breast cancer subtype in the National Comprehensive Cancer Network (NCCN)
Lin N, Vanderplas A, Hughes M, Theriault R, Edge S, Wong Y, Blayney D, Niland J, Winer E, Weeks J. Clinicopathological features and sites of recurrence according to breast cancer subtype in the National Comprehensive Cancer Network (NCCN). Journal Of Clinical Oncology 2009, 27: 543-543. DOI: 10.1200/jco.2009.27.15_suppl.543.Peer-Reviewed Original ResearchNational Comprehensive Cancer NetworkSite of recurrenceBreast cancer subtypesClinicopathological featuresProgesterone receptorEstrogen receptorStage ICancer subtypesInvasive ductal histologyExtensive intraductal componentComprehensive Cancer NetworkPatterns of recurrenceFuture clinical trialsMultiple breast cancer subtypesStandard immunohistochemical markersDuctal histologyLymphovascular invasionNode positivityIntraductal componentHER2 statusTN tumorsClinical trialsBreast cancerSubtype distributionImmunohistochemical markers
2008
Trends in Racial and Age Disparities in Definitive Local Therapy of Early-Stage Breast Cancer
Freedman RA, He Y, Winer EP, Keating NL. Trends in Racial and Age Disparities in Definitive Local Therapy of Early-Stage Breast Cancer. Journal Of Clinical Oncology 2008, 27: 713-719. PMID: 19103731, DOI: 10.1200/jco.2008.17.9234.Peer-Reviewed Original ResearchConceptsDefinitive local therapyBreast-conserving surgeryEarly-stage breast cancerLocal therapyBreast cancerHispanic womenStage I/II breast cancerEnd Results registry dataAsian womenReceipt of radiationMultivariate logistic regressionBreast cancer therapyRace/ethnicityMastectomy ratesTherapy ratesBreast conservationAdjusted analysisRegistry dataWomen 61Stage ITherapyAdult womenLogistic regressionCancerStudy period
2007
Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study
Burstein H, Mayer E, Peppercorn J, Parker L, Hannagan K, Moy B, Younger J, Schapira L, Wulf G, Gelman R, Winer E. Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study. Journal Of Clinical Oncology 2007, 25: 594-594. DOI: 10.1200/jco.2007.25.18_suppl.594.Peer-Reviewed Original ResearchG-CSF supportNab-paclitaxelFebrile neutropeniaTreatment delayBreast cancerDoxorubicin/cyclophosphamideNab-paclitaxel therapyQuality of lifeDose-denseAdjuvant chemotherapyEligible patientsNeoadjuvant chemotherapyTaxane chemotherapyDose reductionFull cohortStage IPatientsNeutropeniaChemotherapyInstitutional studyPaclitaxelSignificant financial relationshipCycle 6CancerPrior studies
2006
Factors Related to Underuse of Surveillance Mammography Among Breast Cancer Survivors
Keating NL, Landrum MB, Guadagnoli E, Winer EP, Ayanian JZ. Factors Related to Underuse of Surveillance Mammography Among Breast Cancer Survivors. Journal Of Clinical Oncology 2006, 24: 85-94. PMID: 16382117, DOI: 10.1200/jco.2005.02.4174.Peer-Reviewed Original ResearchConceptsBreast cancer survivorsSurveillance mammographyCancer survivorsMonth 7Elderly breast cancer survivorsEnd Results-Medicare dataOlder breast cancer survivorsAnnual surveillance mammographyPrimary surgical therapyRepeated-measures logistic regressionLower mammography ratesQuarter of womenPopulation-based sampleService Medicare enrolleesBreast cancer diagnosisSurgical therapyAnnual mammographyGuideline recommendationsMedical oncologistsMultivariable analysisNonclinical factorsMammography ratesBreast cancerMammography useStage I