2021
Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial
Winer EP, Lipatov O, Im SA, Goncalves A, Muñoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J, investigators K. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. The Lancet Oncology 2021, 22: 499-511. PMID: 33676601, DOI: 10.1016/s1470-2045(20)30754-3.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerCombined positive scoreMedian overall survivalPD-L1 combined positive scoreTreatment-related adverse eventsPhase 3 trialChemotherapy groupOverall survivalPembrolizumab groupBreast cancerAdverse eventsPrimary endpointMetastatic diseaseEastern Cooperative Oncology Group performance statusPD-L1 tumor statusCommon grade 3Durable antitumour activityInvestigator-choice chemotherapyPrevious systemic treatmentSerious adverse eventsThird-line treatmentSubpopulation of patientsTreatment of patientsSingle-drug chemotherapyGenomic 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 resistancePalbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study
Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. The Lancet Oncology 2021, 22: 212-222. PMID: 33460574, DOI: 10.1016/s1470-2045(20)30642-2.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalAdjuvant endocrine therapyDisease-free survivalInvasive disease-free survival eventsDisease-free survival eventsEndocrine therapySecond interim analysisBreast cancerInterim analysisAdverse eventsEastern Cooperative Oncology Group performance scoreSecond pre-planned interim analysisHER2-negative breast cancerEarly-stage breast cancerSurvival eventsIndependent data monitoring committeePre-planned interim analysisCommon grade 3Treatment-related deathsSerious adverse eventsProgression-free survivalEarly breast cancerMetastatic breast cancerInteractive response technologyGroup performance score
2019
Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer
Poorvu PD, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Collins LC, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Jakubowski DM, Russell C, Winer EP, Partridge AH. Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer. Journal Of Clinical Oncology 2019, 38: 725-733. PMID: 31809240, PMCID: PMC7048163, DOI: 10.1200/jco.19.01959.Peer-Reviewed Original ResearchConceptsNode-positive breast cancerDistant recurrence-free survivalRecurrence scoreBreast cancerBreast Cancer StudyN0 diseaseN1 diseaseYoung womenYoung Women's Breast Cancer StudyPositive/HER2-negative breast cancerHER2-negative breast cancerHuman epidermal growth factor receptorEarly distant recurrenceEarly-stage estrogenN0 breast cancerRS risk groupsNode-positive diseaseMinority of patientsRecurrence-free survivalYears of ageEpidermal growth factor receptorGrowth factor receptorDistant recurrenceAxillary nodesEligible womenAtezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cells
2015
Molecular Phenotype of Breast Cancer According to Time Since Last Pregnancy in a Large Cohort of Young Women
Collins LC, Gelber S, Marotti JD, White S, Ruddy K, Brachtel EF, Schapira L, Come SE, Borges VF, Schedin P, Warner E, Wensley T, Tamimi RM, Winer EP, Partridge AH. Molecular Phenotype of Breast Cancer According to Time Since Last Pregnancy in a Large Cohort of Young Women. The Oncologist 2015, 20: 713-718. PMID: 26025931, PMCID: PMC4492229, DOI: 10.1634/theoncologist.2014-0412.Peer-Reviewed Original ResearchConceptsBreast cancer molecular phenotypesBreast cancerYoung womenFamily historyPregnancy-associated breast cancerMolecular phenotypesTumor histologic gradeBreast cancer riskBreast cancer phenotypeLast pregnancyParous womenProspective cohortCentral reviewHistologic gradeLike subtypeMolecular subtypesLarge cohortCancer riskPregnancyClinical practiceStudy questionnaireBiomarker expressionCancerTumor phenotypeWomenLocal 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
2014
Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831
Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. Journal Of Clinical Oncology 2014, 32: 3744-3752. PMID: 25332249, PMCID: PMC4226805, DOI: 10.1200/jco.2014.55.5730.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorOverall survivalBreast cancerEpidermal growth factor receptorGrowth factor receptorNCCTG N9831NSABP BEarly-Stage Human Epidermal Growth Factor ReceptorHER2-positive operable breast cancerNational Surgical Adjuvant BreastLarge adjuvant trialsOperable breast cancerAddition of trastuzumabAnti-HER2 agentsFactor receptorSurvival end pointsBreast cancer resultsDFS ratesOverall DFSAdjuvant BreastAdjuvant chemotherapyAdjuvant trialsOS ratesMedian timePatient subgroups
2013
Breast cancer presentation and diagnostic delays in young women
Ruddy KJ, Gelber S, Tamimi RM, Schapira L, Come SE, Meyer ME, Winer EP, Partridge AH. Breast cancer presentation and diagnostic delays in young women. Cancer 2013, 120: 20-25. PMID: 24347383, DOI: 10.1002/cncr.28287.Peer-Reviewed Original ResearchConceptsCare delaysSymptoms of cancerBreast cancerFirst visitYoung womenMulticenter cohort studyMedical record reviewPatient's first visitBreast cancer presentationBreast abnormalitiesFirst signOwn breast cancerHealth care providersMost young womenPoor financial statusCancer presentationCohort studyDiagnostic delayRecord reviewTumor characteristicsPoor outcomeSystemic symptomsDisease stageEligible participantsExamination abnormalities
2012
The 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
2011
Pathologic features and molecular phenotype by patient age in a large cohort of young women with breast cancer
Collins LC, Marotti JD, Gelber S, Cole K, Ruddy K, Kereakoglow S, Brachtel EF, Schapira L, Come SE, Winer EP, Partridge AH. Pathologic features and molecular phenotype by patient age in a large cohort of young women with breast cancer. Breast Cancer Research And Treatment 2011, 131: 1061-1066. PMID: 22080245, DOI: 10.1007/s10549-011-1872-9.Peer-Reviewed Original ResearchConceptsBasal-like carcinomasBreast cancerPathologic featuresYoung womenPatient ageTumor stageMolecular phenotypesInvasive breast cancerLuminal B tumorsPoor prognostic featuresDifferent age groupsClinical characteristicsB tumorsReceptor statusPrognostic featuresCentral reviewMedical recordsTumor gradeHigh prevalenceLarge cohortGeneral populationAge groupsBiomarker expressionCancerHER2
2008
Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial
Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. Journal Of Clinical Oncology 2008, 26: 1231-1238. PMID: 18250349, PMCID: PMC4048960, DOI: 10.1200/jco.2007.13.5467.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFluorouracilHeartHeart FailureHumansPrognosisReceptor, ErbB-2Risk FactorsSurvival RateTamoxifenTrastuzumabVentricular Dysfunction, LeftConceptsLeft ventricular ejection fractionAdjuvant breast cancer trialsBreast cancer trialsCardiac eventsLVEF decreaseCumulative incidenceArm BCancer trialsHER2-positive operable breast cancerPotential cardiac risk factorsOlder ageTrastuzumab-containing armsCardiac risk factorsOperable breast cancerVentricular ejection fractionAntihypertensive medicationsTrastuzumab discontinuationWeekly paclitaxelCardiac medicationsEjection fractionAntihypertensive agentsCardiac dysfunctionCardiac safetyCardiac functionControl arm
2007
Long‐term psychosocial adjustment of older vs younger survivors of breast and endometrial cancer
Kornblith AB, Powell M, Regan MM, Bennett S, Krasner C, Moy B, Younger J, Goodman A, Berkowitz R, Winer E. Long‐term psychosocial adjustment of older vs younger survivors of breast and endometrial cancer. Psycho-Oncology 2007, 16: 895-903. PMID: 17245695, DOI: 10.1002/pon.1146.Peer-Reviewed Original ResearchConceptsPsychosocial adjustmentLong-term psychosocial adjustmentWorse adaptationBattery of measuresCancer survivorsFear of recurrenceOlder survivorsYoung survivorsYoung cancer survivorsCancer-related problemsEndometrial cancer survivorsBetter adjustmentDepression ScaleSexual problemsHospital AnxietyLong-term survivorsTreatment completionPhysical functioningOlder breastSurvivorsEndometrial cancerStudy entryAdjustmentMost differencesAnxiety
2006
Tumor Therapeutic Response and Vessel Tortuosity: Preliminary Report in Metastatic Breast Cancer
Bullitt E, Lin NU, Ewend MG, Zeng D, Winer EP, Carey LA, Smith JK. Tumor Therapeutic Response and Vessel Tortuosity: Preliminary Report in Metastatic Breast Cancer. Lecture Notes In Computer Science 2006, 9: 561-568. PMID: 17354817, PMCID: PMC2504703, DOI: 10.1007/11866763_69.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerMetastatic brain tumorsTumor therapeutic responseBrain tumor therapyCurrent non-invasive methodsNon-invasive methodTumor responseTherapeutic responseTumor activityBrain tumorsVessel tortuosityPreliminary reportTumor therapyCancerTreatmentMRAPreliminary studyReportPatientsStatistical analysisTherapyTumorsMonthsResponse
2005
Quality of life among patients with Stage II and III breast carcinoma randomized to receive high‐dose chemotherapy with autologous bone marrow support or intermediate‐dose chemotherapy
Peppercorn J, Herndon J, Kornblith AB, Peters W, Ahles T, Vredenburgh J, Schwartz G, Shpall E, Hurd DD, Holland J, Winer E, Group T. Quality of life among patients with Stage II and III breast carcinoma randomized to receive high‐dose chemotherapy with autologous bone marrow support or intermediate‐dose chemotherapy. Cancer 2005, 104: 1580-1589. PMID: 16118805, DOI: 10.1002/cncr.21363.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBone Marrow TransplantationBreast NeoplasmsCarmustineChemotherapy, AdjuvantCisplatinCombined Modality TherapyCyclophosphamideDose-Response Relationship, DrugFemaleHumansMiddle AgedNeoplasm StagingQuality of LifeSurvival RateTime FactorsTransplantation, AutologousConceptsQuality of lifeFunctional Living Index-CancerPositive lymph nodesHigh-dose chemotherapySymptom Distress ScaleBreast carcinomaHDC armLymph nodesQOL scoresAutologous bone marrow supportAutologous stem cell supportMcCorkle Symptom Distress ScaleMultiple positive lymph nodesAutologous bone marrow transplantationIntensive adjuvant therapyBone marrow supportHigh-dose cyclophosphamideStem cell supportTotal QOL scoreBone marrow transplantationAdjuvant chemotherapyAdjuvant settingAdjuvant therapyMarrow supportIndex cancer
2002
Adherence to Therapy With Oral Antineoplastic Agents
Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to Therapy With Oral Antineoplastic Agents. Journal Of The National Cancer Institute 2002, 94: 652-661. PMID: 11983753, DOI: 10.1093/jnci/94.9.652.Peer-Reviewed Original ResearchConceptsOral antineoplastic agentsAntineoplastic agentsOral antineoplastic therapyOral anticancer agentsAssessment of adherenceStudy of adherencePrediction of adherenceImplementation of interventionsChemotherapy recommendationsOral medicationsPrescribed regimensClinical outcomesPatient adherencePediatric populationAdherence ratesPoor adherenceAntineoplastic therapyAdherence issuesClinical trialsCancer preventionPhysician's officeAdherence behaviorAvailable evidenceAdherenceCertain populations