2022
A randomized phase III, double-blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast cancer (A011502): The Aspirin after Breast Cancer (ABC) Trial
Chen W, Ballman K, Winer E, Openshaw T, Hahn O, Briccetti F, Irvin W, Pohlmann P, Carey L, Partridge A, Weiss A, McCall L, Matyka C, Carvan M, Holmes M. A randomized phase III, double-blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast cancer (A011502): The Aspirin after Breast Cancer (ABC) Trial. Journal Of Clinical Oncology 2022, 40: 360922-360922. DOI: 10.1200/jco.2022.40.36_suppl.360922.Peer-Reviewed Original ResearchInvasive disease-free survivalHER2-negative breast cancerStratified hazard ratioDisease-free survivalHazard ratioBreast cancerIDFS eventsAspirin usersCardiovascular diseaseGrade 3/4 adverse eventsAspirin/non-steroidal anti-inflammatory drugsNon-steroidal anti-inflammatory drugsAdjuvant aspirin therapyRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDouble-blinded fashionBreast cancer survivorsBody mass indexBreast cancer trialsBreast cancer survivalBreast cancer recurrenceMultiple epidemiologic studiesAnti-inflammatory drugsAnti-tumor effects
2021
Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0
Tolaney SM, Garrett-Mayer E, White J, Blinder VS, Foster JC, Amiri-Kordestani L, Hwang ES, Bliss JM, Rakovitch E, Perlmutter J, Spears PA, Frank E, Tung NM, Elias AD, Cameron D, Denduluri N, Best AF, DiLeo A, Baizer L, Butler LP, Schwartz E, Winer EP, Korde LA. Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0. Journal Of Clinical Oncology 2021, 39: 2720-2731. PMID: 34003702, PMCID: PMC10166345, DOI: 10.1200/jco.20.03613.Peer-Reviewed Original ResearchConceptsEfficacy end pointPrimary end pointBreast cancer clinical trialsPrimary cancerCancer clinical trialsEnd pointStandardized definitionsRecurrence rateClinical trialsInvasive disease-free survival eventsTherapy trialsBreast cancer-free survivalDisease-free survival eventsNon-breast cancer deathPrimary efficacy end pointClinical trial end pointsPhase III breast cancer trialsCancer-free survivalSecond primary cancerTrial end pointsAdditional end pointsBreast cancer trialsLow-risk populationPatient-reported outcomesSurvival end points
2019
The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial
Barroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Annals Of Oncology 2019, 30: 575-581. PMID: 30753274, PMCID: PMC8033534, DOI: 10.1093/annonc/mdz047.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiomarkers, TumorBreastBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedPaclitaxelReceptor, ErbB-2TrastuzumabTumor BurdenTumor MicroenvironmentConceptsHER2-positive breast cancerSmall HER2-positive breast cancersImmune gene signaturesBreast cancerImmune profileAPT trialPD-L1Immune markersImmune microenvironmentSmall HER2-positive tumorsStromal PD-L1 expressionNode-negative breast cancerCell signatureGene signatureHuman epidermal growth factor receptorStromal PD-L1PD-L1 expressionHistological grade 2Luminal B tumorsB cell signaturesBreast cancer trialsHER2-positive tumorsImmune cell signaturesBasal-like tumorsHistological grade 1
2016
Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527
Freedman RA, Foster JC, Seisler DK, Lafky JM, Muss HB, Cohen HJ, Mandelblatt J, Winer EP, Hudis CA, Partridge AH, Carey LA, Cirrincione C, Moreno-Aspitia A, Kimmick G, Jatoi A, Hurria A. Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal Of Clinical Oncology 2016, 35: 421-431. PMID: 27992272, PMCID: PMC5455700, DOI: 10.1200/jco.2016.69.4182.Peer-Reviewed Original ResearchConceptsOlder patientsMetastatic trialsAdjuvant trialsBreast cancerHormone receptor-negative tumorsBreast cancer treatment trialConclusion Older patientsSystemic therapy trialsReceptor-negative tumorsBreast cancer trialsCancer treatment trialsYears of ageAccrual challengesNeoadjuvant trialsAdjuvant studiesPatient ageTherapy cessationLymph nodesTherapeutic trialsTreatment cessationTumor sizeDisease characteristicsPatient populationTreatment trialsCancer trials
2013
Differences in psychosocial factors among diverse women enrolled in a phase III cooperative group metastatic breast cancer trial (CALGB 40502/Alliance).
Polite B, Allred J, Rugo H, Cipriano T, Cirrincione C, Gehlert S, Paskett E, Hudis C, Winer E. Differences in psychosocial factors among diverse women enrolled in a phase III cooperative group metastatic breast cancer trial (CALGB 40502/Alliance). Journal Of Clinical Oncology 2013, 31: 9581-9581. DOI: 10.1200/jco.2013.31.15_suppl.9581.Peer-Reviewed Original ResearchMetastatic breast cancer trialsBreast cancer trialsCancer trialsRace/ethnicitySocial supportBreast cancer patientsLower overall survivalLow social supportAfrican American womenSocio-demographic factorsOverall survivalHispanic patientsCancer patientsHigh comorbiditySelf-identified race/ethnicityPsychosocial factorsSelf-administered surveyPatientsLow levelsMarital statusEthnic differencesSurvivalTrialsComorbiditiesAmerican women
2009
Assays of circulating tumor cells and outcome in the triple-negative breast cancer trial TBCRC001.
Rugo H, Carey L, Mayer E, Marcom P, Liu M, Ma C, Storniolo A, Forero A, Esteva F, Wolff A, Hobday T, Ferraro M, Davidson N, Winer E, Moore D, Scott J, Park J. Assays of circulating tumor cells and outcome in the triple-negative breast cancer trial TBCRC001. Cancer Research 2009, 69: 6048. DOI: 10.1158/0008-5472.sabcs-6048.Peer-Reviewed Original ResearchBasal-like breast cancerArm 1Study treatmentCTC levelsTumor cellsPhase II studyPhase II trialTime pointsBreast cancer trialsMarkers of activityRank correlation coefficientCc bloodMetastatic BrCaShorter TSTPrimary endpointII studyII trialObjective responseFirst infusionCancer trialsEfficacy dataArm 2Breast cancerCTC measurementCTC enumeration
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