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
2016
Perils of the Pathologic Complete Response
Rose BS, Winer EP, Mamon HJ. Perils of the Pathologic Complete Response. Journal Of Clinical Oncology 2016, 34: 3959-3962. PMID: 27551115, DOI: 10.1200/jco.2016.68.1718.Peer-Reviewed Original Research
2009
Sharing Study Results With Trial Participants: Time for Action
Partridge AH, Winer EP. Sharing Study Results With Trial Participants: Time for Action. Journal Of Clinical Oncology 2009, 27: 838-839. PMID: 19164202, DOI: 10.1200/jco.2008.20.0865.Peer-Reviewed Original Research
2008
The impact of sharing results of a randomized breast cancer clinical trial with study participants
Partridge AH, Wolff AC, Marcom PK, Kaufman PA, Zhang L, Gelman R, Moore C, Lake D, Fleming GF, Rugo HS, Atkins J, Sampson E, Collyar D, Winer EP. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Research And Treatment 2008, 115: 123-129. PMID: 18543100, DOI: 10.1007/s10549-008-0057-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnxietyChemotherapy, AdjuvantClinical Trials, Phase III as TopicCommunicationData CollectionHumansMiddle AgedPatient Education as TopicPatient SatisfactionPerceptionRandomized Controlled Trials as TopicRecurrenceRegression AnalysisResearch DesignTrastuzumabConceptsCancer clinical trialsClinical trialsStudy participantsBreast cancer clinical trialsCooperative group trialsSubset of womenResults One hundredClinical trial participantsPercent of participantsRecurrent diseasePatients' perceptionsGroup trialsTrial participantsFavorable responsePsychosocial supportLogistic regressionOne hundredTrialsPatientsTrastuzumabStudy resultsParticipantsTreatmentPreliminary study resultsAnxiety
2005
Dose Density in Breast Cancer: A Simple Message?
Lin NU, Gelman R, Winer EP. Dose Density in Breast Cancer: A Simple Message? Journal Of The National Cancer Institute 2005, 97: 1712-1714. PMID: 16333021, DOI: 10.1093/jnci/dji438.Peer-Reviewed Original ResearchAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantClinical Trials, Phase III as TopicConfounding Factors, EpidemiologicCyclophosphamideDisease-Free SurvivalDose-Response Relationship, DrugEpirubicinFemaleFluorouracilHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignRisk FactorsSurvival AnalysisTreatment Outcome