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
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
2007
Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations
Wray RJ, Stryker JE, Winer E, Demetri G, Emmons KM. Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations. Journal Of Cancer Education 2007, 22: 21. PMID: 17570804, DOI: 10.1007/bf03174370.Peer-Reviewed Original ResearchAssociation between pharmaceutical involvement and outcomes in breast cancer clinical trials
Peppercorn J, Blood E, Winer E, Partridge A. Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer 2007, 109: 1239-1246. PMID: 17326054, DOI: 10.1002/cncr.22528.Peer-Reviewed Original ResearchConceptsBreast cancer clinical trialsCancer clinical trialsPharmaceutical involvementClinical researchClinical trialsPharmaceutical industry involvementBreast cancer clinical researchSingle-arm studyDisease-specific outcomesClinical breast cancer researchCancer clinical researchBreast cancer researchEnglish-language medical journalsPharmaceutical industry fundingProvision of drugsMetastatic diseaseMedical therapyEligible studiesBreast cancerClinical studiesTrial designStudy designUnpublished studiesHealth fundingPharmaceutical industry support