Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0.
Sara M TolaneyElizabeth Garrett-MayerJulia R WhiteVictoria S BlinderJared C FosterLaleh Amiri-KordestaniE Shelley HwangJudith M BlissEileen RakovitchJane PerlmutterPatricia A SpearsElizabeth FrankNadine M TungAnthony D EliasDavid A CameronNeelima DenduluriAna F BestAndrea GombosLawrence BaizerLynn Pearson ButlerElena SchwartzEric P WinerLarissa A KordePublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
We recommend an additional end point, invasive breast cancer-free survival, which includes all invasive disease-free survival events except second nonbreast primary cancers. This end point should be considered for trials in which the toxicities of agents are well-known and where the risk of second primary cancer is small. Additionally, we provide end point recommendations for local therapy trials, low-risk populations, noninferiority trials, and trials incorporating patient-reported outcomes.