Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP.
Jennifer K LittonMeredith M ReganLajos PusztaiHope S RugoSara M TolaneyElizabeth Garrett-MayerLaleh Amiri-KordestaniReva K BashoAna F BestJean-Francois BoileauCarsten DenkertJared C FosterNadia HarbeckHeather A JaceneTari A KingGinny MasonCiara Catherine O'SullivanTatiana M ProwellAndrea L RichardsonKarla A SepulvedaMary Lou SmithJudy A TjoeGulisa TurashviliWendy A WoodwardLynn Pearson ButlerElena I SchwartzLarissa A KordePublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2023)
End points in addition to pCR should be selected on the basis of clinical and biologic aspects of the tumor and the therapeutic agent investigated. Consistent prespecified definitions and interventions are paramount for clinically meaningful trial results and cross-trial comparison.