Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0
CONCLUSION: 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.PMID:34003702 | DOI:10.1200/JCO.20.03613
Source: Clinical Genitourinary Cancer - Category: Cancer & Oncology Authors: Sara M Tolaney Elizabeth Garrett-Mayer Julia White Victoria S Blinder Jared C Foster Laleh Amiri-Kordestani E Shelley Hwang Judith M Bliss Eileen Rakovitch Jane Perlmutter Patricia A Spears Elizabeth Frank Nadine M Tung Anthony D Elias David Cameron Neeli Source Type: research