Surrogate endpoints for early-stage breast cancer: a review of the state of the art, controversies, and future prospects.

ABSTRACT: Drug approval for early-stage breast cancer (EBC) has been historically granted in the context of registration trials based on adequate outcomes such as disease-free survival and overall survival. Improvements in long-term outcomes have made it more difficult to demonstrate the clinical benefit of a new cancer drug in large, randomized, comparative clinical trials. Therefore, the use of surrogate endpoints rather than traditional measures allows for cancer drug trials to proceed with smaller sample sizes and shorter follow-up periods, which reduces drug development time. Among surrogate endpoints for breast cancer, the increase in pathological complete response (pCR) rates was considered appropriate for accelerated drug approval. The association between pCR and long-term outcomes was stron

SUBMITTER: Gion M 

PROVIDER: S-EPMC8640314 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature