Revisiting surrogacy of pathological complete response for long-term survival in triple-negative breast cancer.

ABSTRACT:

Background

Pathological complete response has been used as a primary endpoint in neoadjuvant trials in early stage triple-negative breast cancer, and the Food and Drug Administration accepted pathological complete response as a surrogate endpoint for long-term survival outcomes in high-risk early stage breast cancer for new drug approval. However, there is insufficient trial-level data to robustly support pathological complete response as a surrogate for long-term survival in triple-negative breast cancer.

Methods

A systematic literature review was performed to identify randomized clinical trials of neoadjuvant systemic therapy for patients with clinical stage I-III triple-negative breast cancer. Data of odds ratios (ORs) for pathological complete response and hazard ratios

SUBMITTER: Yoshino T 

PROVIDER: S-EPMC11932712 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature