Adjuvant Epirubicin Plus Cyclophosphamide Followed by Taxanes With or Without Carboplatin in Early-Stage Triple-Negative Breast Cancer (RJBC 1501): A Randomized Phase III Trial.

ABSTRACT:

Purpose

To evaluate the efficacy and safety of adjuvant epirubicin plus cyclophosphamide followed by taxanes (EC-T) versus EC-T plus carboplatin (EC-TCb) in patients with early-stage triple-negative breast cancer (TNBC).

Patients and methods

In this phase III trial, patients with TNBC with node-positive or node-negative (tumor size ≥1.0 cm) disease who received definitive surgery, were stratified by lymph node status and randomly assigned in a 1:1 ratio to receive four cycles of EC followed by four cycles T with or without carboplatin adjuvant chemotherapy. The primary end point was disease-free survival (DFS). Secondary end points included distant DFS (DDFS), overall survival (OS), and safety. This study had 80% power to detect a DFS hazard ratio (HR) of 0.64, with a two-si

SUBMITTER: Chen X 

PROVIDER: S-EPMC12794722 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature