Multicenter phase 3 trial of adjuvant epirubicin plus cyclophosphamide followed by taxanes with or without carboplatin in early-stage TNBC

The phase 3 RJBC 1501 trial, at 19 centers in China, evaluated efficacy and safety of adjuvant epiribicin plus cyclophosphamide followed by taxanes (EC-T; n=391) versus EC-T plus carboplatin (EC-TCb; n=395) in patients with early-stage triple-negative breast cancer (TNBC) after definitive surgery. The primary endpoint was disease-free survival (DFS). With a median follow-up of 4.52 years (IQR 2.83-6.06), 62 and 41 DFS events were reported in the EC-T and the EC-TCb group, respectively. Adding carboplatin significantly improved DFS (HR 0.66; p=0.034), distant DFS (HR 0.61; p=0.040), and overall survival (HR 0.39; p=0.029). Grade 3 to 4 adverse events were more frequent in the EC-TCb group (49.9%) than in de EC-T group (38.7%), primarily driven by higher incidence of neutropenia and thrombocytopenia. The authors conclude that adding carboplatin to adjuvant EC-T significantly improved DFS, DDFS, and OS in patients with early-stage TNBC, with increased hematologic toxicity.