摘要Objective: The objective of this open-label,randomized study was to compare dose-dense paclitaxel plus carboplatin (PCdd) with dose-dense epirubicin and cyclophosphamide followed by paclitaxel (ECdd-P) as an adjuvant chemotherapy for early triple-negative breast cancer (TNBC).Methods: We included Chinese patients with high recurrence risk TNBC who underwent primary breast cancer surgery.They were randomly assigned to receive PCdd[paclitaxel 150 mg/m2 on d 1 and carboplatin,the area under the curve,(AUC)=3 on d 2]or ECdd-P (epirubicin 80 mg/m2 divided in 2 d and cyclophosphamide 600 mg/m2 on d 1 for 4 cycles followed by paclitaxel 175 mg/m2 on d 1 for 4 cycles) every 2 weeks with granulocyte colony-stimulating factor (G-CSF) support.The primary endpoint was 3-year disease-free survival (DFS);the secondary endpoints were overall survival (OS) and safety.Results: The intent-to-treat population included 143 patients (70 in the PCdd arm and 73 in the ECdd-P arm).Compared with the ECdd-P arm,the PCdd arm had significantly higher 3-year DFS[93.9％ vs.79.1％;hazard ratio (HR)=0.310;95％ confidence interval (95％ CI),0.137-0.704;log-rank,P=0.005]and OS (98.5％ vs.92.9％;HR=0.142;95％ CI,0.060-0.825;log-rank,P=0.028).Worse neutropenia (grade 3/4) was found in the ECdd-P than the PCdd arm (47.9％ vs.21.4％,P=0.001).Conclusions: PCdd was superior to ECdd-P as an adjuvant chemotherapy for early TNBC with respect to improving the 3-year DFS and OS.PCdd also yielded lower hematological toxicity.Thus,PCdd might be a preferred regimen for early TNBC patients with a high recurrence risk.