In this phase III trial, adding carboplatin to standard epirubicin, cyclophosphamide, and taxane regimen improved disease-free, distant disease-free, and overall survival in patients with early-stage triple-negative breast cancer. The addition of carboplatin led to increased hematologic toxicity, particularly neutropenia and thrombocytopenia, without new safety signals.
Study
|
Randomized, open-label, multicenter, phase III trial [RJBC 1501; NCT02455141] |
| Early-stage triple-negative breast cancer (TNBC) with node-positive or node-negative (tumor size ≥1.0 cm) |
| Epirubicin+Cyclophosphamide followed by Taxanes (EC-T, n=391) vs EC-T+Carboplatin (EC-TCb, n=395)
|
Efficacy
|
3yr DFS: 89.8% vs. 93.1% (EC-T vs. EC-TCb) |
| DFS: HR 0.66 [0.44-0.97] (p=0.034) |
| DDFS: HR 0.61 [0.38-0.98] |
| OS: HR 0.39 [0.16-0.94]
|
Safety
|
Grade >=3 AE: Neutropenia (37.8% vs 47.0%), Thrombocytopenia (0% vs 4.5%) |
| Treatment discontinuations due to toxicity: 0.3% vs 2.3%
|
J Clin Oncol 2025;44:143-152
http://doi.org/10.1200/JCO-25-02412
Reviewed by Ulas D. Bayraktar, MD on Jan 21, 2026
