Neoadjuvant Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed By Docetaxel In Triple-Negative, Early-Stage Breast Cancer (Neocart): Results From A Multicenter, Randomized Controlled, Open-Label, Phase Ii Trial.

Previous studies have shown that the addition of carboplatin to neoadjuvant chemotherapy improved the pathologic complete response (pCR) rate in patients suffering from triple-negative breast cancer (TNBC), and patients who obtained a pCR could achieve prolonged event-free survival (EFS) and overall survival (OS). However, no studies have assessed the effects of the combination of docetaxel and carboplatin without anthracycline with taxane- and anthracycline-based regimens. The NeoCART study was designed as a multicenter, randomized controlled, open-label, phase 2 trial to assess the efficacy and safety of docetaxel combined with carboplatin in untreated stage II-III TNBC. All eligible patients were randomly assigned, at a 1:1 ratio, to an experimental docetaxel plus carboplatin (DCb) for 6 cycles group (DCb group) or an epirubicin plus cyclophosphamide for 4 cycles followed by docetaxel for 4 cycles group (EC-D group). PCR (ypT0/is ypN0) was evaluated as the primary outcome. Between September 1, 2016, and December 31, 2019, 93 patients were randomly assigned, and 88 patients were evaluated for the primary endpoint (44 patients in each group). In the primary endpoint analysis, 27 patients in the DCb group (61.4%, 95% CI 47.0-75.8) and 17 patients in the EC-D group achieved a pCR (38.6%, 95% CI 24.3-53.0) (odds ratio 2.52, 95% CI 2.4-43.1; p noninferiority = 0.004). Noninferiority was met, and the DCb regimen was confirmed to be superior to the EC-D regimen (P = 0.044, superiority margin of 5%). At the end of the 37-month median follow-up period, OS and EFS rates were equivalent in both groups. This article is protected by copyright. All rights reserved.