Multicenter randomized phase 2 trial of neoadjuvant chemotherapy combinations for early-stage triple-negative breast cancer

The phase 2 HELEN-001 trial, at six centers in China, randomized female patients aged 18-70 years with stage II-III triple-negative breast cancer to six 3-week neoadjuvant cycles of docetaxel plus cisplatine (TP) or docetaxel plus doxorubicin plus cyclophosphamide (TAC). The primary endpoint was pathological complete response (pCR). The pCR rate was significantly higher with TP than with TAC (51.9% versus 35.8%; p=0.028). After median follow-up of 40 months, event-free survival was 86.1% in the TP group and 80% in the TAC group (HR 0.639; p=0.196); among germline BRCA1/2 mutation carriers , EFS was 100% versus 53.8% (p=0.008). Grade 3 or higher adverse events occurred in 54% of patients in the TP group and 48% in the TAC group. The authors conclude that the TP regimen demonstrated significantly improved pCR rates with a manageable toxicity profile, suggesting potential benefit of taxane plus platinum regimens in patients with TNBC.