Multicenter phase 3 trial of addition of camrelizumab to neoadjuvant anthracycline-free chemotherapy for stage II-III TNBC

Neoadjuvant chemoimmunotherapy has become the standard-of-care for stage II-III triple-negative breast cancer (TNBC), however anthracycline-containing regimens are associated with considerable toxicity. The phase 3 HELEN-Trio 011 trial, at 14 centers in China evaluated addition of camrelizumab to the anthracycline-free docetaxel-carboplatin neoadjuvant regimen for stage II-III TNBC. Eligible patients were aged 18-70 years with previously untreated disease. Patients were randomized 2:1 to receive 6 cycles of neoadjuvant docetaxel plus carboplatin with (n=233) or without (n=119) camrelizumab 200 mg. The primary endpoint was pathological complete response (pCR). The pCR rate was 57.5% in the camrelizumab-chemotherapy group and 45.4% in the chemotherapy-alone group (p=0.014). Grade 3-4 treatment-related adverse events occurred in 24.9% of patients in the camrelizumab-chemotherapy group and 21.8% of patients in the chemotherapy-alone group. No treatment-related deaths were reported. The authors conclude that addition of camrelizumab to neoadjuvant docetaxel-carboplatin significantly increased the pCR rate in patients with stage II-III TNBC, with a manageable safety profile.