Efficacy and safety of camrelizumab plus docetaxel and carboplatin as neoadjuvant therapy for stage II-III triple-negative breast cancer: the HELEN-Trio 011 randomized clinical trial.

BACKGROUND

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. We evaluated camrelizumab combined with an anthracycline-free docetaxel-carboplatin regimen in this setting.

PATIENTS AND

METHODS

We performed a multicenter, randomized, open-label, phase 3 trial at 14 hospitals in China between December 2022 and June 2025. Eligible patients were women aged 18-70 years with previously untreated, stage II-III TNBC. Patients were randomized 2:1 to receive 6 cycles of neoadjuvant docetaxel (75 mg/m2) plus carboplatin (area under the curve [AUC]=6) on day 1, with or without camrelizumab (200 mg intravenously on day 3). The primary endpoint was pathological complete response (pCR), defined as ypT0/Tis ypN0, evaluated in the modified intention-to-treat (mITT) population (all patients who received at least one dose of study treatment).

RESULTS

A total of 369 patients were enrolled, and 352 comprised the mITT population for efficacy analysis. The pCR rate was 57.5% (134/233) in the camrelizumab-chemotherapy group and 45.4% (54/119) in the chemotherapy-alone group, corresponding to an absolute difference of 12.2% (95% CI, 1.4 to 22.9; one-sided P=0.014). Grade 3-4 treatment-related adverse events occurred in 24.9% (58/233) in the camrelizumab-chemotherapy group and 21.8% (26/119) in the chemotherapy-alone group. No treatment-related deaths were reported.

CONCLUSION

The addition of camrelizumab to neoadjuvant docetaxel plus carboplatin significantly increased the pCR rate in patients with stage II-III TNBC, with a manageable safety profile. This regimen represents a promising anthracycline-free strategy that warrants comparison with current standard chemoimmunotherapy .