Efficacy and safety of camrelizumab combined with docetaxel and carboplatin as neoadjuvant therapy for triple-negative breast cancer: The HELEN-Trio 011 randomized clinical trial.

1009 Background: The KEYNOTE-522 trial demonstrated that adding a PD-1 inhibitor to neoadjuvant chemotherapy significantly improves pathological complete response (pCR) rates, albeit with notable toxicity. The phase III Camrelief trial further confirmed that camrelizumab combined with sequential neoadjuvant chemotherapy significantly improved pCR compared with placebo in early-stage triple-negative breast cancer (TNBC). This study aimed to evaluate the efficacy and safety of camrelizumab plus neoadjuvant docetaxel and carboplatin in previously untreated stage II–III TNBC. Methods: This multicenter, randomized, open-label, phase III trial (ClinicalTrials.gov identifier: NCT05475678) enrolled eligible female patients aged 18-70 years with previously untreated stage II-III TNBC. Patients were randomized (2:1) to receive six 21-day cycles of docetaxel (75 mg/m²) and carboplatin (area under the curve=6) on day 1, with or without camrelizumab (200 mg intravenously on day 3). The primary endpoint was pCR (ypT0/Tis ypN0), assessed in the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of the trial treatment. Results: Between December 2022 and June 2025, 369 patients from fourteen hospitals in China were enrolled and randomized to the camrelizumab-chemotherapy group (n=245) or the chemotherapy-alone group (n=124), of whom 352 comprised the mITT population. The pCR rate was 57.5% (134 of 233) in the camrelizumab-chemotherapy group versus 45.4% (54 of 119) in the chemotherapy-alone group (absolute difference, 12.2 percentage points; 95% CI, 1.4-22.9; one-sided P= 0.014). In the prespecified exploratory subgroup (CPS ≥1), pCR rates were 69.8% (97/139; 95% CI, 62.2%-77.4%) with camrelizumab-chemotherapy and 51.9% (41/79; 95% CI, 40.9%- 62.94%) with chemotherapy-alone (absolute difference, 17.9%; 95% CI, 5.3%-30.5%; one-sided P = 0.004). In the PD-L1-negative subgroup (CPS <1), pCR rates were 37.8% (31/82; 95% CI, 27.4%-48.2%) and 28.1% (9/32; 95% CI, 12.5%-43.7%), respectively (absolute difference, 9.7%; 95% CI, -10.5%-29.9%; one-sided P = 0.165). Grade 3 or higher treatment-related adverse events occurred in 24.8% (58/233) of patients in the camrelizumab-chemotherapy group, and 21.8% (26/119) in the chemotherapy-alone group. No treatment related deaths were reported. Conclusions: The addition of camrelizumab to neoadjuvant docetaxel and carboplatin significantly improved pCR rates in patients with stage II–III TNBC with a manageable safety profile. This anthracycline-free regimen represents a promising neoadjuvant treatment option for early TNBC. Clinical trial information: NCT05475678 .