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
In brief
Camrelizumab raises complete tumor response from 45% to 58% in breast cancer trial
In this randomized phase 3 trial of women with stage II-III triple-negative breast cancer, adding camrelizumab to docetaxel and carboplatin increased the rate of no cancer found in breast and lymph node tissue after treatment by about 12 percentage points. Severe treatment-related side effects were similar between groups, but the regimen still needs comparison with current standard chemoimmunotherapy.
- Journal
- Annals of oncology : official journal of the European Society for Medical Oncology (Q1)
- Published
- 16 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- D Jiao, X Sun, J Qiao, H Jia, X Liu, H Dai, et al.
- PMID
- 42887596
- DOI
- 10.1016/j.annonc.2026.10.102
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (paper of the day, 18 October 2026): Phase 3 neoadjuvant camrelizumab + docetaxel/carboplatin trial
- Picked for Surgical Oncology (top studies of the week, 18 October 2026): Neoadjuvant chemo‑immunotherapy trial informs surgical planning in TNBC
Abstract
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 .
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.