Neoadjuvant · Phase III multicentre open-label randomized; 369 enrolled, 352 mITT stage II–III TNBC. Docetaxel+carboplatin±camrelizumab. Primary endpoint pCR. · pCR 57.5% (134/233) vs 45.4% (54/119)

HELEN-Trio 011

Clinical question: Does adding camrelizumab to neoadjuvant docetaxel-carboplatin improve pCR in stage II–III triple-negative breast cancer?

pCR 57.5% (134/233) vs 45.4% (54/119); absolute difference 12.2 points (95% CI 1.4–22.9; P=0.014); NNT 9. · Registry:

Design, population and treatment

Phase III multicentre open-label randomized; 369 enrolled, 352 mITT stage II–III TNBC. Docetaxel+carboplatin±camrelizumab. Primary endpoint pCR.

Key efficacy outcome

57.5 · intervention

45.4

57.5 · comparator

NNT 9 for one additional pCR; approximate NNH 33 for grade 3–4 treatment-related AEs (3.1-point increase).

Grade 3–4 treatment-related AEs 24.9% vs 21.8%; no treatment-related deaths.

Safety and absolute effect

pCR rate (%)

https://pubmed.ncbi.nlm.nih.gov/42887596/

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1016/j.annonc.2026.10.102