Annals of oncology : official journal of the European Society for Medical Oncology
October 16, 2026 · via Europe PMC
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.
Jiao D, Sun X, Qiao J, +36 more, Liu Z
AI summary — for doctors, generated from the abstract only
Adding camrelizumab to anthracycline-free docetaxel plus carboplatin raised the pathological complete response rate in stage II-III triple-negative breast cancer, with manageable safety.
What was studied
Multicenter, open-label, phase 3 randomized trial at 14 Chinese hospitals (2022-2025) giving 6 cycles of neoadjuvant docetaxel-carboplatin with or without camrelizumab, randomized 2:1; primary endpoint was pCR (ypT0/Tis ypN0) in the modified ITT population of 352 of 369 enrolled.
Key findings
- pCR was 57.5% (134/233) with camrelizumab versus 45.4% (54/119) with chemotherapy alone, 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 were 24.9% (58/233) versus 21.8% (26/119)
- No treatment-related deaths were reported
Clinical relevance
Offers a possible anthracycline-free chemoimmunotherapy option, though the authors note it must be compared with current standard regimens.
Who should care
Limitations
Open-label, pCR is a surrogate, no survival data in the abstract, and the one-sided P value with a lower CI bound of 1.4 points suggests a modest margin of evidence.
Higher pCR with acceptable toxicity, but long-term benefit and head-to-head comparison are unproven.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
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/m) 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 .
DOI
10.1016/j.annonc.2026.10.102
PMID
42887596
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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