CamRelief
Trial question
What is the role of addition of camrelizumab to neoadjuvant chemotherapy in patients with early or locally advanced triple-negative breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
441 female patients.
Inclusion criteria: patients aged 18-75 years with early or locally advanced triple-negative breast cancer.
Key exclusion criteria: bilateral breast cancer; ductal or pleomorphic lobular carcinoma in situ; autoimmune disease requiring treatment; primary immunodeficiency; ILD; serious infection in the past 4 weeks; clinically significant CVD.
Interventions
N=222 camrelizumab and chemotherapy (camrelizumab 200 mg combined with chemotherapy every 2 weeks).
N=219 placebo and chemotherapy (matching placebo combined with chemotherapy every 2 weeks).
Primary outcome
Pathological complete response
56.8%
44.7%
56.8 %
42.6 %
28.4 %
14.2 %
0.0 %
Camrelizumab and
chemotherapy
Placebo and
chemotherapy
Significant
increase ▲
NNT = 8
Significant increase in pathological complete response (56.8% vs. 44.7%; AD 12.2%, 95% CI 3.3 to 21.2).
Secondary outcomes
No significant difference in event-free survival rate at 18 months (86.6% vs. 83.6%; HR 0.8, 95% CI 0.46 to 1.42).
No significant difference in disease-free survival rate at 12 months (91.9% vs. 87.8%; HR 0.58, 95% CI 0.27 to 1.24).
No significant difference in radiological objective response (87.4% vs. 82.6%; AD 4.7%, 95% CI -1.8 to 11.1).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients aged 18-75 years with early or locally advanced triple-negative breast cancer, camrelizumab and chemotherapy were superior to placebo and chemotherapy with respect to pathological complete response.
Reference
Li Chen, Hui Li, Hao Zhang et al. Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial. JAMA. 2025 Feb 25;333(8):673-681.
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