Phase II Study Comparing Camrelizumab Plus Docetaxel and Carboplatin Versus Docetaxel and Carboplatin Alone as Pre-Surgery Treatment for Triple-Negative Breast Cancer in Women Aged 18 to 70

What this Trial Is About

Triple-negative breast cancer TNBC is a subtype of breast cancer that lacks ER, PR, and Her-2 proteins, making up 15%-20% of all breast cancers. TNBC patients do not benefit from endocrine or HER-2-targeted therapies but respond to cytotoxic drug treatments. Despite improvements, TNBC still has the worst prognosis among breast cancer types. This research evaluates camrelizumab combined with a less toxic anthracycline-free TCb regimen to find safer and more effective neoadjuvant therapy for lymph node-positive TNBC patients. The study compares the safety and effectiveness of two chemotherapy regimens given before surgery one group receives six cycles of TCb docetaxel and carboplatin combined with camrelizumab, a PD-1 inhibitor, and the other group receives six cycles of TCb alone. Each cycle lasts 21 days, with docetaxel and carboplatin administered on the first day, and camrelizumab given on the third day for the experimental group. Participants are randomly assigned in a 21 ratio to either group. Participants will undergo assessments including pathological complete response rate within 24 weeks, and longer-term measures like event-free survival, disease-free survival, distant disease-free survival, and objective response rate after surgery. Safety is monitored by recording adverse events after each chemotherapy cycle. The study lasts up to 10 years with follow-up to evaluate long-term outcomes, and participants provide informed consent before enrollment.

Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer