Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer

This study is a single center, non blinded, randomized phase II clinical trial. A total of 40 patients early-stage T3-4NanyM0 any TanyN+M0 TNBC, who meet the inclusion and exclusion criteria, are planned to be enrolled. Patients will receive neoadjuvant chemotherapy as 4 course ddAC (doxorubicin 60 mg/m² as an and cyclophosphamide 600 mg/m² on day 1 every 2 weeks) + paclitaxel 80 mg/m² + carboplatin AUC2 on day 1 every 1 weeks a total of 12 weeks with camrelizumab at a dose of 200 mg once every 2 weeks for a total of 16 weeks. Imaging assessments will be conducted every 4 weeks during the neoadjuvant treatment phase. After the neoadjuvant treatment is completed, surgery will be performed within 4 weeks of the last study drug administration. Whether to receive adjuvant treatment after surgery will be determined by the investigator. The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety. During the follow-up phase, survival follow-up will be conducted every 3 months (±28 days) in the first year and every 6 months (±28 days) thereafter, until disease progression, disease recurrence, or until 3 years after the last patient is enrolled (whichever occurs first).