A Phase III, Multicenter, Randomized, Open-Label Parallel-Controlled Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With Adebrelimab (SHR-1316) Versus Investigator's Choice of Therapy in Subjects With Primary Triple Negative Breast Cancer Who Have Residual Invasive Disease Following Neoadjuvant Therapy
It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.
• Pathologically confirmed invasive triple negative breast cancer.
• Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.
• Previous neoadjuvant therapy must meet the requirements of the protocol.
• Has received radical surgery for breast cancer.
• ECOG PS 0\
• Adequate organ functions.
• Women of childbearing potential must be willing to use highly effective form of contraception.