Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is the molecular subtype with the poorest prognosis among breast cancers, characterized by high rates of early recurrence, rapid distant metastasis, and short overall survival. Due to the lack of estrogen receptor, progesterone receptor, and HER2 expression, TNBC is insensitive to endocrine therapy and targeted therapy, making chemotherapy the mainstay of systemic treatment for a long time. However, conventional chemotherapy offers limited efficacy, and treatment options become scarce after the development of drug resistance. In recent years, immune checkpoint inhibitors have shown promising prospects in TNBC, particularly in PD-L1-positive patients who may benefit from immunotherapy combined with chemotherapy; nevertheless, a substantial proportion of patients still fail to achieve durable responses. In addition, PARP inhibitors have provided a new therapeutic option for TNBC patients harboring gBRCA mutations, and they exhibit potential synergistic effects with immunotherapy. Retlirafusp alfa (SHR-1701) is a domestically developed bifunctional fusion protein targeting PD-L1 and TGF-β, which can simultaneously block the PD-1/PD-L1 pathway and neutralize TGF-β in the tumor microenvironment, thereby enhancing anti-tumor immune responses. It has demonstrated promising efficacy and manageable safety in tumor types such as gastric cancer. Based on the above background, this study aims to explore the efficacy and safety of Retlirafusp alfa combined with chemotherapy or fluzoparib in early-stage and advanced TNBC, in order to provide novel therapeutic strategies for TNBC patients.