To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.
Age ≥18 years, female;
Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage <1%), PR-negative (IHC PR-positive percentage <1%), and HER2-negative (IHC -/+ or IHC ++ but FISH/CISH -);
At least one measurable lesion per RECIST version 1.1 criteria;
Life expectancy ≥3 months;
Concurrently receiving anti-tumor therapy in another clinical trial;
Received other anti-tumor therapy within 4 weeks prior to the first dose of study drug;
Prior treatment with tumor immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 inhibitors, etc.) or TGF-β inhibitors;
Prior treatment with PARP inhibitors (except for patients who completed PARP inhibitor therapy for ovarian cancer ≥5 years ago with no recurrence or metastasis);