QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC.

Inclusion Criteria

• •1. Female aged ≥18 years;
• •2. TNBC invasive breast cancer confirmed by histology (specific definition: ER \<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative);
• •3. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
• •4. Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC.
• •5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
• •6. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
• •7. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
• •8. Eastern Cooperative Oncology Group (ECOG) score status 0-1 and life expectancy ≥3 months;
• •9. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
• •10. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.