This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive.
Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.
The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.
Female patients aged ≥18 years.
Histologically or cytologically confirmed triple-negative breast cancer (TNBC).
Unresectable locally advanced or metastatic disease.
PD-L1 positive (CPS ≥1 as assessed by central laboratory).
Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
Known active central nervous system metastases.
Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.
Active infection requiring systemic therapy.
Parallel
Sacituzumab Govitecan (SG)
DrugSacituzumab govitecan will be administered at 10 mg/kg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Toripalimab
DrugToripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Nab-paclitaxel
DrugNab-paclitaxel will be administered at 125 mg/m² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by investigators based on RECIST version 1.1 criteria.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. The event will be recorded regardless of cause and assessed continuously until the end of study follow-up.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR), confirmed at least 4 weeks after the initial response, as assessed by investigators according to RECIST version 1.1 criteria.
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurs first, as assessed by investigators according to RECIST version 1.1 criteria.
Time to Response (TTR)
Time to Response (TTR) is defined as the time from randomization to the first documentation of complete response (CR) or partial response (PR), as assessed by investigators according to RECIST version 1.1 criteria.
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