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.