A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC

A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

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.

Inclusion Criteria:

• 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).
• No prior systemic treatment for advanced or metastatic TNBC.
• Measurable disease per RECIST v1.1.
• ECOG performance status of 0 or 1.
• Adequate hematologic, hepatic, and renal function.
• Willingness to provide informed consent.

Exclusion Criteria:

• 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.
• Pregnancy or lactation.
• Other active malignancies requiring treatment within the past 5 years.
• History of severe hypersensitivity reactions to study drugs.