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

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of medicines to treat a specific type of advanced breast cancer called triple-negative breast cancer (TNBC) that tests positive for a protein called PD-L1. The study compares two treatment options: one group will receive sacituzumab govitecan plus toripalimab, and the other group will receive toripalimab plus nab-paclitaxel. Researchers want to see which treatment helps patients live longer without their cancer getting worse, and they will also look at how well the tumors respond to the treatments and what side effects happen.

Women who have not yet received treatment for advanced or hard-to-remove TNBC, are at least 18 years old, and have tumors that test positive for PD-L1 may be able to join this study. Participants will have regular check-ups and scans to monitor their tumor size and overall health. The trial is not yet recruiting, but it aims to find safer and more effective treatments for this challenging form of breast cancer. If you are considering joining, it’s important to discuss with your doctor whether this study fits your health situation.

Gender

FEMALE

Eligibility criteria

• 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 ≥10% 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.