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RECRUITING
NCT06991790

Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

The goal of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment in patients with advanced triple - negative breast cancer. The main questions it aims to answer are: 1. To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer. 2. To explore the biomarkers that can predict the efficacy of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer. Participants will: Have their progression - free survival (PFS) observed and evaluated. Have all adverse events and immune - related adverse events monitored to assess safety. Have their objective response rate measured as a secondary outcome. Have their survival period tracked as a secondary outcome. Have biomarkers associated with efficacy observed and explored as a secondary outcome.

Official title: A Prospective, Single-arm, Multicenter Phase II Clinical Study of Sacituzumab Govitecan in Combination With Toripalimab as First-line Treatment for Advanced Triple-negative Breast Cancer and an Exploratory Study of Biomarkers for Predicting Efficacy

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

51

Start Date

2025-05-01

Completion Date

2028-05-01

Last Updated

2025-05-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sacituzumab Govitecan (SG)+Toripalimab

Sacituzumab govitecan (Trodelvy): 10mg/kg, administered by intravenous infusion on day 1 and day 8. Toripalimab: 240mg, administered by intravenous infusion on day 1.

Locations (1)

Beijing Cancer Hospital

Beijing, China