Actively Recruiting
Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration
Led by Peking University Cancer Hospital & Institute · Updated on 2025-05-28
51
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients aged 18 to 75 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1
- Histologically or cytologically confirmed advanced triple-negative breast cancer
- No prior systemic treatment for advanced triple-negative breast cancer
- At least one measurable lesion according to RECIST 1.1 criteria
- Decision to receive sacituzumab govitecan and toripalimab combination treatment
You will not qualify if you...
- Symptomatic brain metastases requiring emergency radiotherapy or surgical intervention
- Previous treatment with HER2-targeted therapy or Trop-2-targeted therapy
- Previous or current use of PD-(L)1 inhibitors or antibody-drug conjugates containing topoisomerase inhibitors such as sacituzumab govitecan or Dato-DXd
- Investigator's judgment deeming the patient unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
Research Team
G
Guohong Song, Doctor of Medicine (M.D.)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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