Status:
RECRUITING
Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
TNBC
Eligibility:
FEMALE
18-75 years
Brief 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 cance...
Detailed Description
1\. Research Objectives： The overall objective of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced tripl...
Eligibility Criteria
Inclusion
- Female breast cancer patients aged 18 to 75 years old;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1;
- Patients with histologically or cytologically confirmed advanced triple-negative breast cancer;
- Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion;
- Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab.
Exclusion
- Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;
- Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;
- Patients who have previously used or are currently using PD-(L)1 inhibitors and/or ADC drugs containing topoisomerase inhibitors, such as sacituzumab govitecan, Dato-DXd, etc., as well as topoisomerase inhibitors;
- Patients who are considered by the investigator to be unsuitable for participating in this study.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06991790
Start Date
May 1 2025
End Date
May 1 2028
Last Update
May 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Cancer Hospital
Beijing, China, 100142