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

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · May 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new combination treatment for advanced triple-negative breast cancer (TNBC), which is a type of breast cancer that doesn't respond to some common therapies. The study is looking at how well sacituzumab govitecan works when combined with toripalimab as a first treatment for patients with this condition. Researchers want to find out if this combination is safe and effective, and they will also explore specific markers in the body that might help predict how well the treatment will work.

To participate in this trial, women aged 18 to 75 with advanced TNBC who have not yet received treatment for their cancer may be eligible. Participants will have their health closely monitored to track how long their cancer remains stable and to check for any side effects. This is an exciting opportunity for those looking for new treatment options, and it could help improve how doctors understand and treat this challenging type of breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female breast cancer patients aged 18 to 75 years old;
• • 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1;
• • 3. Patients with histologically or cytologically confirmed advanced triple-negative breast cancer;
• • 4. Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer;
• • 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion;
• • 6. Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab.
• Exclusion Criteria:
• • 1. Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;
• • 2. Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;
• • 3. 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;
• • 4. Patients who are considered by the investigator to be unsuitable for participating in this study.