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

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.

Eligibility

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.

Conditions3

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