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.
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;
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.
Patients receiving first-line treatment for advanced triple-negative breast cancer
Cohort
Prospective
Sacituzumab Govitecan (SG)+Toripalimab
DrugSacituzumab govitecan (Trodelvy): 10mg/kg, administered by intravenous infusion on day 1 and day 8. Toripalimab: 240mg, administered by intravenous infusion on day 1.
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
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