First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
Status:
NOT_YET_RECRUITING
Trial end date:
2028-03-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn if the drug Sacituzumab govitecan (SG) reduces disease progression when used as a first-line treatment in adults with advanced triple-negative breast cancer (TNBC) who have not received prior treatments in the advanced setting. It will also look at whether the effectiveness of the drug differs between TNBC adults with homologous recombination deficiency (HRD) subtypes and those with non-HRD subtypes. The main questions this study aims to answer are:
* Will patients with advanced TNBC who haven't received prior treatment in the advanced setting respond better (i.e., slowed disease progression) when given SG as a first-line treatment?
* Does the overall response rate of SG differ between HRD vs non-HRD advanced TNBC patients without prior treatment in the advanced setting?
Participants will:
* Be given drug SG on days 1 and 8 of 21-day cycle(s)
* Will continue (repeat) 21-day cycles until disease progression or voluntary withdrawal
* Visit the clinic for treatments on days 1 and 8
* Have long-term follow-up every 12 weeks via phone or in-clinic