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First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Dec 2025 to Jan 20, 2026 · Eligibility criteria expanded, about 33 words · Secondary endpoints: details revised at 1 of 4 entries · 2 more Show 5 more changesShow less
    • Start date changed from estimate of Dec 2025 to Jan 20, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised
    • Publications: details revised at 4 of 4 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07299409
Lead Sponsor Nathalie Levasseur
Collaborators: British Columbia Cancer Agency
Conditions Advanced Triple Negative Breast Cancer, Breast Cancer Metastatic, Breast Cancer
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov