First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients. (NCT07299409)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (22 items).
Location: BC Cancer - Vancouver Center — Vancouver, British Columbia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Are within 4 weeks of participating in any other type of medical research judged by the Investigator to not be scientifically or medically compatible with this study.
- Tumour not accessible or not safe to perform biopsies.
- Has a known hypersensitivity to SG, irinotecan or its active metabolite SN-38.
- Has received prior antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Has a history of significant cardiovascular diseases, such as congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, serious cardiac arrhythmia, clinically significant electrocardiogram (ECG) findings or any other clinically significant cardiovascular condition, as determined by the Investigator.
- Has a history or evidence of any condition or laboratory abnormality that would place the participant at undue risk, as determined by the Investigator.
- Currently active Hepatitis B virus (HBV) or active Hepatitis C virus (HCV).
- For participants with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the participant may be eligible.
- Those who are HCV antibody positive with undetectable HCV viral load may be eligible.
- Has an active human immunodeficiency virus (HIV) infection (e.g., with detectable viral load). a. Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Has not had resolution of all acute toxic effects of prior anti-cancer therapy to CTCAE version 5.0 grade \<1 (except toxicities not considered a safety risk for the participant at Investigator's discretion, e.g. grade 2 peripheral neuropathy from prior chemotherapy).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- BC Cancer - Vancouver Center — Vancouver, British Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.