First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients. (NCT07299409) | Clinical Trial Compass
Not Yet RecruitingPhase 2
First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
Canada24 participantsStarted 2025-12
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide informed consent.
✓. Age \>18 years old at the time of informed consent and has signed informed consent before any trial related activities are conducted according to local guidelines.
✓. For participants of child-bearing potential (menstruation within \<2 years): negative serum pregnancy test within 14-days prior to enrollment and must be willing to use Health Canada-approved effective contraception methods (e.g., hormonal contraceptives, intrauterine device or system, tubal ligation, or double barrier method) starting 1 week prior to study treatment, throughout the study, and for 6 months following the last dose of SG.
✓. For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry:
✓. Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery and/or radiotherapy), including those who are PDL1 negative (combined positive score \[cps\] \<10), immuno-oncology therapy ineligible, or who had early-relapse after neoadjuvant therapy and not eligible for immuno-oncology in the first-line setting.
✓. Histologically and/or cytologically confirmed diagnosis of estrogen-receptor negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
✓
What they're measuring
1
Overall Response Rate (ORR) of SG in advanced TNBC
. HER2-negative breast cancer (based on most recently analyzed biopsy) defined as negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, SISH) test is required by local laboratory testing, as defined in the relevant American Society of Clinical Oncology / College of American Pathologists Guidelines.
✓. Not previously received systemic therapy in the advanced setting.
Exclusion criteria
✕. 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.