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First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients. | Clinical Trials | Clareo Health

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

A Phase II Study of First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.

NCT07299409•Nathalie Levasseur

View on ClinicalTrials.gov

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

Detailed Description

This study is a non-randomized phase II single-arm trial of first-line sacituzumab govitecan (SG) in participants with advanced triple-negative breast cancer who have not received prior treatment in the advanced setting. It is designed to assess the overall response rate (ORR) of SG as well as compare the ORR of SG between homologous recombination-deficient (HRD) vs non-HRD in advanced TNBC patients, stratified by molecular subtypes using whole-genome and transcriptome analysis (WGTA). The 21-day cycle(s) treatment duration allows us to gather the necessary data to meet our primary and secondary objectives and exploratory endpoints. This study will be conducted in compliance with the protocol, the International Council of Harmonisation Good Clinical Practice guidelines, and every applicable regulatory requirement(s). This includes permitting study-related monitoring, audits, research ethics board review, and regulatory inspections, providing direct access to source data and documents.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet all the following criteria to be eligible for participation in this study:
•1. Willing and able to provide informed consent.
•2. 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.
•3. 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.
•4. For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry:
•i. Prior bilateral oophorectomy ii. Age \> 60 iii. Age \< 60 with \>12 months of spontaneous amenorrhea (not due to chemotherapy, tamoxifen, toremifene, or ovarian suppression) and laboratory confirmation of postmenopausal FSH and estradiol levels per local postmenopausal reference ranges iv. Ovarian suppression with gonadotropin-releasing hormone (GnRH) agonist (e.g., goserelin) initiated \>28 days before Cycle 1 Day 1
•14. Has a pre-existing condition with uncontrolled diarrhea, chronic inflammatory bowel disease (Ulcerative colitis, Crohn's Disease), or gastrointestinal perforation within 6-months prior to enrollment.
•15. Has active serious infection requiring antibiotics.
•16. Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may confound study interpretation or prevent completion of study procedures and follow-up examinations.
•17. Received a live vaccine within 30 days prior to enrollment.
+2 more criteria

Exclusion Criteria

•6. Histologically and/or cytologically confirmed diagnosis of estrogen-receptor negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
•7. 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.
•8. Not previously received systemic therapy in the advanced setting.
•9. Participants can have measurable or non-measurable disease by CT or MRI as per RECIST Version 1.1 criteria as evaluated locally. Tumour lesions situated in a previously irradiated area are considered measurable if unequivocal progression has been documented in such lesions since radiation. All radiology studies must be performed within 28-days of Day 1 Cycle 1.
•10. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
•11. Life expectancy \> 3 months.
•12. Acceptable bone marrow and organ function defined by the following laboratory values without transfusion or growth factor support within 2 weeks of treatment initiation:
•a. Absolute neutrophil count \> 1.0 x 109/L i. Platelets \> 100 x 109/L ii. Hemoglobin \> 90 g/dL iii. Potassium, sodium, calcium (corrected for serum albumin), and magnesium within normal limits.
•iv. INR \< 1.5 v. Serum creatinine \<1.5 x upper limit of normal (ULN) or calculated (Cockroft-Gault) or measured creatinine clearance ≥50 mL/min/1.73 m2 b. In absence of liver metastases, ALT and AST should be below \<3.0 x ULN. If the participant has liver metastases, ALT and AST should be \< 5.0 x ULN.
•c. In absence of liver metastases, total serum bilirubin \< ULN; If the participant has liver metastases, total bilirubin \< 3.0 x ULN with direct bilirubin \< 1.5 x ULN.
+19 more criteria

Locations (1)

BC Cancer - Vancouver Center

Vancouver, British Columbia, Canada

Key Dates

Start Date

December 1, 2025

Primary Completion Date

August 1, 2027

Completion Date

March 1, 2028

Last Updated

December 23, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Triple Negative Breast CancerBreast Cancer MetastaticBreast Cancer

Interventions

Sacituzumab Govitecan (SG)

DRUG

Contacts

Dr. Nathalie LeVasseur, MD

CONTACT

604-877-6000 nathalie.levasseur@bccancer.bc.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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