NCT07299409

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.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Nathalie Levasseur · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Triple Negative Breast Cancer
• Breast Cancer Metastatic
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan (SG)	Administer Sacituzumab Govitecan (SG) at 10 mg/kg as an intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. SG should not be administered as an IV push or bolus.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-08-01
• Completion: 2028-03-01
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

1 site across 1 country: Canada