Testing a new dosing schedule of sacituzumab govitecan for advanced triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) administered at an alternative dose and schedule in patients with advanced triple-negative breast cancer (TNBC). The study consists of two phases: Phase 1 focuses on assessing the preliminary safety, tolerability, pharmacokinetics, and efficacy of SG, while Phase 2 will further investigate these aspects in a larger cohort. The primary objectives include measuring the objective response rate and progression-free survival among participants.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
* Histologically or cytologically locally confirmed TNBC.
* Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.
* Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
* Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) \< 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.
* Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.

During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.

After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.

* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate hematologic counts within 2 weeks prior to enrollment.
* Adequate hepatic and renal function.

Key Exclusion Criteria:

* Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
* Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.

Note: Other protocol defined Inclusion/Exclusion criteria will apply.

Where it's running

• Los Angeles Cancer Network (LACN) - Good Sam
  Los Angeles, California, United States Recruiting
• Winship Cancer Institute - Emory University
  Atlanta, Georgia, United States Recruiting
• The University of Kansas Hospital
  Westwood, Kansas, United States Recruiting
• Siteman Cancer Center
  St Louis, Missouri, United States Recruiting
• West Cancer Centre
  Germantown, Tennessee, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination treatment for triple-negative breast cancer after surgery

  This study is testing a new combination treatment for people with triple-negative breast cancer who didn't fully respond to earlier therapy after surgery to see if it helps them stay cancer-free longer.

  Recruiting at 299 sites Phase 3 Merck Sharp & Dohme LLC · Mobile, Alabama and 313 other locations · NCT06393374

• Combining Sacituzumab Govitecan and Zimberelimab with Stereotactic Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

  This study is testing if combining two treatments, Sacituzumab Govitecan and Zimberelimab, with targeted radiation can help adults with metastatic triple negative breast cancer that has spread to the brain feel better compared to just using Sacituzumab Govitecan alone.

  Recruiting Phase 1/2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT06238921

• Comparing two treatments for low-risk triple-negative breast cancer

  This study is testing whether adding pembrolizumab to sacituzumab govitecan can help people with low-risk triple-negative breast cancer do better after their initial treatment.

  Recruiting at 38 sites Phase 3 Women's Cancer Study Group GmbH · Baden-Baden, Baden-Wurttemberg and 42 other locations · NCT06081244

• Combination treatment for triple negative breast cancer after surgery

  This study is testing if a new combination of two cancer drugs can help adults with triple negative breast cancer who still have cancer after surgery feel better and live longer.

  Recruiting at 290 sites Phase 3 Gilead Sciences · Birmingham, Alabama and 377 other locations · NCT05633654

• Testing Sacituzumab Govitecan with or without Pembrolizumab for metastatic triple-negative breast cancer

  This study is testing whether a new cancer drug called Sacituzumab Govitecan, alone or with another drug called Pembrolizumab, can help people with metastatic triple-negative breast cancer that hasn't been treated before.

  Recruiting at 15 sites Phase 2 Dana-Farber Cancer Institute · Stamford, Connecticut and 14 other locations · NCT04468061

• Atezolizumab and sacituzumab govitecan to prevent recurrence in triple-negative breast cancer

  This trial tests whether combining sacituzumab govitecan with atezolizumab can prevent cancer from coming back in people with triple-negative breast cancer who have residual disease after pre-surgery chemotherapy and detectable circulating tumor DNA.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · San Francisco, California and 6 other locations · NCT04434040

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.