Combination treatment for triple negative breast cancer after surgery

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 study evaluates the effectiveness and safety of sacituzumab govitecan-hziy combined with pembrolizumab compared to the treatment of physician's choice in patients with triple negative breast cancer who have residual invasive disease following surgery and neoadjuvant therapy. Participants must be over 18 years old and have undergone adequate surgical removal of their cancer. The study aims to determine if this new combination therapy can improve outcomes for patients who still have cancer after standard treatments.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:

  * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
* Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
* Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.
* Adequate organ function.

Key Exclusion Criteria:

* Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
* Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for \> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
* Evidence of recurrent disease following preoperative therapy and surgery.
* Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
* Individuals with germline breast cancer gene (BRCA) mutations.
* Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \< 50%
* Active serious infections requiring anti-microbial therapy.

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

Where it's running

• Alabama Oncology
  Birmingham, Alabama, United States Recruiting
• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• Palo Verde Hematology Oncology
  Glendale, Arizona, United States Recruiting
• Alta Bates Summit Medical Center
  Berkeley, California, United States Recruiting
• PIH Health Whittier Hospital
  Downey, California, United States Recruiting
• Cedars-Sinai Cancer at Beverly Hills
  Los Angeles, California, United States Recruiting

+328 more sites. See ClinicalTrials.gov for the full list.

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

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• 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

• 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

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  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

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  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Sacituzumab tirumotecan with or without pembrolizumab in ovarian clear cell cancer that has come back or spread

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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.