Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Launched by GILEAD SCIENCES · Nov 21, 2022
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The ASCENT-05 clinical trial is studying a new treatment approach for patients with triple negative breast cancer (TNBC) who still have cancer remaining after surgery and previous therapy. This trial is comparing an experimental treatment that combines sacituzumab govitecan-hziy (SG) with pembrolizumab to the standard treatment options, which may include pembrolizumab alone or pembrolizumab with another medication called capecitabine. The goal is to find out if this new combination is more effective and safe for patients.
To participate in this trial, patients must be over 18 years old and have residual invasive TNBC in the breast or lymph nodes after receiving surgery and pre-surgical treatment. They should have had their cancer surgically removed, recovered from that surgery, and undergone appropriate radiotherapy. Importantly, patients with more advanced stages of cancer or certain health conditions may not be eligible. Participants can expect to receive close monitoring and support throughout the study, contributing valuable information to help improve future treatments for TNBC.
Gender
ALL
Eligibility criteria
- 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 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.
About Gilead Sciences
Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Sacramento, California, United States
Lexington, Kentucky, United States
Rochester, Minnesota, United States
Charleston, South Carolina, United States
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Mannheim, , Germany
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Lafayette, Indiana, United States
Dublin, , Ireland
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Shirley, New York, United States
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Rocky Mount, North Carolina, United States
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Ypsilanti, Michigan, United States
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Puyallup, Washington, United States
Worms, , Germany
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Zaragoza, , Spain
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Patients applied
Trial Officials
Gilead Study Director
Study Director
Gilead Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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