Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT05633654 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Capecitabine
- DRUG Sacituzumab govitecan-hziy (SG)
Study Locations (20)
California
- Alta Bates Summit Medical Center — Berkeley
- Community Cancer Institute — Clovis
- PIH Health Whittier Hospital — Downey
- Compassionate Cancer Care Medical Group - Inc — Fountain Valley
- Los Angeles Cancer Network — Los Angeles
- USC Norris Comprehensive Cancer Center — Los Angeles
- Cedars-Sinai Cancer at Beverly Hills — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Emad Ibrahim, MD, INC — Redlands
- Sutter Institute for Medical Research — Sacramento
- UCSF Medical Center — San Francisco
- Sansum Clinic — Santa Barbara
- Stockton Hematology Oncology Medical Group — Stockton
Arizona
- Palo Verde Hematology Oncology — Glendale
- Mayo Clinic Hospital — Phoenix
- Arizona Oncology Associates — Prescott Valley
Alabama
- Alabama Oncology — Birmingham
- Clearview Cancer Institute — Huntsville
Colorado
- University of Colorado Cancer Center — Aurora
Connecticut
- Norwalk Hospital — Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,514 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2031-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05633654
The ClinicalTrials.gov registry entry for NCT05633654 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,514 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05633654 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05633654 about?
NCT05633654 is a clinical study titled "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)". The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine...
What is the current status of trial NCT05633654?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,514 participants. The study started on 2022-12-12. Estimated completion is 2031-08.
What conditions does trial NCT05633654 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05633654?
The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Sacituzumab govitecan-hziy (SG) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05633654?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05633654 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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