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NCT05633654 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Triple Negative Breast Cancer, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,514
- Enrollment target
- 20
- Study locations
NCT05633654 is a Phase 3 study of Triple Negative Breast Cancer that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 1,514 participants, above the 234-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (547% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT05633654, a Phase 3 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,514 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,514 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (547% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
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.
NCT05633654 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT05633654?
The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Sacituzumab govitecan-hziy (SG) (DRUG).
Who is sponsoring clinical trial NCT05633654?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.