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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: Recruiting Phase 3 study of Triple Negative Breast Cancer, sponsored by Gilead Sciences.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.

Conditions Studied

Triple Negative Breast Cancer

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

FieldValue
Enrollment Target 1,514 participants
Start Date 2022-12-12
Est. Completion 2031-08
Phase Phase 3
Gilead Sciences

504 total trials

What NCT05633654 shows while recruiting

NCT05633654 is an interventional study that assigns participants to a tested intervention. Its 1,514 participants enrollment target places it among the larger protocols in the corpus, above the 234-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (547% higher).

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 names 20 study sites across 5 states, led by 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

Similar trials for Triple Negative Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05633654's enrollment target sits among peer trials

1,514 5th of 118 higher than 114 of 118 other Triple Negative Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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More recruiting context for NCT05633654

Source: ClinicalTrials.gov NCT05633654, the US trial registry maintained by the National Library of Medicine. NCT05633654 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.