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NCT05382286 · ClinicalTrials.gov registry record · Phase 3

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

A Phase 3 study of Triple Negative Breast Cancer and PD-L1 Positive, sponsored by Gilead Sciences.

Active
Registry status
Phase 3
Development phase
443
Enrollment target
20
Study locations

NCT05382286: Active Phase 3 study of Triple Negative Breast Cancer and PD-L1 Positive, sponsored by Gilead Sciences.

NCT05382286 is a Phase 3 study of Triple Negative Breast Cancer and PD-L1 Positive that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 443 participants, above the 243-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (82% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05382286, a Phase 3 study of Triple Negative Breast Cancer and PD-L1 Positive, is active but no longer recruiting, sponsored by Gilead Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
443 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Primary Outcome

PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).

Conditions Studied

Triple Negative Breast Cancer PD-L1 Positive

Interventions

  • DRUG Pembrolizumab
  • DRUG Paclitaxel
  • DRUG Gemcitabine
  • DRUG Sacituzumab Govitecan-hziy
  • DRUG nab-Paclitaxel

Study Locations (20)

California

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 - Burbank
  • University of California Irvine Health Chao Family,1640 Newport Blvd - Costa Mesa
  • City of Hope - Duarte
  • University of California San Diego Moores Cancer - La Jolla
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 - Laguna Hills
  • Cancer and Blood Specialty Clinic - Los Alamitos
  • City of Hope,1601 Avocado Ave - Newport
  • University of California Irvine Health Chao Family - Orange
  • City of Hope,209 Fair Oaks Ave - Pasadena
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 - San Luis Obispo
  • Sansum Clinic - Santa Barbara

Arizona

  • Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd - Tucson
  • Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd. - Tucson
  • Arizona Oncology Associates, PC-Hope - Tucson
  • Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road - Tucson

Arkansas

  • Genesis Cancer and Blood Institute - Hot Springs
  • Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B. - Hot Springs
  • Saint Bernards Medical Center - Jonesboro
  • Saint Bernards Medical Center,4000 Linwood Drive - Paragould

Alaska

  • Alaska Oncology and Hematology - Anchorage

Trial Details

FieldValue
Enrollment Target 443 participants
Start Date 2022-07-25
Est. Completion 2027-02
Phase Phase 3
Gilead Sciences

504 total trials

What the registry record for NCT05382286 still lists

NCT05382286 is an interventional study that assigns participants to a tested intervention. The registered 443 participants enrollment target is mid-sized for trials with a published cap, above the 243-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (82% higher).

The record links to 2 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05382286 names 20 study sites across 4 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05382286 about?

NCT05382286 is a clinical study titled "Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer". The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-n...

What is the current status of trial NCT05382286?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 443 participants. The study started on 2022-07-25. Estimated completion is 2027-02.

What conditions does trial NCT05382286 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer, PD-L1 Positive.

What interventions are being tested in trial NCT05382286?

The interventions under investigation include: Pembrolizumab (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG), Sacituzumab Govitecan-hziy (DRUG), nab-Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT05382286?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05382286 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. 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 NCT05382286's enrollment target sits among peer trials

443 17th of 118 higher than 102 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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Related registry views

Source: ClinicalTrials.gov NCT05382286, the US trial registry maintained by the National Library of Medicine. NCT05382286 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.