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NCT05382299 · ClinicalTrials.gov registry record · Phase 3
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice 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 Negative, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 623
- Enrollment target
- 20
- Study locations
NCT05382299 is a Phase 3 study of Triple Negative Breast Cancer and PD-L1 Negative that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 623 participants, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (159% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT05382299, a Phase 3 study of Triple Negative Breast Cancer and PD-L1 Negative, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 623 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) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Conditions Studied
Interventions
- DRUG Carboplatin
- 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 San Diego Moores Cancer - La Jolla
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 - Laguna Hills
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 - San Luis Obispo
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600 - Santa Monica
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304 - Santa Monica
- University of California Los Angeles - Jonsson Comprehensive Cancer Center - Santa Monica
- Torrance Memorial Physician Network - Cancer Care - Torrance
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100 - Westlake Village
Colorado
- Rocky Mountain Cancer Centers,1700 South Potomac Street - Aurora
- Rocky Mountain Cancer Centers - Boulder
- Rocky Mountain Cancer Centers,2312 N. Nevada Avenue - Colorado Springs
- Rocky Mountain Cancer Centers,6031 E. Woodman Rd. - Colorado Springs
- Rocky Mountain Cancer Centers,4700 E. Hale Parkway - Denver
- Rocky Mountain Cancer Centers,11750 West 2nd Place - Lakewood
- Rocky Mountain Cancer Centers,22 West Dry Creek Circle - Littleton
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 623 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05382299
The ClinicalTrials.gov registry entry for NCT05382299 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 623 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (159% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05382299 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT05382299 about?
NCT05382299 is a clinical study titled "Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice 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) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors ...
What is the current status of trial NCT05382299?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 623 participants. The study started on 2022-07-20. Estimated completion is 2028-07.
What conditions does trial NCT05382299 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, PD-L1 Negative.
What interventions are being tested in trial NCT05382299?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG), Sacituzumab Govitecan-hziy (DRUG), nab-Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT05382299?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05382299 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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