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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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2022-07-25 |
| Est. Completion | 2027-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05382286
The ClinicalTrials.gov registry entry for NCT05382286 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 443 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 243-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (82% 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 Pembrolizumab is the first listed.
NCT05382286 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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