Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Triple Negative Breast Cancer and PD-L1 Negative, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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
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 |
What the registry record for NCT05382299 still lists
NCT05382299 is an interventional study that assigns participants to a tested intervention. The registered 623 participants enrollment target is mid-sized for trials with a published cap, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (159% higher).
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 names 20 study sites across 3 states, led by 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.
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 NCT05382299's enrollment target sits among peer trials
623 13th of 118 higher than 106 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
-
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)
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
RECRUITING · Phase 3
-
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
RECRUITING · 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
ACTIVE NOT RECRUITING · Phase 3
-
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
ACTIVE NOT RECRUITING · Phase 3
-
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06406049 · 624 participants · NA
Finishing HIV Project
- NCT05349227 · 625 participants · NA
Comprehensive Outcomes for After Cancer Health
- NCT06103864 · 625 participants · Phase 3
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
- NCT06230510 · 625 participants · NA
Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI