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NCT02574455 · ClinicalTrials.gov registry record · Phase 3
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
A Phase 3 study of Breast Cancer, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
- 20
- Study locations
NCT02574455: Completed Phase 3 study of Breast Cancer, sponsored by Gilead Sciences.
NCT02574455 is a Phase 3 study of Breast Cancer that has completed, run by Gilead Sciences. The registered enrollment target is 529 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02574455, a Phase 3 study of Breast Cancer, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.
Primary Outcome
PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to \[≥\] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Capecitabine
- DRUG Gemcitabine
- DRUG Eribulin
- DRUG Vinorelbine
Study Locations (20)
California
- UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200 - Alhambra
- UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200 - Burbank
- UCLA Jonsson Comprehensive Cancer Center - Laguna Hills
- UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza - Los Angeles
- UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320 - Pasadena
- University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street - San Francisco
- UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard - Santa Monica
Colorado
- Rocky Mountain Cancer Centers, 1700 South Potomac Street - Aurora
- University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court - Aurora
- Rocky Mountain Cancer Centers, 4715 Arapahoe Ave - Boulder
- Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400 - Colorado Springs
- Rocky Mountain Cancer Centers, 1800 Williams St. - Denver
- Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400 - Denver
- Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450 - Englewood
Alabama
- Southern Cancer Center, 29653 Anchor Cross Blvd - Daphne
- Souther Cancer Center, 3719 Dauphin St., 5 Floor - Mobile
- Southern Cancer Center, 3 Mobile Infirmary Circle - Mobile
- Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level - Mobile
Arizona
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic Hospital - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2020-12-08 |
| Phase | Phase 3 |
What the finished NCT02574455 record still lists
NCT02574455 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Sacituzumab govitecan is the first listed.
NCT02574455 names 20 study sites across 4 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT02574455 about?
NCT02574455 is a clinical study titled "Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)". The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-neg...
What is the current status of trial NCT02574455?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2017-11-07. Estimated completion is 2020-12-08.
What conditions does trial NCT02574455 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02574455?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Capecitabine (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT02574455?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02574455 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02574455's enrollment target sits among peer trials
529 187th of 1224 higher than 1,038 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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