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NCT05840211 · ClinicalTrials.gov registry record · Phase 3
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
A Phase 3 study of Stage IV Breast Cancer and Locally Advanced or Unresectable Metastatic Breast Cancer, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 654
- Enrollment target
- 20
- Study locations
NCT05840211: Active Phase 3 study of Stage IV Breast Cancer and Locally Advanced or Unresectable Metastatic Breast Cancer, sponsored by Gilead Sciences.
NCT05840211 is a Phase 3 study of Stage IV Breast Cancer and Locally Advanced or Unresectable Metastatic Breast Cancer that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 654 participants, above the 45-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (1353% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05840211, a Phase 3 study of Stage IV Breast Cancer and Locally Advanced or Unresectable Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 654 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
Primary Outcome
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- DRUG Sacituzumab Govitecan-hziy
Study Locations (20)
Florida
- Investigational Drug Services, AdventHealth Orlando - Altamonte Springs
- Florida Cancer Specialists - Brooksville
- Florida Cancer Specialist - Leesburg
- Florida Cancer Specialist - St. Petersburg
California
- Los Angeles Hematology Oncology Medical Group - Los Angeles
- Stanford Cancer Institute - Palo Alto
- University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center - San Francisco
Georgia
- Piedmont Cancer Institute - Atlanta
- Georgia Cancer Specialist - Annex - Atlanta
- Northwest Georgia Oncology Centers - Marietta
Missouri
- Saint Luke's Cancer Institute - Kansas City
- David C. Pratt Cancer Center - St Louis
New Jersey
- Astera Cancer Care - East Brunswick
- Rutgers Cancer Institute of New Jersey - New Brunswick
Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Chandler
Colorado
- Rocky Mountain Cancer Centers, LLP - Littleton
Connecticut
- Yale-New Haven Hospital-Yale Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2028-04 |
| Phase | Phase 3 |
What the registry record for NCT05840211 still lists
NCT05840211 is an interventional study that assigns participants to a tested intervention. The registered 654 participants enrollment target is mid-sized for trials with a published cap, above the 45-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (1353% higher).
The record links to 2 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.
NCT05840211 names 20 study sites across 11 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05840211 about?
NCT05840211 is a clinical study titled "Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy". The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. ...
What is the current status of trial NCT05840211?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2023-05-08. Estimated completion is 2028-04.
What conditions does trial NCT05840211 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Locally Advanced or Unresectable Metastatic Breast Cancer.
What interventions are being tested in trial NCT05840211?
The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Sacituzumab Govitecan-hziy (DRUG).
Who is sponsoring clinical trial NCT05840211?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05840211 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV 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 NCT05840211's enrollment target sits among peer trials
654 1st of 30 higher than 30 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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