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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05840211
The ClinicalTrials.gov registry entry for NCT05840211 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (1353% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.