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
Public ClinicalTrials.gov record NCT05840211. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05840211
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 654 participants
Conditions and interventions
Interventions
- Sacituzumab Govitecan-hziy Drug
- Paclitaxel Drug
- Nab-paclitaxel Drug
- Capecitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 8, 2023 (Actual)
- Primary completion
- Apr 2028 (Estimated)
- Completion
- Apr 2028 (Estimated)
- Last update posted
- Oct 3, 2025
2023 – 2028
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | 90017 | — |
| Stanford Cancer Institute | Palo Alto | California | 94305 | — |
| University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| Rocky Mountain Cancer Centers, LLP | Littleton | Colorado | 80120 | — |
| Yale-New Haven Hospital-Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Investigational Drug Services, AdventHealth Orlando | Altamonte Springs | Florida | 32701 | — |
| Florida Cancer Specialists | Brooksville | Florida | 34613 | — |
| Florida Cancer Specialist | Leesburg | Florida | 34748 | — |
| Florida Cancer Specialist | St. Petersburg | Florida | 33705 | — |
| Piedmont Cancer Institute | Atlanta | Georgia | 30318 | — |
| Georgia Cancer Specialist - Annex | Atlanta | Georgia | 30341 | — |
| Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | — |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | 70809 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64110 | — |
| David C. Pratt Cancer Center | St Louis | Missouri | 63141 | — |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | 10065 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43210 | — |
| Penn State Cancer Institute | Hershey | Pennsylvania | 17033 | — |
| Magee-Womens of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Prisma Health - Upstate | Greenville | South Carolina | 29605 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37203 | — |
| US Oncology Investigational Products Center (IPC) | Fairfax | Virginia | 22031 | — |
| US Oncology Investigational Products Center (IPC) | Norfolk | Virginia | 23502 | — |
| MultiCare Regional Cancer Center - Auburn | Auburn | Washington | 98001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 258 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05840211, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 3, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05840211 live on ClinicalTrials.gov.