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
Condition(s) studied
Investigational drug(s) / intervention(s)
Sacituzumab Govitecan-hziy: Administered intravenously
Paclitaxel: Administered intravenously
Nab-paclitaxel: Administered intravenously
Capecitabine: Administered orally
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).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) — Up to approximately 29 months
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.
Trial sites (288)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | Chandler | Arizona | |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | |
| Stanford Cancer Institute | Palo Alto | California | |
| University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco | California | |
| Rocky Mountain Cancer Centers, LLP | Littleton | Colorado | |
| Yale-New Haven Hospital-Yale Cancer Center | New Haven | Connecticut | |
| Investigational Drug Services, AdventHealth Orlando | Altamonte Springs | Florida | |
| Florida Cancer Specialists | Brooksville | Florida | |
| Florida Cancer Specialist | Leesburg | Florida | |
| Florida Cancer Specialist | St. Petersburg | Florida | |
| Piedmont Cancer Institute | Atlanta | Georgia | |
| Georgia Cancer Specialist - Annex | Atlanta | Georgia | |
| Northwest Georgia Oncology Centers | Marietta | Georgia | |
| The University of Kansas Hospital | Kansas City | Kansas | |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | |
| Saint Luke's Cancer Institute | Kansas City | Missouri | |
| David C. Pratt Cancer Center | St Louis | Missouri | |
| Astera Cancer Care | East Brunswick | New Jersey | |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | |
| Penn State Cancer Institute | Hershey | Pennsylvania | |
| Magee-Womens of UPMC | Pittsburgh | Pennsylvania | |
| Prisma Health - Upstate | Greenville | South Carolina | |
| Tennessee Oncology, PLLC | Nashville | Tennessee | |
| Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | |
| US Oncology Investigational Products Center (IPC) | Fairfax | Virginia | |
| US Oncology Investigational Products Center (IPC) | Norfolk | Virginia | |
| MultiCare Regional Cancer Center - Auburn | Auburn | Washington | |
| Hospital Britanico de Buenos Aires | Buenos Aires | Argentina | |
| Instituto de Investigaciones Clinicas de Mar del Plata | Buenos Aires | Argentina | |
| Instituto Alexander Fleming | C.a.b.a. | Argentina | |
| Hospital Alemán | CABA | Argentina | |
| Centro Privado de RMI Rio Cuarto S.A. | Córdoba | Argentina | |
| Instituto de Oncología de Rosario | Rosario | Argentina | |
| CER San Juan Centro Polivalente de Asistencia e Investigación Clínica | San Juan | Argentina | |
| Royal Brisbane and Women's Hospital | Queensland | ME | |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | |
| Liverpool Hospital | Liverpool | New South Wales |
+ 248 more sites — see the full list on the official registry below.
More Gilead Sciences trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05840211 on ClinicalTrials.gov ↗ ← All trials in Spain