Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Sacituzumab Govitecan-hziy: Administered intravenously
Paclitaxel: Administered intravenously
nab-Paclitaxel: Administered intravenously
Gemcitabine: Administered intravenously
Carboplatin: Administered intravenously
Study summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — Randomization up to approximately 57 months
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
Trial sites (363)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd | Tucson | Arizona | |
| Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd. | Tucson | Arizona | |
| Arizona Oncology Associates, PC-Hope | Tucson | Arizona | |
| Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road | Tucson | Arizona | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 | Burbank | California | |
| University of California San Diego Moores Cancer | La Jolla | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 | Laguna Hills | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 | San Luis Obispo | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600 | Santa Monica | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304 | Santa Monica | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center | Santa Monica | California | |
| Torrance Memorial Physician Network - Cancer Care | Torrance | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100 | Westlake Village | California | |
| Rocky Mountain Cancer Centers,1700 South Potomac Street | Aurora | Colorado | |
| Rocky Mountain Cancer Centers | Boulder | Colorado | |
| Rocky Mountain Cancer Centers,2312 N. Nevada Avenue | Colorado Springs | Colorado | |
| Rocky Mountain Cancer Centers,6031 E. Woodman Rd. | Colorado Springs | Colorado | |
| Rocky Mountain Cancer Centers,4700 E. Hale Parkway | Denver | Colorado | |
| Rocky Mountain Cancer Centers,11750 West 2nd Place | Lakewood | Colorado | |
| Rocky Mountain Cancer Centers,22 West Dry Creek Circle | Littleton | Colorado | |
| Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway | Lone Tree | Colorado | |
| Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210 | Longmont | Colorado | |
| Rocky Mountain Cancer Centers,3676 Parker Blvd | Pueblo | Colorado | |
| Rocky Mountain Cancer Centers,525 W. 15th Street | Pueblo | Colorado | |
| Rocky Mountain Cancer Centers,8820 Huron Street | Thornton | Colorado | |
| AdventHealth Medical Group | Altamonte Springs | Florida | |
| Florida Cancer Specialists - North Region Research Office,750 Orienta Ave | Altamonte Springs | Florida | |
| Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A | Bonita Springs | Florida | |
| Florida Cancer Specialists,3630 Manatee Avenue West | Bradenton | Florida | |
| Florida Cancer Specialists,5985 Silver Falls Run | Bradenton | Florida | |
| Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave. | Brandon | Florida | |
| Florida Cancer Specialists,1030 Commerce Creek Blvd | Cape Coral | Florida | |
| Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road | Clearwater | Florida | |
| Florida Cancer Specialists | Fort Myers | Florida | |
| Florida Cancer Specialists,8981 Colonial Center Drive | Fort Myers | Florida | |
| Florida Cancer Specialists,8260 Gladiolus Dr | Fort Myers | Florida | |
| Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road | Gainesville | Florida | |
| Florida Cancer Specialists - North Region Research Office,100 Highland Avenue | Largo | Florida | |
| Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway | Lecanto | Florida | |
| Florida Cancer Specialists,1100 Goodlette Road | Naples | Florida |
+ 323 more sites — see the full list on the official registry below.
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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 NCT05382299 on ClinicalTrials.gov ↗ ← All trials in Czechia