Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab 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
Pembrolizumab: 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) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (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 33 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 (504)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Oncology and Hematology | Anchorage | Alaska | |
| 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 | |
| Genesis Cancer and Blood Institute | Hot Springs | Arkansas | |
| Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B. | Hot Springs | Arkansas | |
| Saint Bernards Medical Center | Jonesboro | Arkansas | |
| Saint Bernards Medical Center,4000 Linwood Drive | Paragould | Arkansas | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 | Burbank | California | |
| University of California Irvine Health Chao Family,1640 Newport Blvd | Costa Mesa | California | |
| City of Hope | Duarte | 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 | |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | |
| City of Hope,1601 Avocado Ave | Newport | California | |
| University of California Irvine Health Chao Family | Orange | California | |
| City of Hope,209 Fair Oaks Ave | Pasadena | California | |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 | San Luis Obispo | California | |
| Sansum Clinic | Santa Barbara | 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 | |
| St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare | Santa Rosa | California | |
| Sansum Clinic,2040 Viborg Road | Solvang | California | |
| City of Hope,5215 Torrance Blvd | Torrance | California | |
| Torrance Memorial Physician Network - Cancer Care | Torrance | California | |
| City of Hope,1100 San Bernardino Rd | Upland | 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 |
+ 464 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
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 NCT05382286 on ClinicalTrials.gov ↗ ← All trials in Czechia