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
Purpose
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).
Conditions
- Triple Negative Breast Cancer
- PD-L1 Positive
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. - Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. - Individuals presenting with de novo metastatic TNBC are eligible for this study. - TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. - Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Demonstrates adequate organ function - Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Exclusion Criteria
- Positive serum pregnancy test or women who are lactating. - Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor. - Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. - Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible. - Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. - Have an active second malignancy. - Have active serious infection requiring antibiotics. - Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. - Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Sacituzumab Govitecan-hziy (SG) + Pembrolizumab |
Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles. |
|
Active Comparator Pembrolizumab + Treatment of Physician's Choice (TPC) |
Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: - Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles - nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles - Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles |
|
Recruiting Locations
The University of Kansas Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
The University of Kansas Cancer Center,2000 Olathe Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
The University of Kansas Cancer Center,8700 North Green Hills Road
Kansas City, Missouri 64154
Kansas City, Missouri 64154
The University of Kansas Cancer Center,2750 Clay Edwards Drive
Kansas City, Missouri 64116
Kansas City, Missouri 64116
The University of Kansas Cancer Center,4881 N.E. Goodview Circle
Lee's Summit, Missouri 64064
Lee's Summit, Missouri 64064
The University of Kansas Cancer Center,10710 Nall Avenue
Overland Park, Kansas 66211
Overland Park, Kansas 66211
The University of Kansas Cancer Center,10730 Nall Avenue
Overland Park, Kansas 66211
Overland Park, Kansas 66211
The University of Kansas Cancer Center,12200 W. 110th Street
Overland Park, Kansas 66210
Overland Park, Kansas 66210
More Details
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com