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
Purpose
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.
Conditions
- Triple Negative Breast Cancer
- PD-L1 Negative
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) - Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity - Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue - Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence - Individuals presenting with de novo metastatic TNBC are eligible - Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Demonstrates adequate organ function - Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception - Individuals with human immunodeficiency virus (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 systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment - Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry - 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 - Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor - Active second malignancy - Active serious infection requiring antibiotics - Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease - Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 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) |
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. |
|
Active Comparator Treatment of Physician's Choice (TPC) |
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens: - Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle - Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle - Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle |
|
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,2750 Clay Edwards Drive
Kansas City, Missouri 64116
Kansas City, Missouri 64116
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,10710 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
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,10730 Nall Avenue
Overland Park, Kansas 66211
Overland Park, Kansas 66211
More Details
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com