GS-US-592-6238-A Randomized, Open-Label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.
Primary Objective:
- To compare PFS as assessed by BICR between sacituzumab govitecan (SG) versus TPC.
Secondary Objectives:
- To compare OS between the 2 arms.
- To compare ORR as assessed by BICR between the 2 arms.
- To compare DOR as assessed by BICR between the 2 arms.
- To compare TTR as assessed by BICR between the 2 arms.
- To compare safety and tolerability between the 2 arms.
- To compare time to deterioration in global health status/QOL, pain, and fatigue as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30) between the 2 arms.
Nab-paclitaxel
Sacitzumab govitecan/IMMU-132
GEMCITABINE
CARBOPLATIN
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Monmouth Medical Center
- Robert Wood Johnson University Hospital, Somerset
Key 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
Key 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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.