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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

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

ArmDescriptionAssigned Intervention
Experimental
Sacituzumab Govitecan-hziy (SG) 		Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
  • Drug: Sacituzumab Govitecan-hziy
    Administered intravenously
    Other names:
    • IMMU-132
    • Trodelvy™
    • GS-0132
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
  • Drug: Paclitaxel
    Administered intravenously
  • Drug: nab-Paclitaxel
    Administered intravenously
    Other names:
    • Abraxane®
  • Drug: Gemcitabine
    Administered intravenously
  • Drug: Carboplatin
    Administered intravenously

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02215

Massachusetts General Hospital,2014 Washington St
Newton, Massachusetts 02462

Massachusetts General Hospital,102 Endicott Street
Danvers, Massachusetts 01923

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.