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 Sex
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

More Details

Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact