Open Actively Recruiting

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
    • 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 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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
22-000900
Category
Hematology-Oncology
Oncology
Contact
Monica Rocha
Location
  • TRIO-US - Ft. Wayne IN
  • TRIO-US - Redondo Beach
  • UCLA Alhambra
  • UCLA Beverly Hills
  • UCLA Burbank
  • UCLA Laguna Hills
  • UCLA Parkside
  • UCLA Pasadena
  • UCLA San Luis Obispo
  • UCLA Santa Monica
  • UCLA Ventura
  • UCLA Westlake Village
  • UCLA Westwood
For Providers
NCT No.
NCT05382299
For detailed technical eligibility, visit ClinicalTrials.gov.