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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Triple Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Anchorage

Alaska Oncology and Hematology, Anchorage, Alaska, United States, 99508

Tucson

Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd, Tucson, Arizona, United States, 85704

Tucson

Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd., Tucson, Arizona, United States, 85704

Tucson

Arizona Oncology Associates, PC-Hope, Tucson, Arizona, United States, 85711

Tucson

Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road, Tucson, Arizona, United States, 85745

Hot Springs

Genesis Cancer and Blood Institute,1455 Higdon Ferry Road Suite B., Hot Springs, Arkansas, United States, 71913

Hot Springs

Genesis Cancer and Blood Institute, Hot Springs, Arkansas, United States, 71913

Jonesboro

Saint Bernards Medical Center, Jonesboro, Arkansas, United States, 72401

Paragould

Saint Bernards Medical Center,4000 Linwood Drive, Paragould, Arkansas, United States, 72450

Burbank

University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200, Burbank, California, United States, 91505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2028-07