Last updated 5 months ago
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
540 patients around the world
Available in Argentina, Puerto Rico, Mexico, United States, Spain
Gilead Sciences
22Research sites
540Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 settingCentrally confirmed TNBC and PD-L1 status on fresh or archival tissueIndividuals 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 recurrenceIndividuals presenting with de novo metastatic TNBC are eligibleMeasurable 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 locallyEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Demonstrates adequate organ functionMale individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraceptionIndividuals 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 lactatingReceived systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollmentHave not recovered from adverse events (AEs) due to a previously administered agent at the time study entryMay 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 eligiblePreviously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitorActive second malignancyActive serious infection requiring antibioticsPositive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman DiseaseActive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Centro Médico Caipo (centro para la atención integral de pacientes oncológicos)
Recruiting
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
FAICIC Clinical Research
Recruiting
Oncológico Potosino
Recruiting
iBiomed Investigación Biomédica Guadalajara
Recruiting
Panamerican Clinical Research S.A. de C.V
Recruiting
StudyASCENT-03
SponsorGilead Sciences
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05382299
