Last updated 4 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 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
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

Sites

Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
25 de mayo 174, Viedma, Río Negro
Hospital Británico de Buenos Aires - CABA
Hospital Británico de Buenos Aires - CABA
Recruiting
Perdriel 74, CABA, Buenos Aires
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Dorrego 269, La Rioja
Centro Médico Caipo (centro para la atención integral de pacientes oncológicos)
Recruiting
Av Sarmiento 157, San Miguel de Tucumán
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Recruiting
Av. San Martín 5481, CABA, Buenos Aires
Instituto de Oncología de Rosario - IOR
Recruiting
Córdoba 2457, Rosario, Santa Fe
FAICIC Clinical Research
FAICIC Clinical Research
Recruiting
Av. 16 de Septiembre 1165, Ricardo Flores Magón, 91900 Veracruz, Veracruz
Oncológico Potosino
Oncológico Potosino
Recruiting
Mariano Arista 965, San Luis Potosí
iBiomed Investigación Biomédica Guadalajara
Recruiting
Av. Sebastian Bach 5257, La Estancia, Zapopan, Jalisco
Panamerican Clinical Research S.A. de C.V
Recruiting
Guadalajara, 44670
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