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Active (not recruiting) Phase 3 NCT05382286

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Phase 3 – large-scale trial before approval
Conditions: Triple Negative Breast Cancer PD-L1 Positive

Sponsor: Gilead Sciences

trial.available_in: БГ
Overview
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Who can participate
Key Inclusion Criteria: * Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. * Individuals must have completed treatment for Stage I to 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 for this study. * TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. * Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Demonstrates adequate organ function * Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Individuals with 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 prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. * Individuals 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. * Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. * Have an active second malignancy. * Have active serious infection requiring antibiotics. * Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 27
Argentina (1)
Hospital Británico de Buenos Aires
Buenos Aires
Australia (1)
Border Medical Oncology
Albury , New South Wales
Belgium (1)
Institut Jules Bordet
Anderlecht
Brazil (1)
Hospital Araújo Jorge - Associacao de Combate ao Cancer em Goias - ACCG
Goiânia
Canada (1)
Tom Baker Cancer Centre
Calgary
Chile (1)
Oncovida - Santiago
Providencia
Czech Republic (1)
Masarykuv Onkologicky Ustav, Klinika Komplexni Onkologicke Pece
Brno
France (1)
Sainte Catherine Institut du Cancer Avignon Provence
Avignon
Germany (1)
Helios Klinikum Berlin-Buch
Berlin
Hong Kong (1)
Department of Medicine, Queen Mary Hospital
Hong Kong
Hungary (1)
Orszagos Onkologiai Intezet
Budapest
Israel (1)
Soroka Medical Center
Beersheba
Italy (1)
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari
Japan (1)
Aichi Cancer Center Hospital
Aichi
Malaysia (1)
Hospital Pulau Pinang
George Town
Mexico (1)
Icaro Investigaciones en Medicina S.A. de C.V.
Chihuahua City
Netherlands (1)
Amphia Ziekenhuis - Breda Langendijk
Breda
Poland (1)
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk
Puerto Rico (1)
Ponce Medical School Foundation Inc.
Ponce , PR
South Africa (1)
Hopelands Cancer Centre
Hilton
South Korea (1)
National Cancer Center - Korea
Goyang-si Gyeonggi-do
Spain (1)
Hospital Teresa Herrera - Materno Infantil
A Coruña
Switzerland (1)
Kantonsspital Baden
Baden
Taiwan (1)
Changhua Christian Hospital
Changhua
Turkey (1)
Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi
Adana
United Kingdom (1)
NHS Lothian
Edinburgh
United States (1)
Alaska Oncology and Hematology
Anchorage , Alaska
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.07.2022
Completion date
01.02.2027
Registry ID
NCT05382286
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.