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Активно (без набиране) Фаза 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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Triple Negative Breast Cancer PD-L1 Positive

Спонсор: Gilead Sciences

Налично на: БГ
Обобщение
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).
Кой може да участва
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.
Места на провеждане 27
Argentina (1)
Hospital Británico de Buenos Aires
Buenos Aires
Австралия (1)
Border Medical Oncology
Albury , New South Wales
Белгия (1)
Institut Jules Bordet
Anderlecht
Бразилия (1)
Hospital Araújo Jorge - Associacao de Combate ao Cancer em Goias - ACCG
Goiânia
Канада (1)
Tom Baker Cancer Centre
Calgary
Chile (1)
Oncovida - Santiago
Providencia
Чехия (1)
Masarykuv Onkologicky Ustav, Klinika Komplexni Onkologicke Pece
Brno
Франция (1)
Sainte Catherine Institut du Cancer Avignon Provence
Avignon
Германия (1)
Helios Klinikum Berlin-Buch
Berlin
Hong Kong (1)
Department of Medicine, Queen Mary Hospital
Hong Kong
Унгария (1)
Orszagos Onkologiai Intezet
Budapest
Израел (1)
Soroka Medical Center
Beersheba
Италия (1)
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari
Япония (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
Нидерландия (1)
Amphia Ziekenhuis - Breda Langendijk
Breda
Полша (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
Южна Корея (1)
National Cancer Center - Korea
Goyang-si Gyeonggi-do
Испания (1)
Hospital Teresa Herrera - Materno Infantil
A Coruña
Швейцария (1)
Kantonsspital Baden
Baden
Taiwan (1)
Changhua Christian Hospital
Changhua
Турция (1)
Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi
Adana
Великобритания (1)
NHS Lothian
Edinburgh
САЩ (1)
Alaska Oncology and Hematology
Anchorage , Alaska
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
25.07.2022
Крайна дата
01.02.2027
Регистрационен номер
NCT05382286
Източник
anzctr
Запитване за медицински туризъм

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