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ACTIVE NOT RECRUITING
NCT05840211
PHASE3

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Official title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

654

Start Date

2023-05-08

Completion Date

2028-04

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab Govitecan-hziy

Administered intravenously

DRUG

Paclitaxel

Administered intravenously

DRUG

Nab-paclitaxel

Administered intravenously

DRUG

Capecitabine

Administered orally

Locations (288)

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, United States

Yale-New Haven Hospital-Yale Cancer Center

New Haven, Connecticut, United States

Investigational Drug Services, AdventHealth Orlando

Altamonte Springs, Florida, United States

Florida Cancer Specialists

Brooksville, Florida, United States

Florida Cancer Specialist

Leesburg, Florida, United States

Florida Cancer Specialist

St. Petersburg, Florida, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Georgia Cancer Specialist - Annex

Atlanta, Georgia, United States

Northwest Georgia Oncology Centers

Marietta, Georgia, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

David C. Pratt Cancer Center

St Louis, Missouri, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Magee-Womens of UPMC

Pittsburgh, Pennsylvania, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

US Oncology Investigational Products Center (IPC)

Fairfax, Virginia, United States

US Oncology Investigational Products Center (IPC)

Norfolk, Virginia, United States

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de Mar del Plata

Buenos Aires, Argentina

Instituto Alexander Fleming

C.a.b.a., Argentina

Hospital Alemán

CABA, Argentina

Centro Privado de RMI Rio Cuarto S.A.

Córdoba, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigación Clínica

San Juan, Argentina

Royal Brisbane and Women's Hospital

Queensland, ME, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

GenesisCare North Shore (Oncology)

St Leonards, New South Wales, Australia

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Icon Cancer Centre Hobart

Hobart, Tasmania, Australia

Austin Health

Melbourne, Victoria, Australia

Sunshine Hospital (Western Health)

St Albans, Victoria, Australia

Breast Cancer Research Centre - WA

Nedlands, Western Australia, Australia

University Hospital Innsbruck

Innsbruck, Austria

Universitätsklinik für Innere Medizin 3 der PMU

Salzburg, Austria

Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie

Vienna, Austria

Klinikum Wels-Grieskirchen

Wels, Austria

GZA Ziekenhuizen - Campus Sint-Augustinus

Antwerp, Belgium

AZ Klina

Brasschaat, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitaire Ziekenhuis Leuven

Leuven, Belgium

CHU UCL Namur-Site STE. Elisabeth

Namur, Belgium

Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

Fortaleza, Brazil

Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias

Goiânia, Brazil

Oncosite - Centro de Pesquisa Clinica e Oncologia

Ijuí, Brazil

Catarina Pesquisa Clinica

Itajaí, Brazil

Oncoclinicas do Brasil Servicos Medicos AS

Minas Gerais, Brazil

Liga Norte-Rio-Grandense Contra o Câncer

Natal, Brazil

CIONC-Centro Integrado de Oncologia de Curitiba

Paraana, Brazil

Hospital Erasto Gaertner

Paraná, Brazil

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Pernambuco, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Hospital de Clínicas de Porto Alegre - HCPA

Porto Alegre, Brazil

HGB - Hospital Giovanni Battista/Mãe de Deus Center

Porto Alegre, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Brazil

Instituto Americas

Rio de Janeiro, Brazil

Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO

Rio Grande, Brazil

Unidade de PesquisasClinicas em Oncologia - UPCO

Rio Grande, Brazil

Instituto do Câncer - Hospital São Vicente de Paulo

Rio Grande, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, Brazil

Instituto Hemomed Oncologia e Hematologia

São Paulo, Brazil

Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria

São Paulo, Brazil

BC Cancer - Kelowna

Kelowna, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Canada

CHU de Québec-Université Laval, Hôpital du Saint-Sacrement

Québec, Canada

Humber River Hospital

Toronto, Canada

BC Cancer-Victoria

Victoria, Canada

Centro de Investigacion Clinica Bradford Hill

Recoleta, Chile

Centro del Cancer UC

Region Metropolitana, Chile

Centro de Oncología de Precisión (COP)

Santiago Region, Chile

James Lind Centro de Investigacion del Cancer

Temuco, Chile

Oncocentro APYS

Viña del Mar, Chile

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Anhui, China

Peking University People's Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Xiangya Hospital Central South University

Changsha, China

West China Hospital Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Fujian Cancer Hospital

Fujian, China

Fujian Medical University Union Hospital

Fuzhou, China

Sun Yat-Sen University Cancer Center

Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, China

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

And 188 more locations on ClinicalTrials.gov