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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
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
Sacituzumab Govitecan-hziy
Administered intravenously
Paclitaxel
Administered intravenously
Nab-paclitaxel
Administered intravenously
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