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Brief Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
Official Title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens
Study ID: NCT03901339
Brief Summary: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research Institute, Avondale, Arizona, United States
Arizona Oncology Associates, PC, Tucson, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
University of California, San Diego Moores Cancer Center, La Jolla, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology, Los Angeles, California, United States
University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center, Orange, California, United States
Southern California Permanente Medical Group, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
University of Colorado, Aurora, Colorado, United States
Yale University Cancer Center, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
Northside Hospital, Inc., Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
Mercy Medical Center, Medical Oncology & Hematology, Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A., Rockville, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Allina Health, Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Summit Medical Group, Florham Park, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
The Ohio State University, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
The West Clinic, PC dba West Cancer Center, Germantown, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
Texas Oncology-Denton South, Denton, Texas, United States
Houston Methodist Hospital/Houston Methodist Cancer Center, Houston, Texas, United States
Texas Oncology-Longview Cancer Center, Longview, Texas, United States
UT Health San Antonio - Mays Cancer Center, San Antonio, Texas, United States
Virginia Cancer Specialists, Arlington, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care, Salem, Virginia, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Chirec Cancer Institute, Brussels, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
CHU UCL Namur/Site Sainte Elisabeth, Namur, , Belgium
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Centre Hospitalier de L'Universite de Montreal - HÎpital Notre-Dame, Montréal, , Canada
Centre Hospitalier Universitaire de Sherbrooke - Fleurimont, Sherbrooke, , Canada
Hopital de Mercy, Ars-Laquenexy, , France
Institut Sainte Catherine, Avignon, , France
HÎpital Jean-Minjoz, Besançon, , France
Centre Georges-Francois Leclerc, Dijon, , France
Centre Leon Berard, Lyon, , France
Institut RĂ©gional du Cancer de Montpellier, Montpellier, , France
Institut Curie, Paris, , France
Hospices Civils de Lyon, Pierre-BĂ©nite, , France
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, , France
Institut Claudius Regaud, Toulouse, , France
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Gynakologisches Zentrum Bonn, Bonn, , Germany
Marienhospital Bottrop, Bottrop, , Germany
StÀdtisches Klinikum Dessau, Dessau, , Germany
UniversitÀtsklinikum Erlangen, Erlangen, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Centrum fĂŒr HĂ€matologie und Onkologie Bethanien, Frankfurt, , Germany
Onkologische Schwerpunktpraxis Eppendorf, Hamburg, , Germany
Gynakologisch-Onkologische Praxis Hannover, Hannover, , Germany
DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode, Hannover, , Germany
Nationales Centrum fĂŒr Tumorerkrankungen - Heidelberg, Heidelberg, , Germany
Praxisklinik fĂŒr HĂ€matologie und Onkologie Koblenz, Koblenz, , Germany
UniversitÀtsmedizin Mannheim, Mannheim, , Germany
Klinikum Mutterhaus der BorromÀerinnen, Trier, , Germany
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
Ospedale di Desio, Desio, , Italy
Ospedale Vito Fazzi di Lecce, Lecce, , Italy
Ospedale San Raffaele, Milano, , Italy
Azienda Ospedaliera San Gerardo di Monza, Monza, , Italy
Azienda UnitĂ Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto, Piacenza, , Italy
IFO Istituto Nazionale dei Tumori Regina Elena, Rome, , Italy
Antoni van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Medisch Centrum Haaglanden Antoniushove, Leidschendam, , Netherlands
Maastricht UMC+, Maastricht, , Netherlands
Complejo Hospitalario Universitario A Coruna, A Coruña, , Spain
Hospital QuirĂłnsalud Barcelona Instituto Oncologico Baselga, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Provincial de CastellĂłn, CastillĂłn, , Spain
Hospital Universitari Arnau de Vilanova, Lleida, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Instituto Oncologico Bureau (IOB), Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario de Santiago de Compostela, Santiago De Compostela, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Royal Cornwall Hospital NHS Trust, Cornwell, , United Kingdom
Royal Surrey County Hospital, Guildford, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR