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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

Harbin Medical University Cancer Hospital

Heilongjiang, China

Jiangsu Province Hospital

Jiangsu, China

The First Affiliated Hospital of Soochow University

Jiangsu, China

The Nanchang Third Hospital

Jiangxi, China

The Second Hospital of Jilin University

Jilin Sheng, China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

General Hospital of Ningxia Medical University

Ningxia Hui, China

The Affiliated Hospital Of Qingdao University

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni Nemocnice Brno

Brno, Czechia

Masaryk Memorial Cancer Institute

Brno, Czechia

University Hospital Olomouc

Olomouc, Czechia

Multiscan s.r.o

Pardubice, Czechia

Charles General University Hospital, Prague

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Krajska nemocnice Tomase Bati Zlin

Zlín, Czechia

CHU Jean Minjoz

Besançon, France

Institut Bergonié

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Clinique Francois Chenieux

Limoges, France

Ico René Gauducheau

Loire Atlantique, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Institut Regional du Cancer de Montpellier

Montpellier, France

Institut Curie

Paris, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Hopital Privé des Cotes d'Armor

Plérin, France

Centre Jean Bernard Service d'Oncologie Médicale

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde

Baden-Württemberg, Germany

University Hospital rechts der Isar Technical University of Munich

Bayern, Germany

Vivantes Klinikum am Urban

Berlin, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Marienhospital Bottrop

Bottrop, Germany

Universitätsklinik Erlangen

Erlangen, Germany

SRH Wald-Klinikum Gera GmbH

Gera, Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Nationales Centrum für Tumorerkrankungen Heidelberg

Heidelberg, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

LMU Klinikum der Universitat München

München, Germany

Universitatsklinikum Munster

Münster, Germany

Universitäts - Frauenklinik

Tübingen, Germany

Alexandra General Hospital

Athens, Greece

Attikon Hospital

Athens, Greece

University Hospital of Heraklion

Heraklion, Greece

University Hospital of Larissa

Larissa, Greece

University Hospital of Patras

Pátrai, Greece

Bioclinic of Thessaloniki

Thessaloniki, Greece

Euromedica General Clinic of Thessaloniki

Thessaloniki, Greece

Hong Kong Integrated Oncology Centre

Hong Kong, Hong Kong

Prince of Wales Hospital

New Territories, Hong Kong

Queen Mary Hospital

Pok Fu Lam, Hong Kong

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, Hungary

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary

Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont

Kecskemét, Hungary

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia

Nyíregyháza, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary

Oncology Institute Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona AN, Italy

Centro di Riferimento Oncologico - IRCCS

Aviano, Italy

Humanitas Gavazzeni

Bergamo, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

Bologna, Italy

Humanitas Istituto Clinico Catanese

Catania, Italy

Azienda Ospedaliera Mater Domini

Catanzaro, Italy

IRCCS Ospedale Policlinico San Martino

Genova GE, Italy

Istituto Europeo di Oncologia

Milan, Italy

Fondazione IRCCS San Raffaele del Monte Tabor

Milan, Italy

Azienda Ospedaliera San Gerardo

Monza, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Istituto Oncologico Veneto IOV

Padova, Italy

Irccs Crob

Rionero in Vulture, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Aichi Cancer Center Hospital

Aichi, Japan

Tohoku University Hospital

Aoba-ku, Japan

Juntendo University Hospital

Bunkyō City, Japan

Chiba Cancer Center

Chiba, Japan

National Cancer Center Hospital

Chūōku, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Chūōku, Japan

National Hospital Organization Shikoku Cancer Center

Ehime, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Japan

Tokai University Hospital

Kanagawa, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Saitama Cancer Center

Kitaadachi-gun, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kyoto University Hospital

Kyoto, Japan

National Hospital Organization Kyushu Cancer Center

Minamiku, Japan

Nagoya University Hospital

Nagoya, Japan

Hiroshima City Hiroshima Citizens Hospital

Nakaku, Japan

Hyogo Medical University Hospital

Nishinomiya-shi, Japan

Okayama University Hospital

Okayama, Japan

Gunma Prefectural Cancer Center

Ōta-ku, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Japan

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Japan

Showa University Hospital

Tokyo, Japan

Kanagawa Cancer Center

Yokohama, Japan

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Malaysia

Institut Kanser Negara

Putrajaya, Malaysia

Centro de Investigacion y Avances Medicos Especializados

Cancún, Mexico

COI Centro Oncologico Internacional S.A.P.I. de C.V.

Mexico City, Mexico

FUCAM

México, Mexico

Hospital Universitario Dr. José Eleuterio González

Monterrey, Mexico

Clinica Integral Internacional de Oncologia S de RL de CV

Puebla City, Mexico

Centro Medico Zambrano Hellion

San Pedro Garza García, Mexico

Centro de Atención e Investigación Clínica en Oncología

Yucatán, Mexico

Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku

Gdansk, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o

Krakow, Poland

Instytut MSF Sp. z o.o.

Lodz, Poland

Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie

Lublin, Poland

LUX MED Onkologia Sp. Zo.o.

Warsaw, Poland

Maria Sklodowska - Curie Institute of Oncology

Warsaw, Poland

Centro Clinico Academico - Hospital de Braga

Braga, Portugal

Hospital da Senhora da Oliveira Guimaraes

Guimarães, Portugal

Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos

Lisbon, Portugal

Fundacao Champalimaud

Lisbon, Portugal

Centro Hospitalar Lisboa Norte, EPE

Lisbon, Portugal

Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano

Matosinhos Municipality, Portugal

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Wilgers Oncology Centre

Gauteng, South Africa

Wits Clinical Research

Johannesburg, South Africa

The Medical Oncology Centre of Rosebank

Johannesburg, South Africa

Cape Town Oncology Trials

Kraaifontein, South Africa

Samsung Medical Center

Gangnam-Gu, South Korea

National Cancer Center

Goyang-si Gyeonggi-do, South Korea

Kyungpook National University Chilgok Hospital

Gyeongsangbuk-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitari Dexeus

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital de Basurto

Bilbao, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital General Universitario De Elche

Elche, Spain

Hospital Universitario de Jaen

Jaén, Spain

Hospital Beata María Ana

Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Clínico Universitario de Santiago de Compostela - CHUS

Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Instituto Valenciano De Oncologia (IVO)

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chi Mei Hospital, Liouying

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

Barts Cancer Institute

London, United Kingdom

University College London Hospitals

London, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom