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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

654

Participants

Timeline

Start Date

May 8, 2023

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
Locally Advanced or Unresectable Metastatic Breast CancerStage IV Breast Cancer
Interventions
DRUG

Sacituzumab Govitecan-hziy

Administered intravenously

DRUG

Paclitaxel

Administered intravenously

DRUG

Nab-paclitaxel

Administered intravenously

DRUG

Capecitabine

Administered orally

Trial Locations (288)

0

Hong Kong Integrated Oncology Centre, Hong Kong

Queen Mary Hospital, Pok Fu Lam

161

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

235

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

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1083

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika, Budapest

1090

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

1118

Hospital Alemán, CABA

1200

Cliniques Universitaires Saint-Luc, Brussels

1426

Hospital Britanico de Buenos Aires, Buenos Aires

2000

Instituto de Oncología de Rosario, Rosario

2010

St Vincent's Hospital Sydney, Darlinghurst

2065

GenesisCare North Shore (Oncology), St Leonards

2170

Liverpool Hospital, Liverpool

2192

Wits Clinical Research, Johannesburg

2196

The Medical Oncology Centre of Rosebank, Johannesburg

2610

GZA Ziekenhuizen - Campus Sint-Augustinus, Antwerp

2930

AZ Klina, Brasschaat

3000

Universitaire Ziekenhuis Leuven, Leuven

3021

Sunshine Hospital (Western Health), St Albans

3084

Austin Health, Melbourne

3203

Hospital General Universitario De Elche, Elche

4029

Royal Brisbane and Women's Hospital, Queensland

4032

Debreceni Egyetem Klinikai Központ, Debrecen

4066

Icon Cancer Centre Wesley, Auchenflower

4400

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia, Nyíregyháza

4710

Klinikum Wels-Grieskirchen, Wels

4980

FUCAM, México

5000

CHU UCL Namur-Site STE. Elisabeth, Namur

5042

Flinders Medical Centre, Bedford Park

5400

CER San Juan Centro Polivalente de Asistencia e Investigación Clínica, San Juan

5800

Centro Privado de RMI Rio Cuarto S.A., Córdoba

6000

Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont, Kecskemét

6009

Breast Cancer Research Centre - WA, Nedlands

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7000

Icon Cancer Centre Hobart, Hobart

7570

Cape Town Oncology Trials, Kraaifontein

8035

Hospital Universitari Vall D'Hebron, Barcelona

10048

National Taiwan University Hospital, Taipei

10065

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

10408

National Cancer Center, Goyang-si Gyeonggi-do

10967

Vivantes Klinikum am Urban, Berlin

11217

Taipei Veterans General Hospital, Taipei

11490

Tri-Service General Hospital, Taipei

11528

Alexandra General Hospital, Athens

12808

Charles General University Hospital, Prague, Prague

13009

Institut Paoli Calmettes, Marseille

13125

HELIOS Klinikum Berlin-Buch, Berlin

13620

Seoul National University Bundang Hospital, Seongnam

14004

Hospital Universitario Reina Sofia, Córdoba

14059

Fakultni nemocnice v Motole, Prague

15213

Magee-Womens of UPMC, Pittsburgh

15706

Hospital Clínico Universitario de Santiago de Compostela - CHUS, Santiago de Compostela

16132

IRCCS Ospedale Policlinico San Martino, Genova GE

17033

Penn State Cancer Institute, Hershey

19713

Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie, Lublin

20089

Istituto Clinico Humanitas, Rozzano

20090

Azienda Ospedaliera San Gerardo, Monza

20132

Fondazione IRCCS San Raffaele del Monte Tabor, Milan

20141

Istituto Europeo di Oncologia, Milan

20246

Universitatsklinikum Hamburg-Eppendorf, Hamburg

21000

Centre Georges François Leclerc, Dijon

21565

Gachon University Gil Medical Center, Incheon

22031

US Oncology Investigational Products Center (IPC), Fairfax

22190

Hopital Privé des Cotes d'Armor, Plérin

23007

Hospital Universitario de Jaen, Jaén

23502

US Oncology Investigational Products Center (IPC), Norfolk

24125

Humanitas Gavazzeni, Bergamo

24127

ASST Papa Giovanni XXIII, Bergamo

25030

CHU Jean Minjoz, Besançon

28007

Hospital Beata María Ana, Madrid

Hospital General Universitario Gregorio Marañón, Madrid

28033

MD Anderson Cancer Center, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29605

Prisma Health - Upstate, Greenville

30060

Northwest Georgia Oncology Centers, Marietta

30318

Piedmont Cancer Institute, Atlanta

30341

Georgia Cancer Specialist - Annex, Atlanta

31059

Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse

31096

Oncology Institute Rambam Health Care Campus, Haifa

32701

Investigational Drug Services, AdventHealth Orlando, Altamonte Springs

33076

Institut Bergonié, Bordeaux

33081

Centro di Riferimento Oncologico - IRCCS, Aviano

33305

Chang Gung Memorial Hospital, Linkou, Taoyuan

33705

Florida Cancer Specialist, St. Petersburg

34298

Institut Regional du Cancer de Montpellier, Montpellier

34613

Florida Cancer Specialists, Brooksville

34748

Florida Cancer Specialist, Leesburg

35042

Centre Jean Bernard Service d'Oncologie Médicale, Rennes

35128

Istituto Oncologico Veneto IOV, Padua

37002

Hospital Universitario de Salamanca, Salamanca

37203

Tennessee Oncology, PLLC, Nashville

Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center, Nashville

41013

Hospital Universitario Virgen del Rocio, Seville

41071

Hospital Universitario Virgen Macarena, Seville

41110

University Hospital of Larissa, Larissa

41404

Kyungpook National University Chilgok Hospital, Gyeongsangbuk-do

43210

Stefanie Spielman Comprehensive Breast Center, Columbus

44195

Cleveland Clinic, Cleveland

46009

Instituto Valenciano De Oncologia (IVO), Valencia

46010

Hospital Clínico Universitario de Valencia, Valencia

46236

Marienhospital Bottrop, Bottrop

48013

Hospital de Basurto, Bilbao

48149

Universitatsklinikum Munster, Münster

50586

Hospital Kuala Lumpur, Kuala Lumpur

52621

Sheba Medical Center, Ramat Gan

59000

Centre Oscar Lambret, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona AN

62250

Institut Kanser Negara, Putrajaya

62500

Fakultni Nemocnice Brno, Brno

63141

David C. Pratt Cancer Center, St Louis

64110

Saint Luke's Cancer Institute, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

64460

Hospital Universitario Dr. José Eleuterio González, Monterrey

64710

Centro Medico Zambrano Hellion, San Pedro Garza García

66160

The University of Kansas Hospital, Kansas City

68167

Universitätsklinikum Mannheim, Mannheim

69120

Nationales Centrum für Tumorerkrankungen Heidelberg, Heidelberg

69310

Centre Hospitalier Lyon-Sud, Pierre-Bénite

69373

Centre Leon Berard, Lyon

70809

Hematology Oncology Clinic, Baton Rouge

72076

Universitäts - Frauenklinik, Tübingen

72530

Clinica Integral Internacional de Oncologia S de RL de CV, Puebla City

73657

Chi Mei Hospital, Liouying, Tainan City

75248

Institut Curie, Paris

77550

Centro de Investigacion y Avances Medicos Especializados, Cancún

79106

Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde, Baden-Württemberg

80120

Rocky Mountain Cancer Centers, LLP, Littleton

80131

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli

81377

LMU Klinikum der Universitat München, München

81675

University Hospital rechts der Isar Technical University of Munich, Bayern

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

85028

Irccs Crob, Rionero in Vulture

85224

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

87039

Clinique Francois Chenieux, Limoges

88100

Azienda Ospedaliera Mater Domini, Catanzaro

90017

Los Angeles Hematology Oncology Medical Group, Los Angeles

91054

Universitätsklinik Erlangen, Erlangen

93586

Sarawak General Hospital, Kuching

94143

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

94305

Stanford Cancer Institute, Palo Alto

94800

Institut Gustave Roussy, Villejuif

95045

Humanitas Istituto Clinico Catanese, Catania

97134

Centro de Atención e Investigación Clínica en Oncología, Yucatán

98001

MultiCare Regional Cancer Center - Auburn, Auburn

100044

Peking University People's Hospital, Beijing

119228

National University Hospital, Singapore

130021

The First Hospital of Jilin University, Changchun

130041

The Second Hospital of Jilin University, Jilin Sheng

150081

Harbin Medical University Cancer Hospital, Heilongjiang

169610

National Cancer Centre Singapore, Singapore

200030

Fudan University Shanghai Cancer Center, Shanghai

210029

Jiangsu Province Hospital, Jiangsu

215004

The First Affiliated Hospital of Soochow University, Jiangsu

230001

The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Anhui

250117

Affiliated Cancer Hospital of Shandong First Medical University, Jinan

266071

The Affiliated Hospital Of Qingdao University, Qingdao

308433

Tan Tock Seng Hospital, Singapore

310000

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine, Hangzhou

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang

310022

Zhejiang Cancer Hospital, Hangzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

330009

The Nanchang Third Hospital, Jiangxi

350001

Fujian Medical University Union Hospital, Fuzhou

350015

Fujian Cancer Hospital, Fujian

404100

Chongqing University Cancer Hospital, Chongqing

410008

Xiangya Hospital Central South University, Changsha

430079

Hubei Cancer Hospital, Wuhan

450003

Henan Cancer Hospital, Zhengzhou

453000

Tianjin Medical University Cancer Institute & Hospital, Tianjin

510060

Sun Yat-Sen University Cancer Center, Guangdong

510080

Guangdong Provincial People's Hospital, Guangzhou

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

510120

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

610041

West China Hospital Sichuan University, Chengdu

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

750004

General Hospital of Ningxia Medical University, Ningxia Hui

999999

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

1040045

National Cancer Center Hospital, Chūōku

1317000

Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria, São Paulo

2520612

Oncocentro APYS, Viña del Mar

4941492

Rabin Medical Center, Petah Tikva

7550000

Centro del Cancer UC, Region Metropolitana

8330032

Centro de Oncología de Precisión (COP), Santiago Region

9103102

Shaare Zedek Medical Center, Jerusalem

50070550

IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Pernambuco

80810050

CIONC-Centro Integrado de Oncologia de Curitiba, Paraana

90610001

Hospital São Lucas da PUCRS, Porto Alegre

06510

Yale-New Haven Hospital-Yale Cancer Center, New Haven

08816

Astera Cancer Care, East Brunswick

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

B7600

Instituto de Investigaciones Clinicas de Mar del Plata, Buenos Aires

1426ANZ

Instituto Alexander Fleming, C.a.b.a.

06020

University Hospital Innsbruck, Innsbruck

A-5020

Universitätsklinik für Innere Medizin 3 der PMU, Salzburg

60430-230

Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará, Fortaleza

74605-070

Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias, Goiânia

98700-000

Oncosite - Centro de Pesquisa Clinica e Oncologia, Ijuí

88301-220

Catarina Pesquisa Clinica, Itajaí

30360-680

Oncoclinicas do Brasil Servicos Medicos AS, Minas Gerais

59062-000

Liga Norte-Rio-Grandense Contra o Câncer, Natal

81.520-060

Hospital Erasto Gaertner, Paraná

90020-090

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

90035-903

Hospital de Clínicas de Porto Alegre - HCPA, Porto Alegre

90110-270

HGB - Hospital Giovanni Battista/Mãe de Deus Center, Porto Alegre

22775-001

Instituto Americas, Rio de Janeiro

90430-090

Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO, Rio Grande

96020-080

Unidade de PesquisasClinicas em Oncologia - UPCO, Rio Grande

99010-090

Instituto do Câncer - Hospital São Vicente de Paulo, Rio Grande

09060-650

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

01236-030

Instituto Hemomed Oncologia e Hematologia, São Paulo

V1Y 5L3

BC Cancer - Kelowna, Kelowna

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

G1S 4L8

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

M3M 0B2

Humber River Hospital, Toronto

V8R 6V5

BC Cancer-Victoria, Victoria

Unknown

Centro de Investigacion Clinica Bradford Hill, Recoleta

James Lind Centro de Investigacion del Cancer, Temuco

Centre Henri Becquerel, Rouen

University Hospital of Heraklion, Heraklion

Prince of Wales Hospital, New Territories

Hadassah Medical Center, Jerusalem

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

Fukushima Medical University Hospital, Fukushima

Centro Clinico Academico - Hospital de Braga, Braga

656 53

Masaryk Memorial Cancer Institute, Brno

779 00

University Hospital Olomouc, Olomouc

532 01

Multiscan s.r.o, Pardubice

760 01

Krajska nemocnice Tomase Bati Zlin, Zlín

44 805

Ico René Gauducheau, Loire Atlantique

07548

SRH Wald-Klinikum Gera GmbH, Gera

D-30625

Medizinische Hochschule Hannover, Hanover

124 62

Attikon Hospital, Athens

26 500

University Hospital of Patras, Pátrai

546 22

Bioclinic of Thessaloniki, Thessaloniki

546 45

Euromedica General Clinic of Thessaloniki, Thessaloniki

464-8681

Aichi Cancer Center Hospital, Aichi

980-8574

Tohoku University Hospital, Aoba-ku

113-8431

Juntendo University Hospital, Bunkyō City

260-8717

Chiba Cancer Center, Chiba

541-8567

Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Chūōku

791-0280

National Hospital Organization Shikoku Cancer Center, Ehime

892-0833

Social Medical Corporation Hakuaikai Sagara Hospital, Kagoshima

259-1193

Tokai University Hospital, Kanagawa

277-8577

National Cancer Center Hospital East, Kashiwa

362-0806

Saitama Cancer Center, Kitaadachi-gun

135-8550

Cancer Institute Hospital of JFCR, Kōtoku

860-8556

Kumamoto University Hospital, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

811-1395

National Hospital Organization Kyushu Cancer Center, Minamiku

466-8560

Nagoya University Hospital, Nagoya

730-8518

Hiroshima City Hiroshima Citizens Hospital, Nakaku

663-8501

Hyogo Medical University Hospital, Nishinomiya-shi

700-8558

Okayama University Hospital, Okayama

373-8550

Gunma Prefectural Cancer Center, Ōta-ku

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

162-8655

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku

142-8555

Showa University Hospital, Tokyo

241-8515

Kanagawa Cancer Center, Yokohama

04700

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

80-219

Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku, Gdansk

31-826

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

90-302

Instytut MSF Sp. z o.o., Lodz

01-748

LUX MED Onkologia Sp. Zo.o., Warsaw

02-781

Maria Sklodowska - Curie Institute of Oncology, Warsaw

4835-044

Hospital da Senhora da Oliveira Guimaraes, Guimarães

1153-302

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

1400-038

Fundacao Champalimaud, Lisbon

1649-035

Centro Hospitalar Lisboa Norte, EPE, Lisbon

4464-513

Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano, Matosinhos Municipality

0081

Wilgers Oncology Centre, Gauteng

06351

Samsung Medical Center, Gangnam-Gu

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08028

Hospital Universitari Dexeus, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

EC1A 7BE

Barts Cancer Institute, London

NW1 2PG

University College London Hospitals, London

SW10 9NH

The Royal Marsden NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY