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 (ASCENT-07)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Stage IV Breast Cancer; Locally Advanced or Unresectable Metastatic Breast Cancer
• Intervention / Treatment: Drug: Sacituzumab Govitecan-hziy; Drug: Paclitaxel; Drug: Capecitabine; Drug: Nab-paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 654
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Hospital Britanico de Buenos Aires
  • Buenos Aires, Argentina, B7600
    • Instituto de Investigaciones clinicas de Mar del Plata
  • C.a.b.a., Argentina, 1426ANZ
    • Instituto Alexander Fleming
  • CABA, Argentina, 1118
    • Hospital Aleman
  • Córdoba, Argentina, 5800
    • Centro Privado de RMI Rio Cuarto S.A.
  • Rosario, Argentina, 2000
    • Instituto de Oncología de Rosario
  • San Juan, Argentina, 5400
    • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
• Australia
  • ME
    • Queensland, ME, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare North Shore (Oncology)
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Centre Wesley
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Icon Cancer Centre Hobart
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Health
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital (Western Health)
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Breast Cancer Research Centre - WA
• Austria
  • Innsbruck, Austria, 06020
    • University Hospital Innsbruck
  • Salzburg, Austria, A-5020
    • Universitätsklinik für Innere Medizin 3 der PMU
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
  • Wels, Austria, 4710
    • Klinikum Wels-Grieskirchen
• Belgium
  • Antwerp, Belgium, 2610
    • GZA Ziekenhuizen - campus Sint-Augustinus
  • Brasschaat, Belgium, 2930
    • AZ KLINA
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuis Leuven
  • Namur, Belgium, 5000
    • CHU UCL Namur-Site STE. Elisabeth
• Brazil
  • Fortaleza, Brazil, 60430-230
    • Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
  • Goiânia, Brazil, 74605-070
    • Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
  • Ijuí, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • Itajaí, Brazil, 88301-220
    • Catarina Pesquisa Clinica
  • Minas Gerais, Brazil, 30360-680
    • Oncoclinicas do Brasil Servicos Medicos As
  • Natal, Brazil, 59062-000
    • Liga Norte-Rio-Grandense Contra O Câncer
  • Paraana, Brazil, 80810050
    • CIONC-Centro Integrado de Oncologia de Curitiba
  • Paraná, Brazil, 81.520-060
    • Hospital Erasto Gaertner
  • Pernambuco, Brazil, 50070550
    • IMIP - Instituto de Medicina Integral Professor Fernando Figueira
  • Porto Alegre, Brazil, 90035-903
    • Hospital de Clinicas de Porto Alegre - HCPA
  • Porto Alegre, Brazil, 90020-090
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90110-270
    • HGB - Hospital Giovanni Battista/Mãe de Deus Center
  • Porto Alegre, Brazil, 90610001
    • Hospital Sao Lucas Da Pucrs
  • Rio Grande, Brazil, 90430-090
    • Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO
  • Rio Grande, Brazil, 96020-080
    • Unidade de PesquisasClinicas em Oncologia - UPCO
  • Rio Grande, Brazil, 99010-090
    • Instituto do Câncer - Hospital São Vicente de Paulo
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto Americas
  • Santo André, Brazil, 09060-650
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • São Paulo, Brazil, 01236-030
    • Instituto Hemomed Oncologia e Hematologia
  • São Paulo, Brazil, 1317000
    • Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
• Canada
  • Kelowna, Canada, V1Y 5L3
    • BC Cancer - Kelowna
  • Ottawa, Canada, K1H 8L6
    • The Ottawa Hospital Cancer Centre
  • Québec, Canada, G1S 4L8
    • CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
  • Toronto, Canada, M3M 0B2
    • Humber River Hospital
  • Victoria, Canada, V8R 6V5
    • BC Cancer-Victoria
• Chile
  • Recoleta, Chile
    • Centro de Investigacion Clinica Bradford Hill
  • Region Metropolitana, Chile, 7550000
    • Centro Del Cancer UC
  • Santiago Region, Chile, 8330032
    • Centro de Oncología de Precisión (COP)
  • Temuco, Chile
    • James Lind Centro de Investigacion del Cancer
  • Viña del Mar, Chile, 2520612
    • Oncocentro Apys
• China
  • Anhui, China, 230001
    • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410008
    • Xiangya Hospital Central South University
  • Chengdu, China, 610041
    • West China Hospital Sichuan University
  • Chongqing, China, 404100
    • Chongqing University Cancer Hospital
  • Fujian, China, 350015
    • Fujian Cancer Hospital
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital
  • Guangdong, China, 510060
    • Sun Yat-sen University Cancer Center
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510080
    • The First Affiliated Hospital of Sun Yat-sen University
  • Guangzhou, China, 510120
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310000
    • Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
  • Heilongjiang, China, 150081
    • Harbin Medical University Cancer Hospital
  • Jiangsu, China, 210029
    • Jiangsu Province Hospital
  • Jiangsu, China, 215004
    • The First Affiliated Hospital of Soochow University
  • Jiangxi, China, 330009
    • The Nanchang Third Hospital
  • Jilin Sheng, China, 130041
    • The Second Hospital of Jilin University
  • Jinan, China, 250117
    • Affiliated Cancer Hospital of Shandong First Medical University
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Ningxia Hui, China, 750004
    • General Hospital of Ningxia Medical University
  • Qingdao, China, 266071
    • The Affiliated Hospital of Qingdao University
  • Shanghai, China, 200030
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 453000
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Zhejiang, China, 310009
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Zhengzhou, China, 450003
    • Henan Cancer Hospital
• Czechia
  • Brno, Czechia, 62500
    • Fakultni nemocnice Brno
  • Brno, Czechia, 656 53
    • Masaryk Memorial Cancer Institute
  • Olomouc, Czechia, 779 00
    • University Hospital Olomouc
  • Pardubice, Czechia, 532 01
    • Multiscan s.r.o
  • Prague, Czechia, 12808
    • Charles General University Hospital, Prague
  • Prague, Czechia, 14059
    • Fakultni nemocnice v Motole
  • Zlín, Czechia, 760 01
    • Krajska nemocnice Tomase Bati Zlin
• France
  • Besançon, France, 25030
    • Chu Jean Minjoz
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Dijon, France, 21000
    • Centre Georges François Leclerc
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Limoges, France, 87039
    • Clinique Francois Chenieux
  • Loire Atlantique, France, 44 805
    • Ico Rene Gauducheau
  • Lyon, France, 69373
    • Centre Leon Berard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Montpellier, France, 34298
    • INSTITUT REGIONAL DU CANCER DE MONTPELLIER
  • Paris, France, 75248
    • Institut Curie
  • Pierre-Bénite, France, 69310
    • Centre Hospitalier Lyon-Sud
  • Plérin, France, 22190
    • Hôpital Privé Des Côtes d'Armor
  • Rennes, France, 35042
    • Centre Jean Bernard Service d'Oncologie Médicale
  • Rouen, France
    • Centre Henri Becquerel
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer de Toulouse Oncopole
  • Villejuif, France, 94800
    • Institut Gustave Roussy
• Germany
  • Baden-Württemberg, Germany, 79106
    • Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde
  • Bayern, Germany, 81675
    • University Hospital rechts der Isar Technical University of Munich
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Berlin, Germany, 10967
    • Vivantes Klinikum am Urban
  • Bottrop, Germany, 46236
    • Marienhospital Bottrop
  • Erlangen, Germany, 91054
    • Universitätsklinik Erlangen
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Hanover, Germany, D-30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Nationales Centrum für Tumorerkrankungen Heidelberg
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim
  • München, Germany, 81377
    • LMU Klinikum der Universität München
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Tübingen, Germany, 72076
    • Universitäts - Frauenklinik
• Greece
  • Athens, Greece, 11528
    • Alexandra General Hospital
  • Athens, Greece, 124 62
    • Attikon Hospital
  • Heraklion, Greece
    • University Hospital of Heraklion
  • Larissa, Greece, 41110
    • University Hospital Of Larissa
  • Pátrai, Greece, 26 500
    • University Hospital of Patras
  • Thessaloniki, Greece, 546 45
    • EUROMEDICA General Clinic of Thessaloniki
  • Thessaloniki, Greece, 546 22
    • Bioclinic of Thessaloniki
• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong Integrated Oncology Centre
  • New Territories, Hong Kong
    • Prince Of Wales Hospital
  • Pok Fu Lam, Hong Kong
    • Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kecskemét, Hungary, 6000
    • Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• Israel
  • Haifa, Israel, 31096
    • Oncology Institute Rambam Health Care Campus
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Ancona AN, Italy, 60126
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico - IRCCS
  • Bergamo, Italy, 24127
    • Asst Papa Giovanni XXIII
  • Bergamo, Italy, 24125
    • Humanitas Gavazzeni
  • Bologna, Italy
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
  • Catania, Italy, 95045
    • Humanitas Istituto Clinico Catanese
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliera Mater Domini
  • Genova GE, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia
  • Milan, Italy, 20132
    • Fondazione IRCCS San Raffaele del Monte Tabor
  • Monza, Italy, 20090
    • Azienda Ospedaliera San Gerardo
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
  • Padua, Italy, 35128
    • Istituto Oncologico Veneto IOV
  • Rionero in Vulture, Italy, 85028
    • Irccs Crob
  • Roma, Italy, 168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Roma, Italy, 161
    • Azienda Ospedaliero-Universitaria Policlinico Umberto I
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Aoba-ku, Japan, 980-8574
    • Tohoku University Hospital
  • Bunkyō City, Japan, 113-8431
    • Juntendo University Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Chūōku, Japan, 541-8567
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Chūōku, Japan, 1040045
    • National Cancer Center Hospital
  • Ehime, Japan, 791-0280
    • National Hospital Organization Shikoku Cancer Center
  • Fukushima, Japan
    • Fukushima Medical University Hospital
  • Kagoshima, Japan, 892-0833
    • Social Medical Corporation Hakuaikai Sagara Hospital
  • Kanagawa, Japan, 259-1193
    • Tokai University Hospital
  • Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Kitaadachi-gun, Japan, 362-0806
    • Saitama Cancer Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Kōtoku, Japan, 135-8550
    • Cancer Institute Hospital of Jfcr
  • Minamiku, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Nagoya, Japan, 466-8560
    • Nagoya University Hospital
  • Nakaku, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital
  • Nishinomiya-shi, Japan, 663-8501
    • Hyogo Medical University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Sapporo, Japan, 003-0804
    • National Hospital Organization Hokkaido Cancer Center
  • Shinjuku-ku, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine
  • Tokyo, Japan, 142-8555
    • Showa University Hospital
  • Yokohama, Japan, 241-8515
    • Kanagawa Cancer Center
  • Ōta-ku, Japan, 373-8550
    • Gunma Prefectural Cancer Center
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Putrajaya, Malaysia, 62250
    • Institut Kanser Negara
• Mexico
  • Cancún, Mexico, 77550
    • Centro de Investigacion y Avances Medicos Especializados
  • Mexico City, Mexico, 04700
    • COI Centro Oncologico Internacional S.A.P.I. de C.V.
  • Monterrey, Mexico, 64460
    • Hospital Universitario Dr. Jose Eleuterio González
  • México, Mexico, 4980
    • FUCAM
  • Puebla City, Mexico, 72530
    • Clínica Integral Internacional de Oncología S de RL de CV
  • San Pedro Garza García, Mexico, 64710
    • Centro Medico Zambrano Hellion
  • Yucatán, Mexico, 97134
    • Centro de Atención e Investigación Clínica en Oncología
• Poland
  • Gdansk, Poland, 80-219
    • Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku
  • Krakow, Poland, 31-826
    • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
  • Lodz, Poland, 90-302
    • Instytut MSF Sp. z o.o.
  • Lublin, Poland, 19713
    • Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie
  • Warsaw, Poland, 01-748
    • LUX MED Onkologia Sp. Zo.o.
  • Warsaw, Poland, 02-781
    • Maria Sklodowska - Curie Institute of Oncology
• Portugal
  • Braga, Portugal
    • Centro Clinico Academico - Hospital de Braga
  • Guimarães, Portugal, 4835-044
    • Hospital Da Senhora Da Oliveira Guimarăes
  • Lisbon, Portugal, 1400-038
    • Fundacao Champalimaud
  • Lisbon, Portugal, 1153-302
    • Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, EPE
  • Matosinhos Municipality, Portugal, 4464-513
    • Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 119228
    • National University Hospital
• South Africa
  • Gauteng, South Africa, 0081
    • Wilgers Oncology Centre
  • Johannesburg, South Africa, 2192
    • Wits Clinical Research
  • Johannesburg, South Africa, 2196
    • The Medical Oncology Centre of Rosebank
  • Kraaifontein, South Africa, 7570
    • Cape Town Oncology Trials
• South Korea
  • Gangnam-Gu, South Korea, 06351
    • Samsung Medical Center
  • Goyang-si Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Gyeongsangbuk-do, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus
  • Barcelona, Spain, 8035
    • Hospital Universitari Vall d'Hebron
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Elche, Spain, 3203
    • Hospital General Universitario de Elche
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaén
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Madrid, Spain, 28007
    • Hospital Beata Maria Ana
  • Salamanca, Spain, 37002
    • Hospital Universitario de Salamanca
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico Universitario de Santiago de Compostela - CHUS
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41071
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncología (IVO)
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 235
    • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
  • Tainan City, Taiwan, 73657
    • Chi Mei Hospital, Liouying
  • Tainan City, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taipei, Taiwan, 999999
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals
  • London, United Kingdom, EC1A 7BE
    • Barts Cancer Institute
  • London, United Kingdom, SW10 9NH
    • The Royal Marsden NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  • California
    • Los Angeles, California, United States, 90017
      • Los Angeles Hematology Oncology Medical Group
    • Palo Alto, California, United States, 94305
      • Stanford Cancer Institute
    • San Francisco, California, United States, 94143
      • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Centers, LLP
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital-Yale Cancer Center
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Investigational Drug Services, AdventHealth Orlando
    • Brooksville, Florida, United States, 34613
      • Florida Cancer Specialists
    • Leesburg, Florida, United States, 34748
      • Florida Cancer Specialist
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialist
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Piedmont Cancer Institute
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialist - Annex
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology Oncology Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64110
      • Saint Luke's Cancer Institute
    • St Louis, Missouri, United States, 63141
      • David C. Pratt Cancer Center
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Stefanie Spielman Comprehensive Breast Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens of UPMC
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health - Upstate
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • US Oncology Investigational Products Center (IPC)
    • Norfolk, Virginia, United States, 23502
      • US Oncology Investigational Products Center (IPC)
  • Washington
    • Auburn, Washington, United States, 98001
      • MultiCare Regional Cancer Center - Auburn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Able to understand and give written informed consent.
• Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
• Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.
• Documented evidence of HER2- status.
• Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
• Candidate for the first chemotherapy in the locally advanced or metastatic setting.
• Eligible for capecitabine, nab-paclitaxel, or paclitaxel.

• Individuals must have at least one of the following:

  • Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.

    • Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
  • Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.
  • Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
• Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
• Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
• Demonstrates adequate organ function.
• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

• Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
• Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

• Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.

  • Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
• Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
• Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
• Have an active second malignancy.
• Have an active serious infection requiring antibiotics.
• Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
• Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy (SG); Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132; Trodelvy™
Active Comparator: Treatment of Physician's Choice (TPC); Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.; nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.; capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.	Drug: Paclitaxel; Administered intravenously; Other Names: Taxol®; Drug: Capecitabine; Administered orally; Other Names: Xeloda®; Drug: Nab-paclitaxel; Administered intravenously; Other Names: Abraxane®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.	Up to approximately 29 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization until the date of death from any cause.	Until death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.	Until progression, up to approximately 60 months
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16	The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.	Baseline, Week 16
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores	Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Up to approximately 60 months
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.	Until progression or death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.	Up to approximately 60 months
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1	DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).	Until progression or death, up to approximately 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		First dose date up to 30 days post last dose, up to approximately 60 months
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities		First dose date up to 30 days post last dose, up to approximately 60 months

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Tarantino P, Tolaney SM, Curigliano G. Trastuzumab deruxtecan (T-DXd) in HER2-low metastatic breast cancer treatment. Ann Oncol. 2023 Oct;34(10):949-950. doi: 10.1016/j.annonc.2023.07.003. Epub 2023 Jul 26. No abstract available.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Albumins; Capecitabine; Albumin-Bound Paclitaxel; Paclitaxel; 130-nm albumin-bound paclitaxel; sacituzumab govitecan
• Other Study ID Numbers: GS-US-598-6168; 2022-502593-17-00 (Other Identifier: European Medicines Agency); jRCT2061230032 (Other Identifier: Japan Registry of Clinical Trials); DOH-27-082023-6901 (Other Identifier: South African National Clinical Trials Registry); MOH_2023-07-17_012821 (Other Identifier: Israel Clinical Research Site); CTR20233370 (Registry Identifier: China: Drug Clinical Trial Registration and Information Disclosure Platform)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No