A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Early Breast Cancer
• Intervention / Treatment: Drug: Giredestrant; Drug: LHRH Agonist; Drug: Physician's Choice of Endocrine Therapy

• Study Type: Interventional
• Enrollment (Actual): 4170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Bahía Blanca, Argentina, 8000
    • Hospital Italiano Regional Del Sur
  • Buenos Aires, Argentina, B7600FZN
    • Instituto de Investigaciones Clinicas-Mar del Plata
  • Buenos Aires, Argentina, C1012
    • Instituto de Investigaciones Metabolicas (IDIM)
  • Caba, Argentina, C1426AGE
    • Centro Oncológico Korben
  • Cipolletti, Argentina, 8324
    • Fundacion Medica de Rio Negro Y Nuequen
  • Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
    • Consultorios Médicos Dr. Doreski
  • Córdoba, Argentina, 5000
    • Sanatorio Allende Servicio Nefrología
  • Córdoba, Argentina, X5008HIS
    • Centro Medico Privado CEMAIC
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (Cori)
  • Mar del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Medicas Mar Del Plata
  • Mar del Plata, Argentina, B7603CBM
    • Hospital Privado de la Comunidad
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino SA
  • Provincia de Tucumán, Argentina, T4000
    • Exelsus clinica Oncologica
  • Rosario, Argentina, 2000
    • Instituto Medico de La Fundacion Estudios Clinicos
  • Rosario, Argentina, S2000DSV
    • Sanatorio Parque de Rosario
  • Rosario, Argentina, S2000DBS
    • Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
  • Rosario, Argentina, S2013KZE
    • Instituto de Oncología de Rosario
  • San Juan, Argentina, J5402DIL
    • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
  • San Nicolás, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
  • San Salvador de Jujuy, Argentina
    • Fundacion Ars Medica
  • Viedma, Argentina, R8500ACE
    • Centro de Investigación Clínica ? Clínica Viedma
  • Ciudad Autónoma de BuenosAires
    • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
      • Centro de Investigaciones Médicas y Desarrollo LC S.R.L
  • Río Negro Province
    • Bariloche, Río Negro Province, Argentina, 8400
      • Fundacion Intectus
• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Border Medical Oncology Research Unit
    • Campbelltown, New South Wales, Australia, 2560
      • Campbelltown Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Northmead, New South Wales, Australia, 2152
      • Westmead Hospital
    • Port Macquarie, New South Wales, Australia, 2444
      • North Coast Cancer Institute - Port Macquarie
    • Wollstonecraft, New South Wales, Australia, 2065
      • Mater Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Wesley Medical Centre
    • Brisbane, Queensland, Australia, 4101
      • Mater Cancer Care Centre
    • Cairns, Queensland, Australia, 4870
      • Cairns Hospital
    • Townsville, Queensland, Australia, 4810
      • Townsville Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5000
      • St Andrews Medical Centre
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • ICON Cancer Care Hobart
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Bendigo Hospital
    • Epping, Victoria, Australia, 3076
      • Northern Hospital
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital
    • Ringwood East, Victoria, Australia, 3135
      • Maroondah Hospital
    • Shepparton, Victoria, Australia, 3630
      • Goulburn Valley Health
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
    • Warrnambool, Victoria, Australia, 3280
      • South West Healthcare
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Oncology & Haematology
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Austria
  • Graz, Austria, 8036
    • LKH-Universitätsklinikum Klinikum Graz
  • Innsbruck, Austria, 6020
    • Medizinische Universitat Innsbruck
  • Rankweil, Austria, 6830
    • LKH Rankweil, Interne E
  • Salzburg, Austria, 5020
    • Universitätsklinikum Salzburg
  • Sankt Pölten, Austria, 3100
    • Universitätsklinikum St. Pölten
  • Sankt Veit im Pongau, Austria, 9300
    • A.ö. Krankenhaus der Barmherzigen Brüder
  • Steyr, Austria, 4400
    • Oö. Gesundheits- und Spitals-AG/LKH Steyr
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien Medical University of Vienna
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
• Belgium
  • Belgium, Belgium, 1000
    • Institute Jules Bordet
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi asbl
  • Libramont, Belgium, 6800
    • CH de l'Ardenne (Libramont)
  • Liège, Belgium, 4000
    • CHU Sart Tilman
  • Liège, Belgium, 4000
    • Centre Hospitalier Chretien MontLegia
  • Liège, Belgium, 4000
    • CHR de la Citadelle, Pharmacie
  • Namur, Belgium, 5000
    • Clinique Sainte-Elisabeth
  • Namur, Belgium, 5530
    • Cliniques Universitaires UCL de Mont-Godinne
  • Wilrijk, Belgium, 2610
    • GZA Ziekenhuizen Antwerpen campus Sint-Augustinus
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Clinical Center Banja Luka
  • Mostar, Bosnia and Herzegovina, 88000
    • Clinical hospital Mostar
  • Tuzla, Bosnia and Herzegovina, 75000
    • University Clinical Center Tuzla
• Brazil
  • Rio de Janeiro, Brazil, 20560-120
    • Instituto Nacional de Cancer - INCa
  • São Paulo, Brazil, 04543-000
    • Onco Star Sp Oncologia Ltda
  • São Paulo, Brazil, 03102-002
    • Instituto Brasileiro De Controle Do Câncer - IBCC
  • São Paulo, Brazil, 0317-0001
    • Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda
  • São Paulo, Brazil, 01246-000
    • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
  • Espírito Santo
    • Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-014
      • Centro de Pesquisas Clínicas Em Oncologia - CPCO
  • Estado de Bahia
    • Salvador, Bahia, Estado de Bahia, Brazil, 40170-380
      • Nucleo de Oncologia da Bahia - NOB
    • Salvador/BA, Estado de Bahia, Brazil, 41820-021
      • Centro de Oncologia da Bahia
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-070
      • Hospital Araujo Jorge
  • Mato Grosso do Sul
    • Pôrto Alegre, Mato Grosso do Sul, Brazil, 90110-270
      • Hospital Mae de Deus
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-090
      • Cenantron - Centro Avancado de Tratamento Oncologico
    • Belo Horizonte, Minas Gerais, Brazil, 30360-680
      • Oncoclinicas do Brasil Servicos Medicos As
  • Pará
    • Porto Alegre, Pará, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre HCPA PPDS
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50040-000
      • Hospital do Cancer de Pernambuco - HCP
  • Rio Grande do Sul
    • Caixas Do Sul, Rio Grande do Sul, Brazil, 95070-560
      • Universidade de Caxias do Sul - Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • ONCOSITE Centro de Pesquisa Clínica Em Oncologia
    • Lajeado, Rio Grande do Sul, Brazil, 95900-000
      • Hospital Bruno Born
    • Passo Fundo, Rio Grande do Sul, Brazil, 99001-970
      • Hospital São Vicente de Paulo X
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Clinica de Neoplasias Litoral
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • *X*Fundação Pio XII Hospital de Câncer de Barretos
    • Jaú, São Paulo, Brazil, 17210-120
      • Hospital Amaral Carvalho
    • Piracicaba, São Paulo, Brazil, 13419-160
      • Instituto de Oncologia Clínica de Piracicaba
    • Santo André, São Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC - FMABC
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Complex Oncology Center Burgas
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment Uni Hospital
• Canada
  • Québec, Canada, G1S 4L8
    • CHU de Quebec-Universite Laval
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Arthur J.E. Child Comprehensive Cancer Center-Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4R2
      • British Columbia Cancer Agency
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • The Moncton Hospital
  • Ontario
    • Sault Ste. Marie, Ontario, Canada, P6B 0A8
      • Sault Area Hospital
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay Lac Saint Jean
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles Le Moyne
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center
    • Montreal, Quebec, Canada, H2X 3E4
      • CHUM
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B Davis Jewish General Hospital
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS-de-l?Est-de-l?Île-de-Montréal
    • Saint-Jérôme, Quebec, Canada, H7Z 5T3
      • St-Jérome Medical Research, Inc.
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
• Chile
  • La Serena, Chile, 1700000
    • IC La Serena Research SpA
  • Port Montt, Chile, 5480000
    • Patagonia Research
  • Providencia, Chile, 7500000
    • Centro de Estudios Clinicos SAGA Spa
  • Rancagua, Chile
    • Servicios Médicos URUMED SpA
  • Santiago, Chile, 8320000
    • Meditek Ltda
  • Santiago, Chile
    • Icegclinic
  • Santiago, Chile
    • Medwal
  • Santiago, Chile, 8330336
    • Centro de Estudios Clinicos E Investigaciones Medicas
  • Santiago, Chile, 7510035
    • Oncovida - Santiago
  • Talca, Chile, 3460000
    • Clinica Universidad Catolica del Maule
  • Temuco, Chile, 4810469
    • Clinica Alemana de Temuco
  • Viña del Mar, Chile, 2520598
    • Oncocentro Apys
  • Viña del Mar, Chile, 2540333
    • Centro de Investigaciones Clinicas Viña del Mar
  • Región-MetropolitanadeSantiago
    • Providencia, Región-MetropolitanadeSantiago, Chile, 7500000
      • Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805
• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Changchun, China, 132013
    • Jilin Cancer Hospital
  • Dalian, China, 116027
    • The Second Affiliated Hospital of Dalian Medical University
  • Fuzhou, China, 350014
    • Fujian Provincial Cancer Hospital
  • Guangzhou, China, 510060
    • Sun Yat-sen University Cancer Center
  • Guangzhou, China, 510010
    • Guangdong Provincial Maternity and Child Care Cent
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Harbin, China, 150040
    • Harbin medical university cancer hospital
  • Hefei, China, 230001
    • Anhui Province Cancer Hospital
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Linyi, China, 273316
    • Linyishi Cancer Hospital
  • Nanchang, China, 330009
    • The Third Hospital of Nanchang
  • Nanning, China, 530021
    • Guangxi Cancer Hospital of Guangxi Medical University
  • Neijiang, China, 641000
    • The Second People's Hospital of Neijiang
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110004
    • Shengjing Hospital Of China Medical University
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute & Hospital
  • Wenzhou, China, 325000
    • Wenzhou Medical College - The First Affiliated Hospital GCP
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Wuhan, China, 430023
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Xi'an, China, 710032
    • Air Force Military Medical University Xijing Hospital
  • Xiamen, China, 361003
    • The first affiliated hospital of xiamen university
  • Xuzhou, China
    • The Affiliated Hospital of Xuzhou Medical University
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
• Colombia
  • Cali, Colombia, 760042
    • Hemato Oncólogos S.A
  • Floridablanca, Colombia
    • FOSCAL
  • Pereira, Colombia, 660003
    • Oncólogos Del Occidente SA
  • Valledupar, Colombia, 200001
    • Sociedad de Oncología y hematología del Cesar Ltda
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia, 230001
      • Oncomedica S.A.
• Costa Rica
  • Moravia, Costa Rica, 11401
    • Consultorio Oncologico-Hospital Metropolitano Linc
  • San José, Costa Rica, 10903
    • Metropolitano Research Institute Lindora
  • San José, Costa Rica
    • Centro de Cáncer y Hematología
  • San José, Costa Rica
    • Instituto de Investigación en Ciencias Médicas S.A.
  • Alajuela Province
    • San José, Alajuela Province, Costa Rica, 20303
      • Policlínico San Bosco
• Croatia
  • Pula, Croatia, 52100
    • General Hospital Pula
  • Split, Croatia, 21000
    • University Hospital of Split
  • Varaždin, Croatia, 42000
    • General Hospital Varazdin
  • Zagreb, Croatia, 10000
    • Klinicki bolnicki centar Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sestre Milosrdnice
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sestre Milosrdnice - Medical Oncology Department
• Czechia
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 140 59
    • Fakultni Thomayerova nemocnice
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
  • Olomouc Region
    • Olomouc, Olomouc Region, Czechia, 779 00
      • Fakultni nemocnice Olomouc
• Egypt
  • Al Mansurah, Egypt, 35516
    • Mansoura University Hospital
  • Alexandria, Egypt
    • Medical Technology Center for Research and Services
  • Alexandria, Egypt
    • Alexandria Uni
  • Cairo, Egypt, 11566
    • Ain Shams University Hospital
  • Cairo, Egypt, 11562
    • Kasr Al Ainy School of Medicine-Cairo University
  • Fostat, Egypt, 11632
    • Gustave Roussy International Egypt Hospital
  • Markaz Sohag, Egypt, 82511
    • Sohag Oncology Center
• Finland
  • Helsinki, Finland, 00290
    • Helsingin Yliopistollinen Keskussairaala
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tays Central Hospital
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Turku University Hospital
• France
  • Argenteuil, France, 95100
    • Hopital d'Argenteuil
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
  • Grenoble, France, 38000
    • Institut Daniel Hollard
  • La Roche-sur-Yon, France, 85925
    • Centre Hospitalier Départemental de Vendée
  • Le Mans, France, 72015
    • Centre de cancérologie de la Sarthe - Aile B
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Marseille, France, 13273
    • Hopital Prive Clairval
  • Nantes, France, 44277
    • Hôpital Privé du Confluent
  • Paris, France, 75248
    • Institut Curie
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75013
    • Hôpital Universitaire Pitié Salpêtrière
  • Plérin, France, 22190
    • Hopital privé des Côtes Armor
  • Rennes, France, 35042
    • EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint-Cloud, France, 92210
    • Curie Saint Cloud
  • Calvados
    • Caen, Calvados, France, 14000
      • Centre Francois Baclesse
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87042
      • CHU Limoges - Dupuytren 1
  • Hérault
    • Montpellier, Hérault, France, 34070
      • Clinique Clémentville
• Georgia
  • Batumi, Georgia, 6000
    • High Technology Hospital MedCenter Ltd
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla
  • Tbilisi, Georgia, 0112
    • Ltd Israel-Georgia Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 0144
    • LTD Health House
  • Tbilisi, Georgia, 0112
    • Acad. F. Todua Medical Center
  • Tbilisi, Georgia, 0159
    • Institute of Clinical Oncology Ltd
  • Tbilisi, Georgia, 0160
    • LTD TIM, Tbilisi Institute of Medicine
  • Tbilisi, Georgia, 179
    • S Khechinashvili University Clinic Ltd
• Germany
  • Augsburg, Germany, 86150
    • Hämatologisch/onkologische Gemeinschaftspraxis
  • Berlin, Germany, 13581
    • Ambulantes Tumorzentrum Spandau
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Essen, Germany, 45136
    • KEM/Evang. Kliniken Essen Mitte gGmbH
  • Georgsmarienhütte, Germany, 49124
    • Franziskus-Hospital Harderberg
  • Hamburg, Germany, 20357
    • Mammazentrum Hamburg am Krankenhaus Jerusalem
  • Mainz, Germany, 55131
    • Universitätsklinikum Mainz
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH Universitätsklinikum
  • Mönchengladbach, Germany, 41061
    • Praxis fuer gynaekologische onkologie Prof. Dr. me
  • Ravensburg, Germany, 88212
    • Hämatologie und Onkologie Ravensburg / Wangen
  • Schweinfurt, Germany, 97422
    • Leopoldina Krankenhaus Schweinfurt
  • Velbert, Germany, 42551
    • Praxis fur Haematologie und Internistische Onkologie
  • Baden-Wurttemberg
    • Karlsruhe, Baden-Wurttemberg, Germany, 76135
      • Vincentius-Diakonissen-Kliniken gAG
• Greece
  • Athens, Greece, 11527
    • Sotiria Chest Hospital of Athens
  • Athens, Greece, 115 26
    • Henry Dunant Hospital
  • Athens, Greece, 145 64
    • General Oncology Hospital Kifissias "Oi Agioi Anargyroi"
  • Athens, Greece, 115 28
    • Aretaieio Hospital of Athens
  • Athens, Greece, 115 27
    • University of Athens, Hematological Clinic; First Department of Propaedeutic Medicine
  • Chaïdári, Greece, 124 62
    • Attikon University General Hospital
  • Cholargós, Greece, 155 62
    • Metropolitan General Hospital
  • Cholargós, Greece, 155 62
    • Metropolitan General Hospital, A' Oncology Clinic
  • Faliro, Greece, 185 47
    • Metropolitan Hospital First Oncology Clinic
  • Faliro, Greece, 185 47
    • Metropolitan Hospital Fourth Oncology Clinic
  • Heraklion, Greece, 711 10
    • University General Hospital of Heraklion
  • Ioannina, Greece, 455 00
    • University General Hospital of Ioannina
  • Larissa, Greece, 412 21
    • University General Hospital of Larissa
  • Marousi, Greece, 151 23
    • IASO Obstetrics Gynecology Clinic
  • Marousi, Greece, 151 25
    • Medical Center of Athens
  • Pátrai, Greece, 265 00
    • University General Hospital of Patras
  • Pátrai, Greece, 264 43
    • Olympion Clinic
  • Thessaloniki, Greece, 546 22
    • Bioclinic Thessaloniki
  • Thessaloniki, Greece, 564 29
    • Papageorgiou General Hospital Of Thessaloniki
  • Thessaloniki, Greece, 546 39
    • Interbalkan Medical Center of Thessaloniki
  • Thessaloniki, Greece, 552 36
    • St. Luke's Hospital
  • Thessaloniki
    • Pylaia, Thessaloniki, Greece, 570 01
      • European Interbalkan Medical Center
    • Pylaia, Thessaloniki, Greece, 570 01
      • European Interbalkan Medical Center; 3rd Department of Oncology
• Guatemala
  • Guatemala City, Guatemala, 01015
    • Grupo Medico Angeles
  • Guatemala City, Guatemala, 01010
    • Celan S.A.
  • Guatemala City, Guatemala, 01010
    • INTEGRA Cancer Institute
  • Guatemala City, Guatemala, 01010
    • Oncomedica
  • Guatemala City, Guatemala, 01234
    • Clínica Médica Especializada en Hematología
  • Salcajá, Guatemala, 09002
    • Centro Medico Integral de Cancerologia CEMIC
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Tuen Mun Hospital
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Budapest, Hungary, 1145
    • Budapesti Uzsoki Utcai Korhaz
  • Budapest, Hungary, 1136
    • Tolna Megyei Balassa Janos Korhaz
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Tatabánya, Hungary, 2800
    • Szent Borbala Korhaz
  • Zalaegersteg, Hungary, 8900
    • Zala Megyei Szent Rafael Kórház
• India
  • Andhra Pradesh
    • Vijayawada, Andhra Pradesh, India, 520002
      • HCG City Cancer Centre
  • Bihar
    • Patna, Bihar, India, 800014
      • State Cancer Institute, Indira Gandhi Institute of Medical Sciences (IGIMS)
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • Gujarat Cancer & Research Inst.
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital
    • Surat, Gujarat, India, 395004
      • Kiran Hospital Multi Super Speciality Hospital and Research Center
    • Vadodara, Gujarat, India, 391760
      • Kailash Cancer Hospital and Research Center
    • Vadodara, Gujarat, India, 390020
      • Himalaya Cancer Hospital & Research Institute
  • Karnataka
    • Belagavi, Karnataka, India, 590010
      • KLES Dr Prabhakar Kore Hospital and Medical Research Centre
  • Maharashtra
    • Amravati, Maharashtra, India, 444606
      • Sujan Surgical Cancer Hospital And Amravati Cancer Foundation
    • Kolhāpur, Maharashtra, India, 416234
      • Kolhapur Cancer Centre
    • Mumbai, Maharashtra, India, 400013
      • Tata Memorial Hospital
    • Nagpur, Maharashtra, India, 440003
      • Government Medical College
    • Nagpur, Maharashtra, India, 441110
      • Shalinitai Meghe Medical College and Hospital
    • Nashik, Maharashtra, India, 422002
      • HCG Manavata Cancer Centre
    • Nashik, Maharashtra, India, 422009
      • Apex Wellness Hospital
    • Nashik, Maharashtra, India, 422005
      • Chopda Medicare & Research Centre pvt. Ltd
    • Pune, Maharashtra, India, 411028
      • Sahyadri Super Specialty Hospital Hadapsar
    • Pune, Maharashtra, India, 411004
      • Sahyadri Speciality Hospital
    • Pune, Maharashtra, India, 411033
      • Lokmanya Holistic Cancer Care and Research Center (LMRC)
  • Tamil Nadu
    • Ratnagiri Kilminnal, Tamil Nadu, India, 632517
      • Christian Medical College-Ranipet Campus
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • King George Medical University (KGMU)
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
• Ireland
  • Cork, Ireland, T12 DV56
    • Bon Secours Hospital
  • Cork, Ireland, T12 DC4A
    • Cork University Hospital
  • Dublin, Ireland, D09 V2N0
    • Beaumont Hospital
  • Dublin, Ireland, D04 T6F4
    • St Vincents University Hospital
  • Galway, Ireland, H91 YR71
    • Galway University Hospital
  • Limerick, Ireland, V94 F858
    • Mid- Western Regional Hospital Limerick
  • Waterford, Ireland, X91 ER8E
    • Waterford Regional Hospital
• Israel
  • Beer Jacob, Israel, 0073100
    • Shamir Medical Center Assaf Harofeh
  • Beersheba, Israel, 84101
    • Soroka University Medical Centre
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center - PPDS
  • Tel Aviv, Israel, 6423906
    • Tel-Aviv Sourasky Medical Center
• Italy
  • Campania
    • Avellino, Campania, Italy, 83100
      • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
    • Naples, Campania, Italy, 80131
      • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS Azienda Ospedaliero Universitaria di Bologna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • Arcispedale Santa Maria Nuova
    • Roma, Emilia-Romagna, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele S.r.l. - PPDS
    • Milan, Lombardy, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
    • Milan, Lombardy, Italy, 20133
      • Istituto Nazionale Tumori Regina Elena
    • Rozzano (MI), Lombardy, Italy, 20089
      • Istituto Clinico Humanitas
  • Tuscany
    • Empoli, Tuscany, Italy, 50053
      • Ospedale San Giuseppe
    • Livorno, Tuscany, Italy, 57123
      • Azienda Usl Toscana nord ovest - Ospedali Riuniti di Livorno
    • Pisa, Tuscany, Italy, 56126
      • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Kagoshima, Japan, 892-0833
    • Social Medical Corporation Hakuaikai Sagara Hospital
  • Kitaadachi-gun, Japan, 362-0806
    • Saitama Cancer Center
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Sapporo, Japan, 003-0804
    • National Hospital Organization Hokkaido Cancer Center
  • Tokyo, Japan, 104-0044
    • St. Luke's International Hospital
  • Kanagawa
    • Isehara-Shi, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
  • Kumamoto
    • Kumamoto-Shi Chuo-Ku, Kumamoto, Japan, 860-0811
      • Kumamoto University Hospital
  • Okinawa
    • Naha, Okinawa, Japan, 901-0154
      • Nahanishi Clinic
  • Osaka
    • Osaka-Shi Chuo-Ku, Osaka, Japan, 540-0006
      • National Hospital Organization Osaka National Hospital
  • Tokyo
    • Koto-Ku, Tokyo, Japan, 135-0063
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• Kenya
  • Eldoret, Kenya, 30100
    • International Cancer Institute (ICI)
  • Nairobi, Kenya, 00100
    • The Aga Khan University-Kenya.
• Latvia
  • R?ga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
• Malaysia
  • FED. Territory of Kuala Lumpur
    • Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur
    • Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
  • Federal Territory of Putrajaya
    • Putrajaya, Federal Territory of Putrajaya, Malaysia, 62250
      • National Cancer Institute IKN
  • Kedah
    • Sungai Petani, Kedah, Malaysia, 08000
      • Pantai Hospital Sungai Petani
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10990
      • Hospital Pulau Pinang
  • Sarawak
    • Buzia?, Sarawak, Malaysia, 305100
      • Sarawak General Hospital
  • Selangor
    • Petaling Jaya, Selangor, Selangor, Malaysia, 46050
      • Beacon International Specialist Centre
• Mexico
  • Aguascalientes, Mexico, 20116
    • Centro de Investigacion Medica Aguascalientes
  • México, Mexico
    • Centro Oncológico Alianza XXI
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization
  • Puebla City, Mexico, CP 72530
    • Oncologica de Puebla S.A de C.V
  • San Luis Potosí City, Mexico, 78250
    • Oncologico Potosino
  • Toluca, Mexico, 50080
    • Centro Hemato-Oncologico Privado CHOP
  • Estado de Baja California
    • Mexicali, Estado de Baja California, Mexico, 21200
      • Centro de Investigación en Artritis y Osteoporosis - PPDS
  • Guanajuato
    • León, Guanajuato, Mexico, 37178
      • Preparaciones Oncológicas S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil Fray Antonio Alcalde
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64000
      • Accelerium S. de R.L. de C.V.
    • Monterrey, Nuevo León, Mexico
      • Hospital Universitario Dr. Jose Eleuterio González
  • Oaxaca
    • Oaxaca City, Oaxaca, Mexico, 68020
      • Centro de Investigacion Clinica de Oaxaca
  • Querétaro
    • Querétaro City, Querétaro, Mexico, 76000
      • Investigación Médica de Alta Especialidad
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Neurociencias Estudios Clinicos S.C.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97125
      • Merida | Investigacion Clinica
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Hospital
  • The Hague, Netherlands, 2545 AA
    • Hagaziekenhuis
  • Venlo, Netherlands, 5912 BL
    • VieCuri Medisch Centrum
• North Macedonia
  • Bitola, North Macedonia, 7000
    • PHI Clinical Hospital Dr Trifun Panovski Bitola
  • Skopje, North Macedonia, 1000
    • Acibadem Sistina Hospital
  • Skopje, North Macedonia, 1000
    • PHI University Clinic of Radiotherapy and Oncology
• Peru
  • Bellavista, Peru, 7016
    • Hospital Nacional Daniel A Carrion
  • Jesus Maria, Peru, Lima 11
    • Hospital Militar Central
  • Lima, Peru, 41
    • Oncosalud Sac
  • Lima, Peru, 15046
    • Hospital Central Fuerza Aerea Del Peru
  • Lima, Peru, 15072
    • Clínica Santa Beatriz
  • Lima, Peru, 27
    • Oncologia S.A.C. - Instituto Peruano de Oncología & Radioterapia
  • La Libertad
    • Trujillo, La Libertad, Peru, 13008
      • Clinica San Antonio;Investigaciones Trujillo S.A.C.
• Philippines
  • Baguio City, Philippines, 2600
    • Baguio General Hospital and Medical Center
  • Davao City, Philippines, 8000
    • Metro Davao Medical and Research Center
  • Iloilo City, Philippines, 5000
    • St. Paul's Hospital
  • Manila, Philippines, 1503
    • Cardinal Santos Medical Center
  • Pasig, Philippines, 1605
    • The Medical City
  • Quezon City, Philippines, 1102
    • St. Luke's Medical Center - Quezon City
  • Quezon City, Philippines, 1101
    • East Avenue Medical Center
  • Benguet
    • Baguio City, Benguet, Philippines, 2600
      • Saint Louis University Hospital of Sacred Heart
  • National Capital Region
    • Manila, National Capital Region, Philippines, 1015
      • University of Santo Tomas Hospital
  • Western Visayas (Region VI)
    • Bacolod City, Western Visayas (Region VI), Philippines, 6100
      • Riverside Medical Center, Inc.
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy
  • Gdynia, Poland, 81-519
    • Szpital Morski Im. Pck
  • Gliwice, Poland, 44-101
    • Narodowy Instytut Onkologii im. M.Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy Oddzia? Gliwice
  • Grudziądz, Poland, 86-300
    • Regionalny Szpital Specjalistyczny im. W. Bieganskiego
  • Krakow, Poland, 31-115
    • Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
  • Poznan, Poland, 60-192
    • Centrum Medyczne Pratia
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
• Portugal
  • Guimarães, Portugal, 4835-044
    • Hospital Senhora da Oliveira ? Guimaraes, E.P.E
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz
  • Lisbon, Portugal, 1050-034
    • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
  • Lisbon, Portugal, 1400-038
    • Champalimaud Cancer Center
  • Loures, Portugal, 2674-514
    • Hospital Beatriz Ângelo
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto ? Hospital de Santo António
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
  • Vila Real, Portugal, 5000-508
    • Centro Hospitalar Trás Os Montes E Alto Douro EPE
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1649-035
      • Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria
• Romania
  • Bucure?ti, Romania, 011171
    • Spitalul Clinic de Obstetrica si Ginecologie Filantropia
  • Cluj-Napoca, Romania, 400015
    • Prof Dr I Chiricuta Institute of Oncology
  • Cluj-Napoca, Romania, 400641
    • Medisprof SRL
  • Craiova, Romania, 200347
    • Oncology Center Sf. Nectarie
  • Craiova, Romania, 200516
    • Onco Clinic Consult SA
  • Iași, Romania, 707023
    • Institutul Regional de Oncologie Iasi
  • Timi?oara, Romania, 300595
    • Timisoara Emergency County Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia
  • Belgrade, Serbia, 11080
    • University Hospital Medical Center Bezanijska kosa
  • Kamenitz, Serbia, 21204
    • Oncology Institute of Vojvodina
  • Kladovo, Serbia, 19320
    • Health Center Kladovo
  • Zrenjanin, Serbia, 23000
    • General Hospital Djordje Joanovic - Zrenjanin
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny onkologicky ustav
  • Košice, Slovakia, 040 01
    • Východoslovenský Onkologický Ústav
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
• South Africa
  • Cape Town, South Africa, 7570
    • Cape Town Oncology Trials
  • Cape Town, South Africa, 7700
    • Cancercare Rondebosch Oncology
  • City of Johannesburg, South Africa, 2196
    • Sandton Oncology Medical Group (Pty) Ltd
  • George, South Africa, 6530
    • Excellentis Clinical Trial Consultants
  • Johannesburg, South Africa, 2196
    • Medical Oncology Centre of Rosebank
  • Port Elizabeth, South Africa, 6045
    • Langenhoven Drive Oncology Centre
  • Pretoria, South Africa, 0081
    • Eastleigh Breast Care Centre
• South Korea
  • Cheongju-si, South Korea, 361-711
    • Chungbuk National University Hospital
  • Gangwon-do, South Korea, 26426
    • Yonsei University Wonju Severance Christian Hospital
  • Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Centre
  • Incheon, South Korea, 22332
    • Inha University Hospital
  • Namdong-Gu, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongbuk-Gu, South Korea, 02841
    • Korea University Anam Hospital
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center - PPDS
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 3722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 6591
    • The Catholic University of Korea Seoul St. Mary?s Hospital
  • Seoul, South Korea
    • Samsung Medical Center - PPDS
  • Songpa-Gu, South Korea, 05505
    • Ulsan University Hosiptal
  • Suwon, South Korea, 443-721
    • Ajou University Hospital
  • Chungcheongnam-do
    • Cheonan-si, Chungcheongnam-do, South Korea, 330721
      • Soon Chun Hyang University Cheonan Hospital
• Spain
  • Albacete, Spain, 2006
    • Complejo Hospitalario Universitario de Albacete
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Alicante, Spain, 03550
    • Hospital Universitario San Juan
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08028
    • Hospital Universitario Quiron Dexeus
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08017
    • Clinica Tres Torres
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Cáceres, Spain, 10003
    • Hospital de San Pedro de Alcantara
  • Córdoba, Spain, 14004
    • Hospital General Universitario Reina Sofia
  • Girona, Spain, 17007
    • Institut Català D'Oncologia Girona
  • Granada, Spain, 18012
    • Hospital Universitario Virgen de las Nieves
  • Granada, Spain, 18007
    • Hospital Universitario Clínico San Cecilio
  • Huelva, Spain, 21005
    • Hospital Universitario Juan Ramon Jimenez
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaén
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro - Majadahonda
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Madrid, Spain, 28942
    • Hospital Universitario de Fuenlabrada
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz.
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro ? CIOCC
  • Madrid, Spain, 28027
    • Clinica Universidad Navarra
  • Madrid, Spain, 28007
    • IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center Madrid ? Espana
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de La Arrixaca
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41014
    • Hospital Nuestra Senora de Valme
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano de Oncologia (IVO)
  • Valladolid, Spain, 47005
    • Hospital Clinico Universitario de Valladolid
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Ávila, Spain, 05004
    • Hospital Nuestra Señora de Sonsoles
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07198
      • Hospital Son Llàtzer
    • Palma de Mallorca, Balearic Islands, Spain, 07120
      • Hospital Universitario Son Espases
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • ICO Badalona-H.U. Germans Trias i Pujol
    • Manresa, Barcelona, Spain, 08243
      • ALTHAIA Xarxa Assistencial de Manresa
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Burgos
    • Santiago de Compostela, Burgos, Spain, 15705
      • Hospital HM Nuestra Señora de la Esperanza
  • Cadiz
    • Jerez de la Frontera, Cadiz, Spain, 11407
      • Hospital de Jerez
  • Castellon
    • Castellon de LA Plana/castello de LA Plana, Castellon, Spain, 12002
      • Consorcio Hospitalario Provincial de Castellon
  • Guipuzcoa
    • Donostia / San Sebastian, Guipuzcoa, Spain, 20080
      • Hospital Universitario DE Donostia
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Hospital Universitario A Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • CHUS H Clinico U de Santiago
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Hospital Universitario Insular de Gran Canaria
  • Lerida
    • Lleida, Lerida, Spain, 25198
      • Hospital Universitari Arnau de Vilanova
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Complejo Hospitalario de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • CHUVI ? H.U. Alvaro Cunqueiro
  • Sevilla
    • Seville, Sevilla, Spain, 41071
      • Hospital Universitario Virgen Macarena
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitari Sant Joan de Reus
  • Tenerife
    • S. Cristobal de La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto
• Sweden
  • Jönköping, Sweden, 553 05
    • Länssjukhuset Ryhov
  • Stockholm, Sweden, 11883
    • Sodersjukhuset
  • Sundsvall, Sweden, 851 86
    • Sundsvalls sjukhus
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
  • Västerås, Sweden, 721 89
    • Västmanlands Sjukhus Västerås
• Switzerland
  • Aarau, Switzerland, 5000
    • Tumorzentrum Aarau
  • Baden, Switzerland, 5404
    • Kantonsspital Baden
  • Basel, Switzerland, 4031
    • Universitatsspital Basel
  • Bern, Switzerland, 3010
    • Universitätsspital Bern
  • Chur, Switzerland, 7000
    • Kantonsspital Graubünden KSGR
  • Lucerne, Switzerland, 6000
    • Luzerner Kantonsspital LUKS
  • Lucerne, Switzerland, 6006
    • Hirslanden Klinik St. Anna
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
  • Thun, Switzerland, 3600
    • Spital STS AG Thun - Berner Oberland
  • Winterthur, Switzerland, 8400
    • Kantonsspital Winterthur Medizin Pneumologie
  • Zürich (de)
    • Zurich, Zürich (de), Switzerland, 8008
      • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
• Taiwan
  • Changhua County, Taiwan, 50006
    • Changhua Christian Medical Foundation Changhua Christian Hospital
  • Hsinchu, Taiwan, 300
    • Hsin-Chu Branch of National Taiwan University Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 70457
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 71044
    • Chi Mei Medical Cente
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital - Taipei Branch
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Memorial Hospital - Linkou
  • Xitun Dist., Taiwan, 40705
    • Taichung Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok Noi, Thailand, 10700
    • Siriraj Hospital, Mahidol University
  • Bangkok Metropolis
    • Ratchathewi, Bangkok Metropolis, Thailand, 10400
      • Ramathibodi Hospital Mahidol University
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Antalya, Turkey (Türkiye), 07059
    • Akdeniz University Medical Faculty
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34722
    • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Izmir, Turkey (Türkiye), 35101
    • Izmir Medical Point Hospital
  • Izmir, Turkey (Türkiye), 35360
    • Katip Celebi University- Izmir Ataturk Egitim ve Arastirma Hastanesi
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
  • Samsun, Turkey (Türkiye), 55239
    • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  • Seyhan/Adana, Turkey (Türkiye), 01130
    • Ac?badem Adana Hospital, Oncology Department
  • Yen?mahalle, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Üsküdar, Turkey (Türkiye), 34662
    • Acibadem Altunizade Hospital
  • Adana
    • Sariçam, Adana, Turkey (Türkiye), 01250
      • Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi
• Uganda
  • Kampala, Uganda
    • St Francis Hospital Nsambya
  • Kampala, Uganda, 99999
    • Uganda Cancer Institute
• Ukraine
  • Vinnytsia, Ukraine, 21009
    • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • KIEV Governorate
    • Chernihiv, KIEV Governorate, Ukraine, 14029
      • Communal Non-Profit Enterprise Chernihiv Medical Center of Modern Oncology of CRC
    • Kyiv, KIEV Governorate, Ukraine, 03039
      • Clinic Verum Expert LLC
• United Kingdom
  • Leicester, United Kingdom, LE2 7LX
    • Leicester Royal Infirmary
  • London, United Kingdom
    • University College London Hospitals
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Southern Cancer Center
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research Inc., at Comprehensive Blood and Cancer Center
    • Fullerton, California, United States, 92835
      • St Joseph Heritage Healthcare
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center
    • Los Alamitos, California, United States, 90720
      • Cancer Blood and Specialty Clinic
    • Orange, California, United States, 92868
      • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
    • San Diego, California, United States, 92120
      • Kaiser Permanente - San Diego
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology
    • Torrance, California, United States, 90505
      • Torrance Memorial Physician Network/Cancer Care
    • Vallejo, California, United States, 94589
      • Kaiser Permanente - Vallejo
  • Colorado
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers (Longmont) - USOR
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Stamford Hospital
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System - Memorial Regional Hospital
    • Jacksonville, Florida, United States, 32207
      • Baptist - MD Anderson Cancer Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital
    • Tinley Park, Illinois, United States, 60487
      • Duly Health and Care
  • Kansas
    • Kingman, Kansas, United States, 67068
      • Cancer Center of Kansas - Kingman
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute - MDC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology/Oncology Clinic, LLP
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
  • Maryland
    • Towson, Maryland, United States, 21204
      • University of Maryland
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Med Ctr
    • Lexington, Massachusetts, United States, 02421
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro-Minnesota Community Oncology Research Consortium
  • Missouri
    • Columbia, Missouri, United States, 65203
      • University of Missouri-Columbia
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130-2042
      • Nebraska Cancer Specialists
  • Nevada
    • Las Vegas, Nevada, United States, 89135
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Hematology Oncology
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10016
      • New York University Cancer Cen
    • Stony Brook, New York, United States, 11794
      • Stony Brook Univ Cancer Ctr
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Messino Cancer Centers
    • Raleigh, North Carolina, United States, 27607
      • Rex Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center - PPDS
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43212
      • Stefanie Spielman Comprehensive Breast Center
    • Columbus, Ohio, United States, 43125
      • Columbus NCORP
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon, P.C.
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente-Northwest Region
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17109
      • Pinnacle Health
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Univ. Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital
    • Pittsburgh, Pennsylvania, United States, 15212-4737
      • Allegheny Cancer Center
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Tennessee
    • Germantown, Tennessee, United States, 38138-1762
      • West Cancer Center & Research Institute
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute / Tennessee Oncology
  • Texas
    • El Paso, Texas, United States, 79902
      • Texas Oncology, P.A. - El Paso
    • Flower Mound, Texas, United States, 75028
      • Texas Oncology (Flower Mound) - USOR
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology-Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research & Treatment Center
    • McAllen, Texas, United States, 78503
      • Texas Oncology (McAllen) - USOR
    • San Antonio, Texas, United States, 78217
      • USOR - Texas Oncology - San Antonio Northeast
    • Tyler, Texas, United States, 75702-8363
      • Texas Oncology (Tyler) - USOR
    • Waco, Texas, United States, 76712
      • Texas Oncology (Waco) - USOR
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Alan B. Pearson Regional Cancer Center
    • Midlothian, Virginia, United States, 23114
      • Bon Secours Mercy Health
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University - Massey Cancer Center
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
  • West Virginia
    • Morgantown, West Virginia, United States, 26056
      • West Virginia University Hospitals Inc
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
• Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity
• Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
• Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.
• Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)
• Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
• Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.
• Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
• Able and willing to swallow, retain, and absorb oral medication
• Adequate organ function

Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice
• Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
• Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed.
• Active cardiac disease or history of cardiac dysfunction
• Diagnosed with Stage IV breast cancer
• A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
• A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer
• Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed.
• Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
• Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
• Known allergy or hypersensitivity to any of the study drugs or any of their excipients
• Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists
• A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
• Renal dysfunction that requires dialysis
• A major surgical procedure unrelated to breast cancer within 28 days prior to randomization
• A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
• Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

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: Arm A: Giredestrant	Drug: Giredestrant; Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).; Other Names: GDC-9545; RO7197597; RG6171; Drug: LHRH Agonist; A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Active Comparator: Arm B: Physician's Choice of Endocrine Therapy	Drug: LHRH Agonist; A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.; Drug: Physician's Choice of Endocrine Therapy; The physician's choice of endocrine therapy (PCET) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive PCET daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing PCET after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of PCET should be performed in accordance with the local prescribing information for the respective product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers	From randomization to first occurrence of an IDFS event (up to 10 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	From randomization to death from any cause (up to 10 years)
Invasive Disease-Free Survival (IDFS), Including Second Primary Non-Breast Cancers	From randomization to first occurrence of an IDFS event (up to 10 years)
Disease-Free Survival (DFS)	From randomization to first occurrence of a DFS event (up to 10 years)
Distant Recurrence-Free Interval (DRFI)	From randomization to first occurrence of a DFRI event (up to 10 years)
Locoregional Recurrence-Free Interval (LRRFI)	From randomization to first occurrence of a LRRFI event (up to 10 years)
Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the EQ 5D-5L Index-Based Score at Specified Timepoints	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the EQ 5D-5L Visual Analogue Scale (VAS) Score at Specified Timepoints	Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)	From start of treatment until 28 days after the final dose of study treatment (up to 5 years)
Plasma Concentrations of Giredestrant at Specified Timepoints	Predose and 3-4 hours postdose on Day 1 of Cycles 1 and 2, and predose on Day 1 of Cycles 3 and 6 (1 cycle is 28 days)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): August 8, 2025
• Study Completion (Estimated): September 30, 2033

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

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; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone; giredestrant
• Other Study ID Numbers: GO42784; 2021-000129-28 (EudraCT Number); 2023-507172-44-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

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