A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
September 10, 2026 updated by: Hoffmann-La Roche
A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Study Overview
Status
Status
Active, not recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Estimated)
Enrollment
1050
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: CO44657 https://forpatients.roche.com/ No attachments to email below.
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Buenos Aires, Argentina, C1113AAE
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
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Buenos Aires, Argentina, C1417DTB
- Inst. de Oncologia Angel H. Roffo
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Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
- Centro Oncológico Korben
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Córdoba, Argentina, X5000JHQ
- Sanatorio Allende
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (Cori)
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Recoleta, Argentina, C1118AAT
- Hospital Aleman
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Rosario, Argentina, S2000KZE
- Instituto de Oncologia de Rosario
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Rosario, Argentina, S2002KDS
- Hospital Provincial del Centenario
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San Juan, Argentina, J5400
- Centro Oncológico de Excelencia
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New South Wales
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Frenchs Forest, New South Wales, Australia, 2086
- Northern Beaches Hospital
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Kingswood, New South Wales, Australia, 2747
- Nepean Hospital
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North Sydney, New South Wales, Australia, 2060
- Mater Hospital
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Queensland
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Buderim, Queensland, Australia, 4556
- Sunshine Coast Haematology and Oncology Clinic
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South Brisbane, Queensland, Australia, 4101
- Mater Misericordiae Limited
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South Australia
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Adelaide, South Australia, Australia
- Cancer Research SA
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Victoria
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Geelong, Victoria, Australia, 3220
- Barwon Health
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St Albans, Victoria, Australia, 3021
- Sunshine Hospital
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Graz, Austria, 8036
- Lkh-Univ. Klinikum Graz
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Linz, Austria, 4010
- Ordensklinikum Linz Barmherzige Schwestern
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Steyr, Austria, 4400
- Oö. Gesundheits- und Spitals-AG/LKH Steyr
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Brussels, Belgium, 1200
- Cliniques Universitaires St-Luc
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Ghent, Belgium, 9000
- UZ Gent
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Liège, Belgium, 4000
- CHU de Liège (Sart Tilman)
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Namur, Belgium, 5000
- Clinique Ste-Elisabeth
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Wilrijk, Belgium, 2610
- ZAS Sint Augustinus Wilrijk
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Rio de Janeiro, Brazil, 22281-100
- Instituto D'Or de Pesquisa e Ensino
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Ceará
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Fortaleza, Ceará, Brazil, 60336-232
- CRIO - Centro Regional Integrado de Oncologia
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29055-450
- CEDOES - Diagnóstico e Pesquisa
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 40415-006
- Obras Sociais Irma Dulce - Osid
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Federal District
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Brasília, Federal District, Brazil, 70200-730
- Hospital Sírio-Libanês
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Goiás
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Goiânia, Goiás, Brazil, 74605-070
- Hospital Araujo Jorge
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Maranhão
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São Luís, Maranhão, Brazil, 65060-645
- Hospital Sao Domingos
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Paraná
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Londrina, Paraná, Brazil, 86015-520
- Hospital do Câncer de Londrina
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Pernambuco
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Recife, Pernambuco, Brazil, 50040-000
- Hospital do Cancer de Pernambuco - HCP
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Piauí
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Teresina, Piauí, Brazil, 64049-200
- Vencer Oncoclínica - Centro de Pesquisa do Piauí
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
- Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Hospital Sao Lucas - PUCRS
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
- Hospital Moinhos de Vento
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São Paulo
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Barretos, São Paulo, Brazil, 14784-400
- Hospital de Cancer de Barretos
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Jaú, São Paulo, Brazil, 17210-120
- Hospital Amaral Carvalho
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São Paulo, São Paulo, Brazil, 01509-010
- Hospital A. C. Camargo
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São Paulo, São Paulo, Brazil, 01317-001
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
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São Paulo, São Paulo, Brazil, 01308-050
- Hospital Sírio-Libanês
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Royal Victoria Regional Health Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health Oshawa
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Thunder Bay, Ontario, Canada, P7B 6V4
- Thunder Bay Regional Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Center
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Toronto, Ontario, Canada, M2K 1E1
- North York General Hospital
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
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Lévis, Quebec, Canada, G6V 3Z1
- CISSS Chaudière-Appalaches
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Montreal, Quebec, Canada, H2X 0C2
- Centre hospitalier de l'Université de Montréal (CHUM)
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Québec, Quebec, Canada, G1S 4L8
- CHU de Québec - Hôpital du Saint-Sacrement
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Saint-Jérôme, Quebec, Canada, J7Z 5T3
- Hopital regional de saint jerome
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Trois-Rivières, Quebec, Canada, G8Z 3R9
- Centre hospitalier regional de Trois-Rivieres
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, SK S7N 4H4
- Saskatoon Cancer Centre
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Las Condes, Chile, 7560908
- Medicina de Precisión - Celerity
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Port Montt, Chile, 5500243
- Clínica Puerto Montt
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Providencia, Chile, 750000
- Oncovida
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Santiago, Chile, 8380000
- Instituto Nacional del Cancer
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Santiago, Chile
- Icegclinic
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Santiago, Chile, 8330032
- Centro De Cancer Universidad Catolica
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Región Bio Bio
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Concepción, Región Bio Bio, Chile, Alto Horno 777
- Hospital Las Higueras
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Beijing, China, 100142
- Beijing Cancer Hospital
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Changchun, China, 130021
- The First Hospital of Jilin University
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Changsha, China, 410013
- Hunan Cancer Hospital
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Chengdu, China, 610041
- West China Hospital of Sichuan University
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Chengdu, China, 610072
- Sichuan Provincial People's Hospital
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Fuzhou, China, 350001
- Fujian Medical University Union Hospital
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Fuzhou, China, 350009
- No. 900 Hospital (Fuzhou General Hospital)
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Guangzhou, China, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, China, 310009
- The Second Affiliated Hospital of Zhejiang University College
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Harbin, China, 150081
- Harbin Medical University Cancer Hospital
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Jinan, China, 250117
- Shandong Cancer Hospital
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Jinan, China, 250013
- Jinan Central Hospital
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Kunming, China, 650034
- The First People's Hospital of Yunnan Province
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Luoyang, China, 471031
- The First Affiliated Hospital to Henan University of Science and Technology
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Nanning, China, 530021
- Guangxi Cancer Hospital of Guangxi Medical University
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Shanghai, China, 200032
- Zhongshan Hospital Fudan University
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Shanghai, China, 200120
- Fudan University Shanghai Cancer Center
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Taiyuan, China, 030013
- Shanxi Province Cancer Hospital
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Tianjin, China
- Tianjin Cancer Hospital
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Wuhan, China, 430079
- Hubei Cancer Hospital
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Wuhan, China, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Xi'an, China, 710100
- Xi'an International Medical Center Hospital
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Xi'an, China, 710004
- The Second Affiliated Hospital of Xi'an Jiao Tong University
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Xuzhou, China
- The Affiliated Hospital of Xuzhou Medical University
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Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Zhengzhou, China, 450052
- The First Affiliated Hospital of Zhengzhou University
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Ürümqi, China, 830000
- The Tumor Hospital of Xinjiang Medical University
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Bogota, D.C., Colombia, 110131
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
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Bogotá D.C., Colombia, 51000
- Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
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Cali, Colombia
- IPS Salud SURA Chipichape Cali
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Montería, Colombia, 230002
- Oncomedica S.A.
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Valledupar, Colombia, 200001
- Sociedad de Oncología y hematología del Cesar Ltda
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San José, Costa Rica, 10103
- Clinica CIMCA
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San José, Costa Rica, 10108
- ICIMED Instituto de Investigación en Ciencias Médicas
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Tampere, Finland, 33520
- Tampere University Hospital
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Angers, France, 49055
- ICO Paul Papin
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Avignon, France, 84918
- Institut Sainte Catherine
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Besançon, France, 25030
- Hôpital Jean Minjoz
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Caen, France, 14076
- Centre François Baclesse
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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La Rochelle, France, 17019
- Centre Hospitalier Saint Louis
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Lille, France, 59020
- Centre Oscar Lambret
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Lyon, France, 69373
- Centre Léon Bérard
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Montpellier, France, 34070
- Centre Cancerologie Grand Montpellier
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Reims, France, 51056
- Institut Jean Godinot
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Rennes, France, 35042
- Centre Eugene Marquis
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Toulouse, France, 31100
- IUCT Oncopole
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Villejuif, France, 94805
- Gustave Roussy
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Bamberg, Germany, 96049
- Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
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Cologne, Germany, 50935
- St. Elisabeth Krankenhaus Köln GmbH
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Düsseldorf, Germany, 40235
- Gynonco Düsseldorf, MVZ Medical Center GmbH
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Erlangen, Germany, 91054
- Universitätsklinikum Erlangen
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Essen, Germany, 45136
- Kliniken Essen-Mitte
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Freiburg im Breisgau, Germany, 79110
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
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Heidelberg, Germany, 69120
- Nationales Centrum für Tumorerkrankungen (NCT)
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Homburg/Saar, Germany, 66424
- Universitatsklinikum des Saarlandes
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Mönchengladbach, Germany, 41061
- Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
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München, Germany, 80637
- Rotkreuzklinikum München
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Athens, Greece, 115 22
- Anticancer Hospital Ag. Savas
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Athens, Greece, 115 28
- Aretaieio Hospital of Athens
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Larissa, Greece, 411 10
- University Hospital of Larissa
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Pátrai, Greece, 265 04
- University Hospital of Patras Medical Oncology
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Thessaloniki, Greece, 570 01
- European Interbalkan Medical Center
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Guatemala City, Guatemala, 01015
- Grupo Angeles
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Guatemala City, Guatemala, 01010
- Celan S.A.
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Guatemala City, Guatemala, 01010
- INTEGRA Cancer Institute
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Guatemala City, Guatemala, 01009
- Oncomedica
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Guatemala City, Guatemala, 01010
- Onco Go, S.A.
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Guatemala City, Guatemala, 01016
- Medi-k
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Salcajá, Guatemala, 09002
- Centro Medico Integral de Cancerologia CEMIC
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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Budapest, Hungary, 1122
- Országos Onkológiai Intézet
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Kecskemét, Hungary, 6000
- Bacs-Kiskun Varmegyei Oktatokorhaz
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Miskolc, Hungary, 3526
- B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház
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Salgótarján, Hungary, 3100
- Nograd Varmegyei Szent Lazar Korhaz
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Karnataka
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Banglore, Karnataka, India, 560027
- HealthCare Global Enterprises Limited
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Kerala
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Kozhikode, Kerala, India, 673601
- MVR Cancer Centre and Research Institute
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Trivandrum, Kerala, India, 695011
- Regional Cancer Centre
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Maharashtra
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Mumbai, Maharashtra, India, 400004
- Sir H. N. Reliance Foundation Hospital and Research Centre
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Pune, Maharashtra, India, 411004
- Sahyadri Super Speciality Hospital
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Pune, Maharashtra, India, 411001
- Grant Medical Foundation, Ruby Hall Clinic
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Thane, Maharashtra, India, 400615
- Sunact Cancer Institute
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Jerusalem, Israel, 9112000
- Hadassah Ein Karem Hospital
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Petah Tikva, Israel, 4910000
- Rabin Medical Center
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Ramat Gan, Israel, 5265601
- Sheba MC
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Tel Aviv, Israel, 6423900
- Sourasky Medical Center
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Apulia
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Brindisi, Apulia, Italy, 72100
- Presidio Ospedaliero di Summa-Perrino
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Campania
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Avellino, Campania, Italy, 83100
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
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Naples, Campania, Italy, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
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Naples, Campania, Italy, 80131
- Azienda Ospedaliera Universitaria Federico II
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Policlinico S.Orsola-Malpighi
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Meldola, Emilia-Romagna, Italy, 47014
- I.R.S.T Srl IRCCS
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Parma, Emilia-Romagna, Italy, 43100
- A.O. Universitaria Di Parma
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Friuli Venezia Giulia
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Aviano (PN), Friuli Venezia Giulia, Italy, 33081
- RCCS - Centro di Riferimento
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Udine, Friuli Venezia Giulia, Italy, 33100
- A.O. Universitaria S. Maria Della Misericordia Di Udine
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Lazio
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Rome, Lazio, Italy, 128
- Università Campus Bio-Medico di Roma
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Rome, Lazio, Italy, 00168
- Policlinico Universitario Agostino Gemelli
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Lombardy
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Bergamo, Lombardy, Italy, 24127
- Asst Papa Giovanni Xxiii
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Brescia, Lombardy, Italy, 25123
- ASST degli Spedali Civili di Brescia
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Cremona, Lombardy, Italy, 26100
- Asst Di Cremona
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Milan, Lombardy, Italy, 20133
- Irccs Istituto Nazionale Dei Tumori (Int)
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Rozzano, Lombardy, Italy, 20089
- Istituto Clinico Humanitas
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Piedmont
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Novara, Piedmont, Italy, 28100
- A.O.U. Maggiore della Carita
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Sicily
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Misterbianco (CT), Sicily, Italy, 95045
- Humanitas Centro Catanese Di Oncologia
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The Marches
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Province of Macerata, The Marches, Italy, 62100
- Ospedale Di Macerata
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Tuscany
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Florence, Tuscany, Italy, 50134
- Azienda Ospedaliera Universitaria Careggi
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Veneto
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Padova, Veneto, Italy, 35128
- IOV - Istituto Oncologico Veneto - IRCCS
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Nairobi, Kenya
- University of Nairobi - Institute of Tropical and Infectious Diseases
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Mexico City, Mexico, 03100
- CENEIT Oncologicos
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Mexico City, Mexico, 04010
- Clinica Alivia sucursal Coyoacan
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Jalisco
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Guadalajara, Jalisco, Mexico, 44670
- Panamerican Clinical Research S.A de C.V.
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Guadalajara, Jalisco, Mexico, 44680
- RENATI INNOVATION S.A.P.I. de C.V
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Mexico CITY (federal District)
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Mexico City, Mexico CITY (federal District), Mexico, 06760
- Centro de Atencion Oncologica Viva S de RL de CV
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Mexico City, Mexico CITY (federal District), Mexico, 03240
- Productos y Servicios Oncologicos Acacias SA de CV
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Nuevo León
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Monterrey, Nuevo León, Mexico
- Hospital Zambrano Hellion TecSalud
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Oaxaca
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Oaxaca City, Oaxaca, Mexico, 68020
- Centro de Investigacion Clinica de Oaxaca
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Querétaro
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Queréaro, Querétaro, Mexico, 76230
- PanAmerican Clinical Research, Querétaro
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Christchurch, New Zealand
- Christchurch Hospital
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Palmerston North, New Zealand, 4442
- Palmerston North Hospital
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Whangarei, New Zealand, 0110
- Whangarei Hospital
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Arequipa, Peru, 04001
- Centro Medico Monte Carmelo
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Arequipa, Peru, 5154
- Hospital Goyeneche
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Lima, Peru, Lima 34
- Instituto Nacional de Enfermedades Neoplasicas
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Lima, Peru, 41
- Oncosalud Sac
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Lima, Peru, 1
- Hospital Nacional Arzobispo Loayza
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Lima, Peru
- Instituto Peruano de Oncología y Radioterapia
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Lima, Peru, 15072
- Clínica Santa Beatriz
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Lima, Peru, Lima 41
- Clinica Internacional, Sede San Borja
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Trujillo, Peru, 13008
- Clinica San Antonio;Investigaciones Trujillo S.A.C.
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?ód?, Poland, 93-338
- Instytut "Centrum Zdrowia Matki Polki"
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Bydgoszcz, Poland, 85-796
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
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Gdynia, Poland, 81-519
- Szpital Morski Im. Pck
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Gliwice, Poland, 44-102
- Narodowy Instytut Onkologii Odzia? w Gliwicach
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Kielce, Poland, 25-734
- ?wi?tokrzyskie Centrum Onkologii
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Konin, Poland, 62-500
- Przychodnia Lekarska KOMED, Roman Karaszewski
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Koszalin, Poland, 75-581
- Szpital Wojewódzki im. Miko?aja Kopernika
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Lublin, Poland, 20-090
- Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
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Siedlce, Poland, 08-110
- Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II
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Szczecin, Poland, 71-730
- Zachodniopomorskie Centrum Onkologii
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Warsaw, Poland, 02-781
- Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
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Coimbra, Portugal, 3000-075
- IPO de Coimbra
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Lisbon, Portugal, 1500-650
- Hospital da Luz
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Lisbon, Portugal, 1495-005
- Hospital de S. Francisco Xavier
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Porto, Portugal, 4200-072
- IPO do Porto
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Vila Nova de Gaia, Portugal, 4434-502
- CHVNG/E_Unidade 1
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San Juan, Puerto Rico, 00935
- PanOncology Trials
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Bucharest, Romania, 011171
- Spitalul Clinic Filantropia
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Bucharest, Romania, 022328
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
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Cluj-Napoca, Romania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
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Iași, Romania, 700483
- Institutul Regional de Oncologie Iasi
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Timișoara, Romania, 300239
- Centrul de Oncologie Oncohelp
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Singapore, Singapore, 119228
- National University Hospital
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Singapore, Singapore, 168583
- National Cancer Centre
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
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Port Elizabeth, South Africa, 6045
- Cancercare
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Pretoria, South Africa, 0002
- Steve Biko Academic Hospital
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Soweto, South Africa, 2013
- Wits Clinical Research
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Daegu, South Korea, 41404
- Kyungpook National University Chilgok Hospital
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Seongnam-si, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 05505
- Asan Medical Center
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Seoul, South Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 02841
- Korea University Anam Hospital
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Seoul, South Korea, 06273
- Gangnam Severance Hospital
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Seoul, South Korea, 135-710
- Samsung Medical Center
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Seoul, South Korea, 07985
- Ewha Womans University Mokdong Hospital
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Ulsan, South Korea, 44033
- Ulsan University Hosiptal
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 08028
- Hospital Universitari Dexeus - Grupo Quironsalud
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Huelva, Spain, 21005
- Hospital Juan Ramón Jiménez
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Jaén, Spain, 23007
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
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Madrid, Spain, 28033
- Centro Oncologico MD Anderson Internacional
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Madrid, Spain, 28050
- Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
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Seville, Spain, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spain, 41009
- Hospital Universitario Virgen Macarena
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Valencia, Spain, 46015
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
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Valencia, Spain, 46009
- Instituto Valenciano Oncologia
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Institut Catala d?Oncologia Hospital Germans Trias i Pujol
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Cadiz
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Jerez de la Frontera, Cadiz, Spain, 11407
- Hospital de Jerez de la Frontera
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spain, 28223
- Hospital Quiron de Madrid
-
-
Murcia
-
EL Palmar (EL Palmar), Murcia, Spain, 30120
- Hospital Universitario Virgen de la Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, Spain, 36213
- Hospital Alvaro Cunqueiro
-
-
-
-
-
Hsinchu, Taiwan, 300
- Hsin-Chu Branch of National Taiwan University Hospital
-
Taichung, Taiwan, 404
- China Medical University Hospital
-
Taipei, Taiwan, 11259
- Koo Foundation Sun Yat-Sen Cancer Center
-
Taipei, Taiwan, 100
- National Taiwan Uni Hospital
-
Taipei, Taiwan, 00112
- Veterans General Hospital
-
Xitun Dist., Taiwan, 40705
- Veterans General Hospital - Taichung
-
-
-
-
-
Bangkok, Thailand, 10400
- Rajavithi Hospital
-
Bangkok, Thailand, 10400
- National Cancer Institute
-
Bangkok, Thailand, 10330
- Chulalongkorn Hospital
-
Lak Si, Thailand, 10210
- Chulabhorn Hospital
-
Muang Chiang MAI Delivery Branch 3, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology
-
Songkhla, Thailand, 90110
- Songklanagarind Hospital
-
-
-
-
-
Adapazarı, Turkey (Türkiye), 54290
- Sakarya Training and Research Hospital
-
Ankara, Turkey (Türkiye), 06800
- Ankara City Hospital
-
Bakirkoy / Istanbul, Turkey (Türkiye), 34147
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
-
Izmir, Turkey (Türkiye), 35360
- Izmir Ataturk Training and Research Hospital
-
Kadiköy, Turkey (Türkiye), 34722
- Goztepe Prof.Dr. Suleyman Yalcin City Hospital
-
Mersin, Turkey (Türkiye), 33240
- Mersin City Education and Research Hospital
-
Samsun, Turkey (Türkiye), 55200
- Medikal Park Samsun
-
Sihhiye/Ankara, Turkey (Türkiye), 06230
- Hacettepe Uni Medical Faculty Hospital
-
-
-
-
Alabama
-
Daphne, Alabama, United States, 36526
- Southern Cancer Center
-
-
California
-
Greenbrae, California, United States, 94904
- Marin Cancer Care Inc
-
Harbor City, California, United States, 90710
- Kaiser Permanente - Harbor City
-
Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90017
- Oncura Health
-
Torrance, California, United States, 90502
- The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
-
-
Colorado
-
Littleton, Colorado, United States, 80120-4413
- Rocky Mountain Cancer Centers
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Georgetown University Medical Center
-
Washington D.C., District of Columbia, United States, 20010
- MedStar Washington Hosp Center
-
-
Florida
-
Altamonte Springs, Florida, United States, 32701
- AdventHealth Altamonte
-
Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists - Broadway
-
Jacksonville, Florida, United States, 32256
- Cancer Specialists of North Florida
-
St. Petersburg, Florida, United States, 33701-4553
- Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
-
St. Petersburg, Florida, United States, 33709
- Comprehensive Hematology Oncology
-
West Palm Beach, Florida, United States, 33401-3406
- Florida Cancer Specialists - EAST - SCRI - PPDS
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Winship Cancer Institute of Emory University
-
-
Kentucky
-
Louisville, Kentucky, United States, 40207
- Baptist Health Louisville
-
-
Maine
-
Scarborough, Maine, United States, 04074
- New England Cancer Specialists
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Maryland Oncology Hematology
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
Missouri
-
Kansas City, Missouri, United States, 64132
- HCA Midwest Division
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Oncology Hematology West - Grand Island
-
Omaha, Nebraska, United States, 68130-2042
- Oncology Hematology West - Legacy
-
-
New Jersey
-
East Brunswick, New Jersey, United States, 08816
- Astera Cancer Care East Brunswick
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27607
- Duke Women Cancer Care
-
-
Oregon
-
Medford, Oregon, United States, 97504-8332
- Asante Rogue Regional Medical Center
-
-
Pennsylvania
-
Bensalem, Pennsylvania, United States, 19020
- Alliance Cancer Specialists
-
Lancaster, Pennsylvania, United States, 17604
- Ann B. Barshinger Cancer Institute
-
Philadelphia, Pennsylvania, United States, 19106
- Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Brown University Health
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- West Cancer Center
-
Nashville, Tennessee, United States, 37203
- SCRI Oncology Partners
-
-
Texas
-
Austin, Texas, United States, 78731
- Texas Oncology Cancer Center
-
Irving, Texas, United States, 75063
- Texas Oncology - DFW
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists, PC
-
Richmond, Virginia, United States, 23219
- Virginia Commonwealth University - Massey Cancer Center
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Northwest Medical Specialties
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26056
- West Virginia University Hospitals Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
- Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
- Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after >/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred >/=12 months since completion).
- No prior systemic anti-cancer therapy for advanced disease
- Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Exclusion Criteria:
- Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
- Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- Active cardiac disease or history of cardiac dysfunction
- Clinically significant history of liver disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Giredestrant + Investigator's Choice of CDK4/6i
Participants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.
|
Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
Other Names:
If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.
If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.
F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients.
It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected [ESR1m] vs. no mutation detected [ESR1nmd]).
Other Names:
|
|
Active Comparator: Fulvestrant + Investigator's Choice of CDK4/6i
Participants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.
|
If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.
If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.
F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients.
It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected [ESR1m] vs. no mutation detected [ESR1nmd]).
Other Names:
Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup
Time Frame: From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)
|
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
|
From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)
|
|
PFS in the Full Analysis Set (FAS) Population
Time Frame: From randomization to first occurrence of PD or death (up to 5 years)
|
From randomization to first occurrence of PD or death (up to 5 years)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup
Time Frame: From randomization to first occurrence of PD or death (up to 5 years)
|
From randomization to first occurrence of PD or death (up to 5 years)
|
|
|
Overall Survival (OS)
Time Frame: From randomization until death from any cause (up to 5 years)
|
OS is defined as the time from randomization to death from any cause.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until death from any cause (up to 5 years)
|
|
Confirmed Objective Response Rate (cORR)
Time Frame: From randomization until treatment discontinuation (up to 5 years)
|
The cORR is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart, as determined by the investigator according to RECIST v1.1.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until treatment discontinuation (up to 5 years)
|
|
Duration of Response (DOR)
Time Frame: From the first occurrence of a documented objective response to PD or death (up to 5 years)
|
DOR is defined as the time from the first occurrence of a documented objective response to PD, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From the first occurrence of a documented objective response to PD or death (up to 5 years)
|
|
Clinical Benefit Rate (CBR)
Time Frame: From randomization until treatment discontinuation (up to 5 years)
|
The CBR is defined as the percentage of participants with stable disease for at least (≥)24 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until treatment discontinuation (up to 5 years)
|
|
Time to Chemotherapy
Time Frame: From randomization until the start of chemotherapy or death (up to 5 years)
|
Time to chemotherapy is defined as the time from randomization until the start date of the first chemotherapy or death from any cause (whichever occurs first).
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until the start of chemotherapy or death (up to 5 years)
|
|
Time to Confirmed Deterioration (TTCD) in Pain Severity
Time Frame: From randomization until end of follow-up (up to 5 years)
|
TTCD in pain severity is defined as the time from randomization to the first documentation of ≥2-point increase from baseline on the "worst pain" item score of the Brief Pain Inventory-Short Form (BPI-SF).
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until end of follow-up (up to 5 years)
|
|
TTCD in Pain Presence and Interference
Time Frame: From randomization until end of follow-up (up to 5 years)
|
TTCD in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score, as determined using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) questionnaire.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until end of follow-up (up to 5 years)
|
|
TTCD in Physical Functioning
Time Frame: From randomization until end of follow-up (up to 5 years)
|
TTCD in physical functioning (PF) is defined as the time from randomization to the first documentation of ≥10-point decrease in PF score, as determined using the EORTC QLQ-C30 questionnaire.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until end of follow-up (up to 5 years)
|
|
TTCD in Role Functioning
Time Frame: From randomization until end of follow-up (up to 5 years)
|
TTCD in role functioning (RF) is defined as the time from randomization to the first documentation of ≥10-point decrease in RF score, as determined using the EORTC QLQ-C30 questionnaire.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until end of follow-up (up to 5 years)
|
|
TTCD in Global Health Status/Quality of Life
Time Frame: From randomization until end of follow-up (up to 5 years)
|
TTCD in in Global Health Status/Quality of Life (GHS/QoL) is defined as the time from randomization to the first documentation of ≥10-point decrease in GHS/QoL score, as determined using the EORTC QLQ-C30 questionnaire.
It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.
|
From randomization until end of follow-up (up to 5 years)
|
|
Incidence and Severity of Adverse Events
Time Frame: From Baseline until 28 days after the final dose of study treatment (up to 5 years)
|
Incidence will be reported as the number of participants with at least one adverse event, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0).
|
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
|
|
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Time Frame: From Baseline until 28 days after the final dose of study treatment (up to 5 years)
|
Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature.
|
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
|
|
Number of Participants with Clinical Laboratory Test Abnormalities for Hematology and Biochemistry Parameters Over the Course of the Study
Time Frame: From Baseline until 28 days after the final dose of study treatment (up to 5 years)
|
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
December 11, 2023
Primary Completion (Estimated)
Primary Completion
April 20, 2028
Study Completion (Estimated)
Study Completion
February 12, 2029
Study Registration Dates
First Submitted
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
First Posted
October 4, 2023
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
September 14, 2026
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast 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
- Polycyclic Compounds
- Steroids
- Fused-Ring Compounds
- Estradiol
- Estrenes
- Estranes
- Estradiol Congeners
- Gonadal Steroid Hormones
- Gonadal Hormones
- Fulvestrant
- Gonadotropin-Releasing Hormone
- giredestrant
- abemaciclib
- ribociclib
- palbociclib
Other Study ID Numbers
Other Study ID Numbers
- CO44657
- 2022-502980-39-00 (Registry Identifier: 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
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.