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 2, 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
Recruiting
Study Type
Interventional
Enrollment (Estimated)
1050
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
- 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
-
-
-
Buenos Aires, Argentina, C1113AAE
- Active, not recruiting
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
-
Buenos Aires, Argentina, C1417DTB
- Active, not recruiting
- Inst. de Oncologia Angel H. Roffo
-
Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
- Active, not recruiting
- Centro Oncologico Korben
-
Córdoba, Argentina, X5000JHQ
- Active, not recruiting
- Sanatorio Allende
-
La Rioja, Argentina, F5300COE
- Active, not recruiting
- Centro Oncologico Riojano Integral (CORI)
-
Recoleta, Argentina, C1118AAT
- Active, not recruiting
- Hospital Alemán
-
Rosario, Argentina, S2000KZE
- Active, not recruiting
- Instituto de Oncología de Rosario
-
Rosario, Argentina, S2000QGB
- Withdrawn
- Sanatorio Parque S.A.
-
Rosario, Argentina, S2002KDS
- Completed
- Hospital Provincial del Centenario
-
San Juan, Argentina, J5400
- Active, not recruiting
- Centro Oncológico de Excelencia
-
-
-
-
New South Wales
-
Frenchs Forest, New South Wales, Australia, 2086
- Active, not recruiting
- Northern Beaches Hospital
-
Kingswood, New South Wales, Australia, 2747
- Active, not recruiting
- Nepean Hospital
-
North Sydney, New South Wales, Australia, 2060
- Active, not recruiting
- Mater Hospital
-
-
Queensland
-
Buderim, Queensland, Australia, 4556
- Active, not recruiting
- Sunshine Coast Haematology and Oncology Clinic
-
South Brisbane, Queensland, Australia, 4101
- Active, not recruiting
- Mater Misericordiae Limited
-
-
South Australia
-
Adelaide, South Australia, Australia
- Recruiting
- Cancer Research SA
-
-
Victoria
-
Geelong, Victoria, Australia, 3220
- Active, not recruiting
- Barwon Health
-
St Albans, Victoria, Australia, 3021
- Active, not recruiting
- Sunshine Hospital
-
Warrnambool, Victoria, Australia, 3280
- Withdrawn
- South West Healthcare
-
-
-
-
-
Graz, Austria, 8036
- Recruiting
- Lkh-Univ. Klinikum Graz
-
Innsbruck, Austria, 6020
- Withdrawn
- Medical University Innsbruck
-
Linz, Austria, 4010
- Recruiting
- Ordensklinikum Linz Barmherzige Schwestern
-
Steyr, Austria, 4400
- Recruiting
- Oö. Gesundheits- und Spitals-AG/LKH Steyr
-
Vienna, Austria, 1090
- Withdrawn
- Medizinische Universität Wien
-
-
-
-
-
Brussels, Belgium, 1200
- Active, not recruiting
- Cliniques Universitaires St-Luc
-
Charleroi, Belgium, 6060
- Withdrawn
- GHdC Site Les Viviers
-
Ghent, Belgium, 9000
- Active, not recruiting
- UZ Gent
-
Leuven, Belgium, 3000
- Active, not recruiting
- UZ Leuven Gasthuisberg
-
Liège, Belgium, 4000
- Active, not recruiting
- CHU de Liège (Sart Tilman)
-
Mechelen, Belgium, 2800
- Withdrawn
- AZ St Maarten Campus Leopoldstr
-
Namur, Belgium, 5000
- Active, not recruiting
- Clinique Ste-Elisabeth
-
Wilrijk, Belgium, 2610
- Active, not recruiting
- ZAS Sint Augustinus Wilrijk
-
-
-
-
-
Rio de Janeiro, Brazil, 22281-100
- Active, not recruiting
- Instituto D'Or de Pesquisa e Ensino
-
-
Ceará
-
Fortaleza, Ceará, Brazil, 60336-232
- Recruiting
- Crio - Centro Regional Integrado de Oncologia
-
-
Espírito Santo
-
Vitória, Espírito Santo, Brazil, 29055-450
- Active, not recruiting
- CEDOES - Diagnóstico e Pesquisa
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brazil, 40415-006
- Recruiting
- Obras Sociais Irma Dulce - Osid
-
-
Federal District
-
Brasília, Federal District, Brazil, 70200-730
- Recruiting
- Hospital Sírio-Libanês
-
-
Goiás
-
Goiânia, Goiás, Brazil, 74605-070
- Active, not recruiting
- Hospital Araujo Jorge
-
-
Maranhão
-
São Luís, Maranhão, Brazil, 65060-645
- Recruiting
- Hospital Sao Domingos
-
-
Paraná
-
Londrina, Paraná, Brazil, 86015-520
- Recruiting
- Hospital do Câncer de Londrina
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50040-000
- Recruiting
- Hospital do Cancer de Pernambuco - HCP
-
-
Piauí
-
Teresina, Piauí, Brazil, 64049-200
- Active, not recruiting
- Vencer Oncoclínica - Centro de Pesquisa do Piauí
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Active, not recruiting
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
-
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Recruiting
- Hospital Sao Lucas - PUCRS
-
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
- Recruiting
- Santa Casa de Misericordia de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
- Active, not recruiting
- Hospital Moinhos de Vento
-
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
- Active, not recruiting
- Hospital Nossa Senhora da Conceicao
-
-
São Paulo
-
Barretos, São Paulo, Brazil, 14784-400
- Recruiting
- Hospital de Cancer de Barretos
-
Jaú, São Paulo, Brazil, 17210-120
- Recruiting
- Hospital Amaral Carvalho
-
São Paulo, São Paulo, Brazil, 01509-010
- Recruiting
- Hospital A. C. Camargo
-
São Paulo, São Paulo, Brazil, 01317-001
- Recruiting
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
-
São Paulo, São Paulo, Brazil, 01308-050
- Recruiting
- Hospital Sírio-Libanês
-
-
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Active, not recruiting
- Cross Cancer Institute
-
-
Ontario
-
Barrie, Ontario, Canada, L4M 6M2
- Active, not recruiting
- Royal Victoria Regional Health Centre
-
Mississauga, Ontario, Canada, L5M 2N1
- Active, not recruiting
- Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
-
Oshawa, Ontario, Canada, L1G 2B9
- Active, not recruiting
- Lakeridge Health Oshawa
-
Thunder Bay, Ontario, Canada, P7B 6V4
- Active, not recruiting
- Thunder Bay Regional Health Sciences Centre
-
Toronto, Ontario, Canada, M5G 2M9
- Active, not recruiting
- Princess Margaret Cancer Center
-
Toronto, Ontario, Canada, M2K 1E1
- Active, not recruiting
- North York General Hospital
-
-
Quebec
-
Chicoutimi, Quebec, Canada, G7H 5H6
- Active, not recruiting
- CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
-
Lévis, Quebec, Canada, G6V 3Z1
- Active, not recruiting
- CISSS Chaudière-Appalaches
-
Montreal, Quebec, Canada, H2X 0C2
- Active, not recruiting
- Centre Hospitalier de l'Université de Montréal (CHUM)
-
Montreal, Quebec, Canada, H4A 3J1
- Withdrawn
- McGill University Health Centre - Glen Site
-
Québec, Quebec, Canada, G1S 4L8
- Active, not recruiting
- CHU de Québec - Hôpital du Saint-Sacrement
-
Saint-Jérôme, Quebec, Canada, J7Z 5T3
- Completed
- Hopital regional de saint jerome
-
Trois-Rivières, Quebec, Canada, G8Z 3R9
- Active, not recruiting
- Centre hospitalier regional de Trois-Rivieres
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Active, not recruiting
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Canada, SK S7N 4H4
- Active, not recruiting
- Saskatoon Cancer Centre
-
-
-
-
-
Las Condes, Chile, 7560908
- Active, not recruiting
- Medicina de Precisión - Celerity
-
Port Montt, Chile, 5500243
- Active, not recruiting
- Clínica Puerto Montt
-
Providencia, Chile, 750000
- Active, not recruiting
- Oncovida
-
Santiago, Chile
- Recruiting
- Icegclinic
-
Santiago, Chile, 8330032
- Active, not recruiting
- Centro De Cancer Universidad Catolica
-
Santiago, Chile, 8380000
- Active, not recruiting
- Instituto Nacional del Cancer
-
-
Región Bio Bio
-
Concepción, Región Bio Bio, Chile, Alto Horno 777
- Active, not recruiting
- Hospital las Higueras
-
-
-
-
-
Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Changchun, China, 130021
- Recruiting
- The First hospital of Jilin University
-
Changsha, China, 410013
- Active, not recruiting
- Hunan Cancer Hospital
-
Chengdu, China, 610041
- Recruiting
- West China Hospital of Sichuan University
-
Chengdu, China, 610072
- Recruiting
- Sichuan Provincial People's Hospital
-
Chongqing, China, 400016
- Withdrawn
- The First Affiliated Hospital, Chongqing Medical University
-
Fuzhou, China, 350001
- Recruiting
- Fujian Medical University Union Hospital
-
Fuzhou, China, 350009
- Recruiting
- No. 900 Hospital (Fuzhou General Hospital)
-
Guangzhou, China, 510060
- Recruiting
- Cancer Center, Sun Yat-sen University of Medical Sciences
-
Hangzhou, China, 310009
- Recruiting
- The Second Affiliated Hospital of Zhejiang University College
-
Harbin, China, 150081
- Recruiting
- Harbin Medical University Cancer Hospital
-
Jinan, China, 250117
- Recruiting
- Shandong Cancer Hospital
-
Jinan, China, 250013
- Active, not recruiting
- Jinan Central Hospital
-
Kunming, China, 650034
- Active, not recruiting
- The First People's Hospital of Yunnan Province
-
Luoyang, China, 471031
- Active, not recruiting
- The First Affiliated Hospital to Henan University of Science and Technology
-
Nanning, China, 530021
- Active, not recruiting
- Guangxi Cancer Hospital of Guangxi Medical University
-
Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital Fudan University
-
Shanghai, China, 200120
- Recruiting
- Fudan University Shanghai Cancer Center
-
Taiyuan, China, 030013
- Recruiting
- Shanxi Province Cancer Hospital
-
Taizhou, China
- Withdrawn
- Taizhou Hospital of Zhejiang Province
-
Tianjin, China
- Recruiting
- Tianjin Cancer Hospital
-
Wuhan, China, 430022
- Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Wuhan, China, 430079
- Recruiting
- Hubei Cancer Hospital
-
Xi'an, China, 710100
- Recruiting
- Xi'an International Medical Center Hospital
-
Xi'an, China, 710004
- Recruiting
- The Second Affiliated Hospital of Xi'an Jiao Tong University
-
Xuzhou, China
- Recruiting
- The Affiliated Hospital of Xuzhou Medical University
-
Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Zhengzhou, China, 450052
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Ürümqi, China, 830000
- Recruiting
- The Tumor Hospital of Xinjiang Medical University
-
-
-
-
-
Bogota, D.C., Colombia, 110131
- Recruiting
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
-
Bogotá D.C., Colombia, 51000
- Recruiting
- Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
-
Cali, Colombia
- Recruiting
- IPS Salud SURA Chipichape Cali
-
Montería, Colombia, 230002
- Recruiting
- Oncomedica S.A.
-
Valledupar, Colombia, 200001
- Recruiting
- Sociedad de Oncología y hematología del Cesar Ltda
-
-
-
-
-
San José, Costa Rica, 10103
- Active, not recruiting
- Clinica CIMCA
-
San José, Costa Rica, 10108
- Active, not recruiting
- ICIMED Instituto de Investigación en Ciencias Médicas
-
San José, Costa Rica, 11303
- Withdrawn
- Proclinical Pharma
-
-
-
-
-
Kuopio, Finland, 70211
- Withdrawn
- Kuopio Uni Hospital
-
Tampere, Finland, 33520
- Active, not recruiting
- Tampere University Hospital
-
-
-
-
-
Angers, France, 49055
- Active, not recruiting
- ICO Paul Papin
-
Avignon, France, 84918
- Active, not recruiting
- Institut Sainte Catherine
-
Besançon, France, 25030
- Completed
- Hopital Jean Minjoz
-
Caen, France, 14076
- Active, not recruiting
- Centre Francois Baclesse
-
Clermont-Ferrand, France, 63011
- Active, not recruiting
- Centre Jean Perrin
-
La Rochelle, France, 17019
- Active, not recruiting
- Centre Hospitalier Saint Louis
-
Lille, France, 59020
- Active, not recruiting
- Centre Oscar Lambret
-
Lyon, France, 69373
- Active, not recruiting
- Centre Léon Bérard
-
Montpellier, France, 34070
- Active, not recruiting
- Centre Cancerologie Grand Montpellier
-
Reims, France, 51056
- Active, not recruiting
- Institut Jean Godinot
-
Rennes, France, 35042
- Active, not recruiting
- Centre Eugène Marquis
-
Toulouse, France, 31100
- Active, not recruiting
- IUCT Oncopole
-
Villejuif, France, 94805
- Active, not recruiting
- Gustave Roussy
-
-
-
-
-
Bamberg, Germany, 96049
- Active, not recruiting
- Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
-
Cologne, Germany, 50935
- Active, not recruiting
- St. Elisabeth Krankenhaus Köln GmbH
-
Deggendorf, Germany, 94469
- Withdrawn
- DONAU ISAR Klinikum Deggendorf
-
Düsseldorf, Germany, 40235
- Completed
- Gynonco Düsseldorf, MVZ Medical Center GmbH
-
Erlangen, Germany, 91054
- Active, not recruiting
- Universitätsklinikum Erlangen
-
Essen, Germany, 45136
- Active, not recruiting
- Kliniken Essen-Mitte
-
Freiburg im Breisgau, Germany, 79110
- Active, not recruiting
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
-
Heidelberg, Germany, 69120
- Active, not recruiting
- Nationales Centrum für Tumorerkrankungen (NCT)
-
Homburg/Saar, Germany, 66424
- Active, not recruiting
- Universitätsklinikum des Saarlandes
-
Mönchengladbach, Germany, 41061
- Active, not recruiting
- Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
-
München, Germany, 80637
- Active, not recruiting
- Rotkreuzklinikum München
-
-
-
-
-
Athens, Greece, 115 22
- Active, not recruiting
- Anticancer Hospital Ag. Savas
-
Athens, Greece, 115 28
- Active, not recruiting
- Aretaieio Hospital of Athens
-
Larissa, Greece, 411 10
- Recruiting
- University Hospital of Larissa
-
Pátrai, Greece, 265 04
- Recruiting
- University Hospital of Patras Medical Oncology
-
Thessaloniki, Greece, 570 01
- Recruiting
- European Interbalkan Medical Center
-
-
-
-
-
Guatemala City, Guatemala, 01015
- Active, not recruiting
- Grupo Angeles
-
Guatemala City, Guatemala, 01009
- Active, not recruiting
- Oncomedica
-
Guatemala City, Guatemala, 01010
- Active, not recruiting
- Celan S.A.
-
Guatemala City, Guatemala, 01010
- Active, not recruiting
- INTEGRA Cancer Institute
-
Guatemala City, Guatemala, 01010
- Active, not recruiting
- Onco Go, S.A.
-
Guatemala City, Guatemala, 01016
- Active, not recruiting
- Medi-k
-
Salcajá, Guatemala, 09002
- Active, not recruiting
- Centro Medico Integral de Cancerologia CEMIC
-
-
-
-
-
Hong Kong, Hong Kong
- Active, not recruiting
- Queen Mary Hospital
-
Hong Kong, Hong Kong
- Active, not recruiting
- Pamela Youde Nethersole Eastern Hospital
-
-
-
-
-
Budapest, Hungary, 1122
- Completed
- Orszagos Onkologiai Intezet
-
Kecskemét, Hungary, 6000
- Completed
- Bács-Kiskun Vármegyei Oktatókórház
-
Miskolc, Hungary, 3526
- Active, not recruiting
- B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház
-
Salgótarján, Hungary, 3100
- Active, not recruiting
- Nograd Varmegyei Szent Lazar Korhaz
-
-
-
-
Karnataka
-
Banglore, Karnataka, India, 560027
- Recruiting
- HealthCare Global Enterprises Limited
-
-
Kerala
-
Kozhikode, Kerala, India, 673601
- Recruiting
- MVR Cancer Centre and Research Institute
-
Trivandrum, Kerala, India, 695011
- Recruiting
- Regional Cancer Centre
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400004
- Recruiting
- Sir H. N. Reliance Foundation Hospital and Research Centre
-
Pune, Maharashtra, India, 411004
- Recruiting
- Sahyadri Super Speciality Hospital
-
Pune, Maharashtra, India, 411001
- Recruiting
- Grant Medical Foundation, Ruby Hall Clinic
-
Thane, Maharashtra, India, 400615
- Recruiting
- Sunact Cancer Institute
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, India, 110017
- Withdrawn
- Max Super Speciality Hospital
-
-
-
-
-
Jerusalem, Israel, 9112000
- Recruiting
- Hadassah Ein Karem Hospital
-
Petah Tikva, Israel, 4910000
- Recruiting
- Rabin Medical Center
-
Ramat Gan, Israel, 5265601
- Recruiting
- Sheba MC
-
Tel Aviv, Israel, 6423900
- Recruiting
- Sourasky Medical Center
-
-
-
-
Apulia
-
Brindisi, Apulia, Italy, 72100
- Active, not recruiting
- Presidio Ospedaliero di Summa-Perrino
-
-
Campania
-
Avellino, Campania, Italy, 83100
- Active, not recruiting
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
-
Naples, Campania, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
-
Naples, Campania, Italy, 80131
- Completed
- Azienda Ospedaliera Universitaria Federico II
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Italy, 40138
- Active, not recruiting
- Policlinico S.Orsola-Malpighi
-
Meldola, Emilia-Romagna, Italy, 47014
- Active, not recruiting
- I.R.S.T Srl IRCCS
-
Parma, Emilia-Romagna, Italy, 43100
- Active, not recruiting
- A.O. Universitaria Di Parma
-
-
Friuli Venezia Giulia
-
Aviano (PN), Friuli Venezia Giulia, Italy, 33081
- Active, not recruiting
- RCCS - Centro di Riferimento
-
Udine, Friuli Venezia Giulia, Italy, 33100
- Active, not recruiting
- A.O. Universitaria S. Maria Della Misericordia Di Udine
-
-
Lazio
-
Rome, Lazio, Italy, 00168
- Active, not recruiting
- Policlinico Universitario Agostino Gemelli
-
Rome, Lazio, Italy, 128
- Active, not recruiting
- Università Campus Bio-Medico di Roma
-
-
Lombardy
-
Bergamo, Lombardy, Italy, 24127
- Active, not recruiting
- Asst Papa Giovanni XXIII
-
Brescia, Lombardy, Italy, 25123
- Active, not recruiting
- Asst Degli Spedali Civili Di Brescia
-
Cremona, Lombardy, Italy, 26100
- Active, not recruiting
- Asst Di Cremona
-
Milan, Lombardy, Italy, 20133
- Active, not recruiting
- Irccs Istituto Nazionale Dei Tumori (Int)
-
Rozzano, Lombardy, Italy, 20089
- Active, not recruiting
- Istituto Clinico Humanitas
-
-
Piedmont
-
Novara, Piedmont, Italy, 28100
- Active, not recruiting
- A.O.U. Maggiore della Carità
-
-
Sicily
-
Misterbianco (CT), Sicily, Italy, 95045
- Active, not recruiting
- Humanitas Centro Catanese Di Oncologia
-
-
The Marches
-
Province of Macerata, The Marches, Italy, 62100
- Active, not recruiting
- Ospedale Di Macerata
-
-
Tuscany
-
Florence, Tuscany, Italy, 50134
- Active, not recruiting
- Azienda Ospedaliera Universitaria Careggi
-
-
Veneto
-
Padova, Veneto, Italy, 35128
- Active, not recruiting
- IOV - Istituto Oncologico Veneto - IRCCS
-
-
-
-
-
Nairobi, Kenya
- Recruiting
- University of Nairobi - Institute of Tropical and Infectious Diseases
-
-
-
-
-
Mexico City, Mexico, 03100
- Recruiting
- CENEIT Oncologicos
-
Mexico City, Mexico, 04010
- Recruiting
- Clinica Alivia sucursal Coyoacan
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44670
- Recruiting
- Panamerican Clinical Research S.A de C.V.
-
Guadalajara, Jalisco, Mexico, 44680
- Recruiting
- RENATI INNOVATION S.A.P.I. de C.V
-
-
Mexico CITY (federal District)
-
Mexico City, Mexico CITY (federal District), Mexico, 03240
- Recruiting
- Productos y Servicios Oncologicos Acacias SA de CV
-
Mexico City, Mexico CITY (federal District), Mexico, 06760
- Active, not recruiting
- Centro de Atencion Oncologica Viva S de RL de CV
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico
- Recruiting
- Hospital Zambrano Hellion TecSalud
-
-
Oaxaca
-
Oaxaca City, Oaxaca, Mexico, 68020
- Recruiting
- Centro de Investigacion Clinica de Oaxaca
-
-
Querétaro
-
Queréaro, Querétaro, Mexico, 76230
- Active, not recruiting
- PanAmerican Clinical Research, Querétaro
-
-
-
-
-
Christchurch, New Zealand
- Recruiting
- Christchurch Hospital
-
Palmerston North, New Zealand, 4442
- Recruiting
- Palmerston North Hospital
-
Whangarei, New Zealand, 0110
- Active, not recruiting
- Whangarei Hospital
-
-
-
-
-
Arequipa, Peru, 04001
- Active, not recruiting
- Centro Medico Monte Carmelo
-
Arequipa, Peru, 5154
- Recruiting
- Hospital Goyeneche
-
Lima, Peru, Lima 34
- Active, not recruiting
- Instituto Nacional de Enfermedades Neoplasicas
-
Lima, Peru
- Recruiting
- Instituto Peruano de Oncología y Radioterapia
-
Lima, Peru, 41
- Active, not recruiting
- Oncosalud Sac
-
Lima, Peru, 15072
- Completed
- Clínica Santa Beatriz
-
Lima, Peru, Lima 41
- Active, not recruiting
- Clinica Internacional, Sede San Borja
-
Lima, Peru, 1
- Active, not recruiting
- Hospital Nacional Arzobispo Loayza
-
Trujillo, Peru, 13011
- Withdrawn
- Clinica Peruana Americana
-
Trujillo, Peru, 13014
- Withdrawn
- Instituto Regional de Enfermedades Neoplasicas - IREN Norte
-
Trujillo, Peru, 13008
- Active, not recruiting
- Clinica San Antonio;Investigaciones Trujillo S.A.C.
-
-
-
-
-
?ód?, Poland, 93-338
- Recruiting
- Instytut "Centrum Zdrowia Matki Polki"
-
Bydgoszcz, Poland, 85-796
- Recruiting
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
-
Gdynia, Poland, 81-519
- Recruiting
- Szpital Morski Im. Pck
-
Gliwice, Poland, 44-102
- Recruiting
- Narodowy Instytut Onkologii Odzia? w Gliwicach
-
Kielce, Poland, 25-734
- Recruiting
- ?wi?tokrzyskie Centrum Onkologii
-
Konin, Poland, 62-500
- Recruiting
- Przychodnia Lekarska KOMED, Roman Karaszewski
-
Koszalin, Poland, 75-581
- Recruiting
- Szpital Wojewódzki im. Miko?aja Kopernika
-
Lublin, Poland, 20-090
- Recruiting
- Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
-
Opole, Poland, 45-061
- Withdrawn
- Opolskie Centrum Onkologii
-
Siedlce, Poland, 08-110
- Recruiting
- Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II
-
Szczecin, Poland, 71-730
- Recruiting
- Zachodniopomorskie Centrum Onkologii
-
Warsaw, Poland, 02-781
- Recruiting
- Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
-
-
-
-
-
Coimbra, Portugal, 3000-075
- Active, not recruiting
- IPO de Coimbra
-
Lisbon, Portugal, 1500-650
- Active, not recruiting
- Hospital da Luz
-
Lisbon, Portugal, 1495-005
- Active, not recruiting
- Hospital de S. Francisco Xavier
-
Porto, Portugal, 4200-072
- Active, not recruiting
- IPO do Porto
-
Vila Nova de Gaia, Portugal, 4434-502
- Active, not recruiting
- CHVNG/E_Unidade 1
-
-
-
-
-
San Juan, Puerto Rico, 00935
- Recruiting
- PanOncology Trials
-
-
-
-
-
Bucharest, Romania, 022328
- Recruiting
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
-
Bucharest, Romania, 011171
- Active, not recruiting
- Spitalul Clinic Filantropia
-
Cluj County, Romania, 407280
- Withdrawn
- Amethyst Cluj
-
Cluj-Napoca, Romania, 400015
- Recruiting
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
-
Craiova, Romania, 200347
- Withdrawn
- Centrul de Oncologie Sfantul Nectarie
-
Iași, Romania, 700483
- Recruiting
- Institutul Regional de Oncologie Iasi
-
Timișoara, Romania, 300239
- Active, not recruiting
- Centrul de Oncologie Oncohelp
-
-
-
-
-
Singapore, Singapore, 119228
- Active, not recruiting
- National University Hospital
-
Singapore, Singapore, 168583
- Active, not recruiting
- National Cancer Centre
-
Singapore, Singapore, 258499
- Withdrawn
- Icon Cancer Centre Gleneagles
-
-
-
-
-
Ljubljana, Slovenia, 1000
- Active, not recruiting
- Institute of Oncology Ljubljana
-
-
-
-
-
Cape Town, South Africa, 7700
- Withdrawn
- Cancercare Rondebosch Oncology
-
Port Elizabeth, South Africa, 6045
- Recruiting
- Cancercare
-
Pretoria, South Africa, 0002
- Recruiting
- Steve Biko Academic Hospital
-
Soweto, South Africa, 2013
- Recruiting
- Wits Clinical Research
-
-
-
-
-
Daegu, South Korea, 41404
- Active, not recruiting
- Kyungpook National University Chilgok Hospital
-
Seongnam-si, South Korea, 13620
- Active, not recruiting
- Seoul National University Bundang Hospital
-
Seoul, South Korea, 03080
- Active, not recruiting
- Seoul National University Hospital
-
Seoul, South Korea, 05505
- Active, not recruiting
- Asan Medical Center
-
Seoul, South Korea, 135-710
- Active, not recruiting
- Samsung Medical Center
-
Seoul, South Korea, 03722
- Active, not recruiting
- Severance Hospital, Yonsei University Health System
-
Seoul, South Korea, 06273
- Active, not recruiting
- Gangnam Severance Hospital
-
Seoul, South Korea, 02841
- Completed
- Korea University Anam Hospital
-
Seoul, South Korea, 07985
- Active, not recruiting
- Ewha Womans University Mokdong Hospital
-
Ulsan, South Korea, 44033
- Active, not recruiting
- Ulsan University Hosiptal
-
-
-
-
-
Barcelona, Spain, 08035
- Active, not recruiting
- Hospital Universitari Vall d'Hebron
-
Barcelona, Spain, 08028
- Recruiting
- Hospital Universitari Dexeus - Grupo Quironsalud
-
Huelva, Spain, 21005
- Recruiting
- Hospital Juan Ramon Jimenez
-
Jaén, Spain, 23007
- Recruiting
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
-
Madrid, Spain, 28050
- Recruiting
- Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
-
Madrid, Spain, 28033
- Active, not recruiting
- Centro Oncologico MD Anderson Internacional
-
Seville, Spain, 41013
- Active, not recruiting
- Hospital Universitario Virgen del Rocio
-
Seville, Spain, 41009
- Active, not recruiting
- Hospital Universitario Virgen Macarena
-
Valencia, Spain, 46015
- Recruiting
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
-
Valencia, Spain, 46009
- Recruiting
- Instituto Valenciano Oncologia
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Recruiting
- Institut Catala d?Oncologia Hospital Germans Trias i Pujol
-
-
Cadiz
-
Jerez de la Frontera, Cadiz, Spain, 11407
- Recruiting
- Hospital de Jerez de la Frontera
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spain, 28223
- Recruiting
- Hospital Quiron de Madrid
-
-
Murcia
-
EL Palmar (EL Palmar), Murcia, Spain, 30120
- Active, not recruiting
- Hospital Universitario Virgen de La Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, Spain, 36213
- Active, not recruiting
- Hospital Alvaro Cunqueiro
-
-
-
-
-
Hsinchu, Taiwan, 300
- Active, not recruiting
- Hsin-Chu Branch of National Taiwan University Hospital
-
Taichung, Taiwan, 404
- Active, not recruiting
- China Medical University Hospital
-
Taipei, Taiwan, 100
- Active, not recruiting
- National Taiwan Uni Hospital
-
Taipei, Taiwan, 00112
- Active, not recruiting
- Veterans General Hospital
-
Taipei, Taiwan, 11259
- Active, not recruiting
- Koo Foundation Sun Yat-Sen Cancer Center
-
Xitun Dist., Taiwan, 40705
- Active, not recruiting
- Veterans General Hospital - Taichung
-
-
-
-
-
Bangkok, Thailand, 10400
- Recruiting
- Rajavithi Hospital
-
Bangkok, Thailand, 10330
- Recruiting
- Chulalongkorn Hospital
-
Bangkok, Thailand, 10400
- Recruiting
- National Cancer Institute
-
Lak Si, Thailand, 10210
- Recruiting
- Chulabhorn Hospital
-
Muang Chiang MAI Delivery Branch 3, Thailand, 50200
- Recruiting
- Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology
-
Songkhla, Thailand, 90110
- Recruiting
- Songklanagarind Hospital
-
-
-
-
-
Adapazarı, Turkey (Türkiye), 54290
- Active, not recruiting
- Sakarya Training and Research Hospital
-
Ankara, Turkey (Türkiye), 06800
- Active, not recruiting
- Ankara City Hospital
-
Bakirkoy / Istanbul, Turkey (Türkiye), 34147
- Active, not recruiting
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
-
Izmir, Turkey (Türkiye), 35360
- Active, not recruiting
- Izmir Ataturk Training and Research Hospital
-
Kadiköy, Turkey (Türkiye), 34722
- Active, not recruiting
- Goztepe Prof.Dr. Suleyman Yalcin City Hospital
-
Mersin, Turkey (Türkiye), 33240
- Active, not recruiting
- Mersin City Education and Research Hospital
-
Samsun, Turkey (Türkiye), 55200
- Active, not recruiting
- Medikal Park Samsun
-
Sihhiye/Ankara, Turkey (Türkiye), 06230
- Active, not recruiting
- Hacettepe Uni Medical Faculty Hospital
-
-
-
-
Alabama
-
Daphne, Alabama, United States, 36526
- Recruiting
- Southern Cancer Center
-
-
California
-
Auburn, California, United States, 95602
- Withdrawn
- Sutter Auburn Faith Hospital
-
Greenbrae, California, United States, 94904
- Active, not recruiting
- Marin Cancer Care Inc
-
Harbor City, California, United States, 90710
- Active, not recruiting
- Kaiser Permanente - Harbor City
-
Los Angeles, California, United States, 90033
- Recruiting
- USC Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90017
- Active, not recruiting
- Oncura Health
-
Newport Beach, California, United States, 92663
- Withdrawn
- USC Norris Cancer Center
-
Roseville, California, United States, 95661
- Withdrawn
- Sutter Medical Group, Roseville Clinic
-
Sacramento, California, United States, 95816
- Withdrawn
- Sutter Health Medical Center
-
Torrance, California, United States, 90502
- Active, not recruiting
- The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
-
-
Colorado
-
Littleton, Colorado, United States, 80120-4413
- Active, not recruiting
- Rocky Mountain Cancer Centers
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Active, not recruiting
- Georgetown University Medical Center
-
Washington D.C., District of Columbia, United States, 20010
- Active, not recruiting
- MedStar Washington Hosp Center
-
-
Florida
-
Altamonte Springs, Florida, United States, 32701
- Active, not recruiting
- AdventHealth Altamonte
-
Fort Myers, Florida, United States, 33901
- Recruiting
- Florida Cancer Specialists - Broadway
-
Jacksonville, Florida, United States, 32256
- Active, not recruiting
- Cancer Specialists of North Florida
-
St. Petersburg, Florida, United States, 33701-4553
- Recruiting
- Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
-
St. Petersburg, Florida, United States, 33709
- Active, not recruiting
- Comprehensive Hematology Oncology
-
West Palm Beach, Florida, United States, 33401-3406
- Recruiting
- Florida Cancer Specialists - EAST - SCRI - PPDS
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Active, not recruiting
- Winship Cancer Institute of Emory University
-
Atlanta, Georgia, United States, 30303
- Withdrawn
- Grady Health System
-
-
Illinois
-
Park Ridge, Illinois, United States, 60068
- Withdrawn
- Advocate Lutheran General Hospital
-
Springfield, Illinois, United States, 62702
- Withdrawn
- Springfield Clinic
-
-
Iowa
-
Des Moines, Iowa, United States, 50309
- Withdrawn
- Mission Cancer + Blood - IMMC
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- Withdrawn
- Baptist Health Lexington
-
Lexington, Kentucky, United States, 40509
- Withdrawn
- Baptist Health Hamburg
-
Louisville, Kentucky, United States, 40207
- Completed
- Baptist Health Louisville
-
-
Maine
-
Scarborough, Maine, United States, 04074
- Active, not recruiting
- New England Cancer Specialists
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Recruiting
- Maryland Oncology Hematology
-
Frederick, Maryland, United States, 21702
- Withdrawn
- Frederick Health Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Active, not recruiting
- Dana Farber Cancer Institute
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Active, not recruiting
- Henry Ford Hospital
-
-
Missouri
-
Kansas City, Missouri, United States, 64132
- Active, not recruiting
- HCA Midwest Division
-
O'Fallon, Missouri, United States, 62269
- Withdrawn
- Cancer Care Center of O'Fallon
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Active, not recruiting
- Oncology Hematology West - Grand Island
-
Omaha, Nebraska, United States, 68130-2042
- Active, not recruiting
- Oncology Hematology West - Legacy
-
-
New Jersey
-
East Brunswick, New Jersey, United States, 08816
- Active, not recruiting
- Astera Cancer Care East Brunswick
-
Pennington, New Jersey, United States, 08534
- Withdrawn
- Capital Health Regional Medical Center
-
-
New York
-
Jamaica, New York, United States, 11432
- Withdrawn
- Queens Hospital Cancer Center
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27607
- Recruiting
- Duke Women Cancer Care
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Withdrawn
- Oncology Hematology Care
-
-
Oregon
-
Medford, Oregon, United States, 97504-8332
- Recruiting
- Asante Rogue Regional Medical Center
-
-
Pennsylvania
-
Bensalem, Pennsylvania, United States, 19020
- Recruiting
- Alliance Cancer Specialists
-
Lancaster, Pennsylvania, United States, 17604
- Active, not recruiting
- Ann B. Barshinger Cancer Institute
-
Philadelphia, Pennsylvania, United States, 19106
- Recruiting
- Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
-
York, Pennsylvania, United States, 17403
- Withdrawn
- WellSpan Oncology Research
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Active, not recruiting
- Brown University Health
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Withdrawn
- Medical University of South Carolina
-
-
South Dakota
-
Aberdeen, South Dakota, United States, 57401
- Withdrawn
- Avera Cancer Institute - Aberdeen
-
Sioux Falls, South Dakota, United States, 57105
- Recruiting
- Avera Cancer Institute
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Recruiting
- West Cancer Center
-
Nashville, Tennessee, United States, 37203
- Active, not recruiting
- SCRI Oncology Partners
-
-
Texas
-
Austin, Texas, United States, 78731
- Active, not recruiting
- Texas Oncology Cancer Center
-
Fort Worth, Texas, United States, 76104
- Withdrawn
- JPS Oncology & Infusion Center
-
Irving, Texas, United States, 75063
- Completed
- Texas Oncology - DFW
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Active, not recruiting
- Virginia Cancer Specialists, PC
-
Richmond, Virginia, United States, 23219
- Active, not recruiting
- Virginia Commonwealth University - Massey Cancer Center
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Active, not recruiting
- Northwest Medical Specialties
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26056
- Active, not recruiting
- West Virginia University Hospitals Inc
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54311
- Withdrawn
- Aurora BayCare Medical Center
-
Milwaukee, Wisconsin, United States, 53215
- Withdrawn
- Aurora St Lukes Medical Center
-
-
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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
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
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)
December 11, 2023
Primary Completion (Estimated)
February 19, 2027
Study Completion (Estimated)
February 12, 2029
Study Registration Dates
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
October 4, 2023
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
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
- 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.