992
Participants
Start Date
October 9, 2020
Primary Completion Date
December 15, 2025
Study Completion Date
March 25, 2028
Giredestrant
Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Giredestrant-matched Placebo
Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Letrozole
Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Letrozole-matched Placebo
Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Palbociclib
Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
LHRH Agonist
Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Oncosalud Sac, Lima
National Taiwan Uni Hospital, Taipei
Mackay Memorial Hospital, Taipei
Chang Gung Memorial Hosipital at Linkou, Taoyuan Hsien
China Medical University Hospital, Taichung
National Cheng Kung Uni Hospital, Tainan City
Organización medica de Investi, Cap Fed
Auckland City Hospital, Auckland
Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály, Budapest
Medizinische Universität Wien, Vienna
Budapesti Uzsoki Utcai Kórház, Budapest
Cliniques Universitaires St-Luc, Brussels
Hospital de Onc Angel Roffo, Buenos Aires
Hospital Provincial del Centenario, Rosario
Calvary Mater Newcastle, Waratah
Herlev Hospital, Herlev
Peter MacCallum Cancer Centre-East Melbourne, Melbourne
Sunshine Hospital, St Albans
Jessa Zkh (Campus Virga Jesse), Hasselt
Mater Hospital Brisbane, South Brisbane
Princess Alexandra Hospital, Woolloongabba
A.Ö. LHK, Steyr
Sjællands Universitetshospital, Næstved, Næstved
Odense Universitetshospital, Onkologisk Afdeling R, Odense C
Uniklinikum Salzburg, LKH, Salzburg
Fiona Stanley Hospital - Medical Oncology, Murdoch
Corporacio Sanitaria Parc Tauli, Sabadell
Korea University Guro Hospital, Seoul
Fondazione del Piemonte per l?Oncologia (IRCCS), Candiolo
Memorial Sloan-Kettering Cancer Center, New York
Chulalongkorn Hospital, Faculty of Medicine, Bangkok
Rajavithi Hospital, Bangkok
Ramathibodi Hospital, Bangkok
National Cancer Center, Gyeonggi-do
MSKCC @ Commack, Commack
Instituto Regional de Enfermedades Neoplasicas - IREN Norte, Trujillo
Ambulantes Tumorzentrum Spandau, Berlin
Seoul National University Bundang Hospital, Gyeonggi-do
Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña
Hospital de Donostia, Donostia / San Sebastian
Istituto Europeo Di Oncologia, Milan
Universitätsklinikum Hamburg-Eppendorf, Hamburg
Facharztzentrum Eppendorf, Studien GbR, Hamburg
Asst Di Monza, Monza
Maryland Oncology Hematology, Silver Spring
Mercy Medical Center, Baltimore
Gachon University Gil Medical Center, Incheon
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne
Inova Fairfax Hospital, Fairfax
Virginia Oncology Associates, Norfolk
Az. Osp. Spedali Civili, Brescia
Hospital General Universitario Gregorio Marañon, Madrid
Centro Oncologico MD Anderson Internacional, Madrid
Hospital Ramon y Cajal, Madrid
Hospital Clinico San Carlos, Madrid
HM Sanchinarro ? CIOCC, Madrid
Hospital Quiron de Madrid, Pozuelo de Alarcón
Chungbuk National University Hospital, Cheongju-si
Roper St. Francis Healthcare, Charleston
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie, Hanover
Kocaeli University Faculty of Medicine, İzmit
SCRI Florida Cancer Specialists PAN, Tallahassee
Memorial Regional Cancer Ctr, Hollywood
University of Miami, Miami
SCRI Florida Cancer Specialists North, St. Petersburg
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers
Medipol University Medical Faculty, Istanbul
Institut régional du Cancer Montpellier, Montpellier
Medeniyet University Goztepe Training and Research Hospital., Istanbul
Centre Eugene Marquis, Rennes
IOV - Istituto Oncologico Veneto - IRCCS, Padua
Katip Celebi University Ataturk Training and Research Hospital, Izmir
Azienda ULSS 8 Berica, Vicenza
Ospedale Sacro Cuore Don Calabria, Negrar
Dres.Andreas Ammon und Dirk Meyer, Göttingen
Sarah Cannon Research Institute / Tennessee Oncology, Nashville
West Cancer Center, Germantown
Sumy Regional Clinical Onc Ctr, Sumy
Hospital Universitario Virgen del Rocio, Seville
Kyungpook National University Medical Center, Daegu
ICL, Saint-Priest-en-Jarez
Ulsan University Hosiptal, Ulsan
The Cleveland Clinic Foundation, Cleveland
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya
Universitätsklinikum Essen, Essen
Hospital Clinico Universitario de Valencia, Valencia
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola
ICO Paul Papin, Angers
Davidof Center - Rabin Medical Center, Petah Tikva
Municipal Institution City Clinical Hospital #4 of Dnipro City Council, Dnipropetrovsk
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council, Kryvyi Rih
Maharaj Nakorn Chiang Mai Hosp, Chang Mai
Institut Jean Godinot, Reims
University of Wisconsin, Madison
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen, Troisdorf
Klinikum Mutterhaus der Borromaeerinnen gGmbH, Trier
Centre Alexis Vautrin, Vandœuvre-lès-Nancy
19 Mayis University Medical Faculty, Samsun
Praxis Köppler, Heymann, Weide, Thomalla, Koblenz
Ospedale Civile - Livorno, Livorno
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Morelia
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU, Kharkiv
Dres. Andreas Köhler und Roswitha Fuchs, Langen
Centre Hospitalier de La Cote Basque, Bayonne
HCA Midwest Division, Kansas City
Filios Alta Medicina, Monterrey
Centro de Investigacion Clinica de Oaxaca, Oaxaca City
Universitätsklinikum Mannheim, Mannheim
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg
Universitätsklinik Tübingen, Tübingen
Texas Oncology - DFW, Dallas
Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth
Baylor St. Luke's Medical Center, Houston
Houston Methodist Hospital, Houston
Oncologico Potosino, San Luis Potosí City
Rocky Mountain Cancer Center, Denver
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt, München
Chd de Vendee, La Roche-sur-Yon
Chu La Miletrie, Poitiers
San Juan Oncology Associates, Farmington
MVZ für Hämatologie und Onkologie Ravensburg GmBH, Ravensburg
Songklanagarind Hospital, Songkhla
Long Beach Memorial Medical Center, Long Beach
Sociedad de Metabolismo y Corazón (SOMECO), Veracruz
Orange Coast Memorial Medical Center, Fountain Valley
Stanford Univ Medical Center, Stanford
Kaiser Permanente - San Leandro Medical Center, San Leandro
Kaiser Permanente - Walnut Creek, Walnut Creek
Humanitas Centro Catanese Di Oncologia, Misterbianco (CT)
Providence Portland Medical Ctr, Portland
Northwest Medical Specialties, Tacoma
Beijing Cancer Hospital, Beijing
Shengjing Hospital of China Medical University, Shenyang
Liaoning cancer Hospital & Institute, Shenyang
"SBIH Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva
The First Hospital of Jilin University, Changchun
Podolsk City Clinical Hospital, Podolsk
Harbin Medical University Cancer Hospital, Harbin
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), Saint Petersburg
the First Affiliated Hospital of Bengbu Medical College, Bengbu
Shandong Cancer Hospital, Jinan
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
Fujian Medical University Union Hospital, Fujian
Ryazan Regional clinical oncology dispensary, Ryazan
Hunan Cancer Hospital, Changsha
Respublikanskiy Onkologicheskiy Dispanser, Saransk
Multidisciplinary clinic Reaviz, Samara
Chelyabinsk region oncology dispensary, Chelyabinsk
Anyang Tumor Hosptial, Anyang
Sun Yat-sen Memorial Hospital, Guangzhou
Sun Yet-sen University Cancer Center, Guangzhou
Guangxi Cancer Hospital of Guangxi Medical University, Nanning
Euromedical General Clinic of Thessaloniki, Thessaloniki
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an
Tel Aviv Sourasky Medical Ctr, Tel Aviv
University of Colorado, Aurora
Kaiser Permanente - Moanalua Medical Center, Honolulu
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge
Astera Cancer Care East Brunswick, East Brunswick
Memorial Sloan Kettering Cancer Center at Bergen, Montvale
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires
Hospital Britanico, Ciudad Autonoma Bs As
Instituto de Oncología de Rosario, Rosario
CEMER Centro Medico de Enfermedades Respiratorias, Vicente López
Hospital Sao Rafael - HSR, Salvador
Hospital Araujo Jorge, Goiânia
Hospital do Cancer de Pernambuco - HCP, Recife
Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Hospital Sao Lucas - PUCRS, Porto Alegre
Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo
Beneficencia Portuguesa de Sao Paulo, São Paulo
Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary
BC Cancer ? Surrey, Surrey
Royal Victoria Regional Health Centre, Barrie
William Osler Health System Brampton Civic Hospital, Brampton
Ottawa Hospital Research Institute, Ottawa
Princess Margaret Cancer Center, Toronto
Universite de Montreal - Hopital Maisonneuve-Rosemont, Montreal
Centre Hospitalier de l?Université de Montréal (CHUM), Montreal
Jewish General Hospital, Montreal
McGill University Health Center, Montreal
Hopital du Saint Sacrement, Québec
Affiliated Hospital of Hebei University, Baoding
Klinikum Chemnitz gGmbH, Chemnitz
"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum, Leipzig
Anticancer Hospital Ag Savas, Athens
Anticancer Hospital Ag. Savas, Athens
European Interbalkan Medical Center, Thessaloniki
Pamela Youde Nethersole Eastern Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Queen Mary Hospital, Hong Kong
Centro Hospitalar Lisboa Norte, Lisbon
Chaim Sheba Medical Center, Ramat Gan
IRCCS Istituto Regina Elena (IFO), Rome
Nagoya University Hospital, Aichi
Chiba Cancer Center, Chiba
National Cancer Center Hospital East, Chiba
National Hospital Organization Kyushu Cancer Center, Fukuoka
Hiroshima City Hiroshima Citizens Hospital, Hiroshima
Hiroshima University Hospital, Hiroshima
National Hospital Organization Hokkaido Cancer Center, Hokkaido
Hyogo Cancer Center, Hyōgo
University of Tsukuba Hospital, Ibaraki
Sagara Hospital, Kagoshima
Kanagawa Cancer Center, Kanagawa
Tokai University Hospital, Kanagawa
Kumamoto University Hospital, Kumamoto
Fukushima Medical University Hospital, Miyagi
Niigata Cancer Center Hospital, Niigata
Naha-nishi Clinic, Okinawa
National Hospital Organization Osaka National Hospital, Osaka
Osaka International Cancer Institute, Osaka
Saitama Cancer Center, Saitama
National Cancer Center Hospital, Tokyo
The Cancer Institute Hospital of JFCR, Tokyo
Showa Medical University Hospital, Tokyo
Health Pharma Professional Research, CD Mexico
Centro Medico Dalinde, Mexico City
Instituto Peruano de Oncología y Radioterapia, Lima
Clinica Ricardo Palma, San Isidro
Instituto Nacional de Enfermedades Neoplasicas, Lima
Uniwersyteckie Centrum Kliniczne, Gda?sk
Szpital Morski im. PCK, Gdynia
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad, Warsaw
IPO de Coimbra, Coimbra
Hospital da Luz, Lisbon
IPO do Porto, Porto
Korea University Anam Hospital, Seoul
Seoul National University Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Gangnam Severance Hospital, Seoul
Samsung Medical Center, Seoul
Hospital Duran i Reynals, L'Hospitalet de Llobregat
Hospital del Mar, Barcelona
Hospital Universitari Dexeus - Grupo Quironsalud, Barcelona
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona
Veterans General Hospital, Taipei
Hacettepe Uni Medical Faculty Hospital, Ankara
Ankara Bilkent City Hospital, Ankara
Royal Sussex County Hospital, Brighton
Leicester Royal Infirmary, Leicester
University College London Hospital, London
Royal Free Hospital, London
Guys & St Thomas Hospital, London
Maidstone Hospital, Maidstone
Peterborough City Hospital, Peterborough
Derriford Hospital, Plymouth
Royal Marsden Hosp NHS Fnd, Sutton
Royal Cornwall Hospital, Truro
Hoffmann-La Roche
INDUSTRY