450
Participants
Start Date
April 9, 2025
Primary Completion Date
January 29, 2028
Study Completion Date
May 30, 2032
Inavolisib
Participants will receive oral inavolisib once daily (QD).
Placebo
Participants will receive oral placebo QD.
CDK4/6i
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Letrozole
Participants will receive oral letrozole QD.
RECRUITING
National Taiwan Uni Hospital, Taipei
RECRUITING
National Cheng Kung Uni Hospital, Tainan City
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Wits Clinical Research, Soweto
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Royal North Shore Hospital, St Leonards
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Linksfield Oncology Inc., Johannesburg
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Abraham Oncology, Richards Bay
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Lyell McEwin Hospital, Elizabeth Vale
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National Cancer Center, Goyang-si
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Instituto Nacional De Cancerologia, Distrito Federal
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Istituto Clinico Humanitas, Rozzano
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Ospedale San Raffaele, Milan
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Irccs Istituto Nazionale Dei Tumori (Int), Milan
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Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg
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Velocity Clinical Research, Annapolis
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Centre CARIO - HPCA, Plérin
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Asst Papa Giovanni XXIII, Bergamo
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IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica, Madrid
RECRUITING
Hospital Clínico San Carlos, Madrid
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Hospital Universitario 12 de Octubre, Madrid
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University of Eastern Piedmont - Maggiore della Carità University Hospital, Novara
RECRUITING
Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia, Málaga
RECRUITING
Northwest Georgia Oncology Centers PC - Marietta, Marietta
RECRUITING
Centro Estatal de Cancerologia de Chihuahua, Chihuahua City
RECRUITING
Hospital de Navarra, Pamplona
RECRUITING
Institut Universitaire de Cancer de Toulouse Oncopole, Toulouse
RECRUITING
Soon Chun Hyang University Cheonan Hospital, Dongnam-gu, Cheonan-si
RECRUITING
Mersin City Education and Research Hospital, Mersin
RECRUITING
Centre Cancerologie Grand Montpellier, Montpellier
RECRUITING
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul
RECRUITING
Ba?c?lar Medipol Mega Üniversite Hastanesi, Istanbul
RECRUITING
Centre Eugene Marquis, Rennes
RECRUITING
Katip Celebi University Ataturk Training and Research Hospital, Izmir
RECRUITING
West Cancer Center, Germantown
RECRUITING
Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic, Bolzano
RECRUITING
Policlinico S.Orsola-Malpighi, Bologna
RECRUITING
Baptist Health Louisville, Louisville
RECRUITING
Baptist Health Lexington, Lexington
RECRUITING
Baptist Health Hamburg, Lexington
RECRUITING
A.O. Universitaria Policlinico Di Modena, Modena
RECRUITING
Kyungpook National University Chilgok Hospital, Daegu
RECRUITING
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara
RECRUITING
Cleveland Clinic Foundation, Cleveland
RECRUITING
Universitätsklinikum Essen, Essen
RECRUITING
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH, Essen
RECRUITING
Hospital Clinico Universitario de Valencia, Valencia
RECRUITING
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola
RECRUITING
Hospital de Basurto, Bilbao
RECRUITING
Universitätsklinikum Münster, Münster
RECRUITING
Cancer & Hematology Centers of Western Michigan, Grand Rapids
RECRUITING
St. Elisabeth Krankenhaus Köln GmbH, Cologne
RECRUITING
InVO - Institut für Versorgungsforschung in der Onkologie GbR, Koblenz
RECRUITING
Ospedale Civile - Livorno, Livorno
RECRUITING
Carle Cancer Center, Urbana
RECRUITING
Cancer Care Specialists of Central Illinois, O'Fallon
RECRUITING
Springfield Clinic, Springfield
RECRUITING
Dres. Andreas Köhler und Roswitha Fuchs, Langen
RECRUITING
HCA Midwest Health, Kansas City
RECRUITING
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum, Saarbrücken
RECRUITING
Centro de Investigacion Clinica de Oaxaca, Oaxaca City
RECRUITING
Nebraska Cancer Specialists, Grand Island
RECRUITING
Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V., Ciudad de Huajuapan de León
RECRUITING
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg
RECRUITING
Az. Osp. G. Panico, Tricase (LE)
RECRUITING
A.O. Universitaria Federico II Di Napoli, Napoli
RECRUITING
U.O.C. Oncologia Medica Senologica, Napoli
RECRUITING
A.O. S. Anna e San Sebastiano, Caserta
RECRUITING
Kaiser Permanente - San Marcos, San Marcos
RECRUITING
Caritas-Krankenhaus St. Josef, Regensburg
RECRUITING
Humanitas Centro Catanese Di Oncologia, Misterbianco (CT)
RECRUITING
Providence Portland Medical Center, Portland
RECRUITING
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy, Portland
RECRUITING
Swedish Cancer Institute - Edmonds Campus, Edmonds
RECRUITING
Swedish Cancer Institute - Issaquah, Seattle
RECRUITING
Swedish Cancer Institute, Seattle
RECRUITING
Northwest Medical Specialties, Tacoma
RECRUITING
Peking Union Medical College Hospital, Beijing
RECRUITING
Koo Foundation Sun Yat-Sen Cancer Center, Taipei
RECRUITING
Taipei Veterans General Hospital, Taipei
RECRUITING
Harbin Medical University Cancer Hospital, Harbin
RECRUITING
Shandong Cancer Hospital, Jinan
RECRUITING
Tianjin Cancer Hospital, Tianjin
RECRUITING
Tianjin Cancer hospital Airport hospital, Tianjin
RECRUITING
Zhejiang Cancer Hospital, Hangzhou
RECRUITING
Jinhua municipal central hospital, Jinhua
RECRUITING
Taichung Veterans General Hospital, Taichung
RECRUITING
Hunan Cancer Hospital, Changsha
RECRUITING
Xiangyang Central Hospital, Xiangyang
RECRUITING
Sun yat-sen University Cancer Center, Guangzhou
RECRUITING
Shantou Center Hospital, Shantou
RECRUITING
Jiangmen Central Hospital, Jiangmen
RECRUITING
Guangxi Cancer Hospital of Guangxi Medical University, Nanning
RECRUITING
Chia-Yi Christian Hospital, Chiayi City
RECRUITING
West China Hospital of Sichuan University, Chengdu
RECRUITING
Sichuan Provincial People's Hospital, Chengdu
RECRUITING
Yunnan Cancer Hospital, Kunming
RECRUITING
The Second Affiliated Hospital of Xi'an Jiao Tong University, Xi'an
RECRUITING
Shanxi Provincial People's Hospital, Xi'an
RECRUITING
Xinjiang Medical University Cancer Hospital, Ürümqi
RECRUITING
Nebraska Cancer Specialists, Omaha
RECRUITING
Astera Cancer Care East Brunswick, East Brunswick
RECRUITING
Centro Oncologico Korben, Caba
RECRUITING
Centro Médico Fleischer, Capital Federal
RECRUITING
Hospital Privado Centro Medico de Cordoba, Córdoba
RECRUITING
Instituto de Oncologia de Rosario, Rosario
RECRUITING
Centro Oncológico de Excelencia, San Juan
RECRUITING
Crio - Centro Regional Integrado de Oncologia, Fortaleza
RECRUITING
Hospital Santa Rita de Cassia Vitoria, Vitória
RECRUITING
Obras Sociais Irma Dulce - Osid, Salvador
RECRUITING
Hospital Araujo Jorge, Goiânia
RECRUITING
Centro de Oncologia de Alfenas, Alfenas
RECRUITING
Hospital do Câncer de Londrina, Londrina
RECRUITING
Hospital do Cancer de Pernambuco - HCP, Recife
RECRUITING
Vencer Oncoclínica - Centro de Pesquisa do Piauí, Teresina
RECRUITING
Santa Casa de Misericordia de Porto Alegre, Porto Alegre
RECRUITING
Hospital de Cancer de Barretos, Barretos
RECRUITING
Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo
RECRUITING
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo
RECRUITING
Instituto Nacional de Cancer - INCa, Rio de Janeiro
RECRUITING
The Moncton Hospital, Moncton
RECRUITING
The Ottawa Hospital Cancer Center, Ottawa
RECRUITING
St. Joseph's Health Centre, Toronto
RECRUITING
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal
RECRUITING
Jewish General Hospital, Montreal
RECRUITING
Unité de Recherche Clinique du CISSS de Laurentides, Saint-Jérôme
RECRUITING
Sun Yat-Sen University Cancer Center - Huangpu Campus, Guangzhou
RECRUITING
Hospital Zambrano Hellion TecSalud, Monterrey
RECRUITING
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
RECRUITING
A.O. Santa Maria Terni, Terni
RECRUITING
Iem-Fucam, D.F.
RECRUITING
"Instytut Centrum Zdrowia Matki Polki", ?ód?
RECRUITING
Bialostockie Centrum Onkologii, Bialystok
RECRUITING
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin
RECRUITING
Szpital Wojewódzki im. Miko?aja Kopernika, Koszalin
RECRUITING
Szpital Miejski Specjalistyczny Narutowicza, Krakow
RECRUITING
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin
RECRUITING
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie, Późna
RECRUITING
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów
RECRUITING
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad, Warsaw
RECRUITING
PanOncology Trials, San Juan
RECRUITING
Seoul National University Bundang Hospital, Seongnam-si
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Severance Hospital, Yonsei University Health System, Seoul
RECRUITING
Asan Medical Center, Seoul
RECRUITING
Gangnam Severance Hospital, Seoul
RECRUITING
Samsung Medical Center, Seoul
RECRUITING
Hospital General Universitario de Elche, Elche
RECRUITING
ICO L'Hospitalet, L'Hospitalet de Llobregat
RECRUITING
Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Barcelona
RECRUITING
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital, Ankara
RECRUITING
Ankara City Hospital, Ankara
RECRUITING
Princess Alexandra Hospital, Harlow
RECRUITING
St Bartholomew's Hospital, London
RECRUITING
Royal Free Hospital, London
RECRUITING
Churchill Hospital - Oxford Cancer & Haematology Centre, Oxford
Hoffmann-La Roche
INDUSTRY