400
Participants
Start Date
June 7, 2023
Primary Completion Date
June 30, 2026
Study Completion Date
March 30, 2029
Inavolisib
Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle.
Fulvestrant
Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle.
Alpelisib
Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.
Chang Gung Memorial Hosipital at Linkou, Taoyuan
China Medical University Hospital, Taichung
Cliniques Universitaires St-Luc, Brussels
Kinghorn Cancer Centre, Darlinghurst
Concord Repatriation General Hospital, Concord
Medical Oncology Centre of Rosebank, Johannesburg
Gosford Hospital, Gosford
Coffs Harbour Health Campus, Coffs Harbour
UZ Antwerpen, Edegem
UZ Leuven Gasthuisberg, Leuven
Bendigo Cancer Centre, Bendigo
Richards Bay Oncology Centre, KwaZulu Natal
Clinique Ste-Elisabeth, Namur
GHdC Site Les Viviers, Charleroi
Sir Charles Gairdner Hospital, Perth
Mountain View Oncology, Paarl
UZ Gent, Ghent
Hospital San Pedro De Alcantara, Cáceres
National Taiwan University Hospital, Zhongzheng Dist.
National Cancer Center, Goyang-si
Taipei Veterans General Hospital, Taipei
Ospedale San Raffaele, Milan
Mammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg
Dicle University Faculty of Medicine, Diyarbakır
Trakya University Medical Faculty, Edirne
Inha University Hospital, Incheon
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Ramon y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Regional Universitario Carlos Haya, Málaga
Grady Health System, Atlanta
Midtown West Medical, Atlanta
Emory University Hospital, Atlanta
Winship Cancer Institute at Emory Saint Joseph's Hospital, Atlanta
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie, Hanover
IUCT Oncopole, Toulouse
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise, Paderborn
Polyclinique Bordeaux Nord, Bordeaux
Cleveland Clinic Florida, Weston
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul
ICM, Montpellier
Goztepe Prof.Dr. Suleyman Yalcin City Hospital, Kadiköy
Marmara Uni Faculty of Medicine, Istanbul
Centre Eugene Marquis, Rennes
Ege Uni Medical Faculty Hospital, Izmir
Katip Celebi University Ataturk Training and Research Hospital, Izmir
Universitätsmedizin Göttingen Georg-August-Universität, Göttingen
Ospedale Santa Chiara, Trento
Hospital Universitario de Canarias, San Cristóbal de La Laguna
Veterans General Hospital - Taichung, Xitun Dist.
Hospital Universitario Virgen Macarena, Seville
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH, Mönchengladbach
Kyungpook National University Chilgok Hospital, Daegu
Panamerican Clinical Research S.A de C.V., Guadalajara
RENATI INNOVATION S.A.P.I. de C.V, Guadalajara
Gabrail Cancer Center, Canton
Universitätsklinikum Essen, Essen
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola
Cancer & Hematology Centers of Western Michigan, Grand Rapids
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin, Aachen
Minnesota Oncology Hematology, Saint Paul
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Morelia
Centre Hospitalier de La Cote Basque, Bayonne
Centre Leon Berard, Lyon
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg
National Cheng Kung University Hospital, Tainan City
Texas Oncology - Dallas Presbyterian Hospital, Dallas
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau
Rocky Mountain Cancer Centers, Denver
A.O. S. Anna e San Sebastiano, Caserta
Institut Sainte Catherine, Avignon
Cancer Blood and Specialty Clinic, Los Alamitos
Humanitas Centro Catanese Di Oncologia, Misterbianco (CT)
UC Davis Comprehensive Cancer Center, Sacramento
The First Hospital of Jilin University, Changchun
Harbin Medical University Tumor Hospital, Harbin
Jiangsu Cancer Hospital, Nanjing
Tianjin Cancer Hospital, Tianjin
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou
Zhejiang Cancer Hospital, Zhejiang
The Second Affiliated Hospital to Nanchang University, Nanchang
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
Hubei Cancer Hospital, Wuhan
Sun yat-sen University Cancer Center, Guangzhou
Guangdong Provincial People's Hospital, Guangzhou
Sichuan Provincial Cancer Hospital, Chengdu
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an
Liga Norte Riograndense Contra O Câncer, Natal
Los Angeles Cancer Network, Los Angeles
Massachusetts General Hospital, Boston
Asante Rogue Regional Medical Center, Medford
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires
Fundacion CORI para la Investigacion y Prevencion del Cancer, La Rioja
Instituto de Oncología de Rosario, Rosario
Sanatorio Parque S.A., Rosario
Hosp Provincial D. Centenarios, Rosario
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan
Clinica Viedma S.A., Viedma
Hospital da Bahia, Salvador
NUPEC, Belo Horizonte
Hospital Santa Cruz / Centro de Oncologia D'Or, Curitiba
Hospital do Cancer de Pernambuco - HCP, Recife
Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife, 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
Hospital Sírio-Libanês, São Paulo
Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary
Cross Cancer Institute, Edmonton
BC Cancer ? Vancouver, Vancouver
The Moncton Hospital, Moncton
Juravinski Hospital, Hamilton
The Ottawa Hospital - General Campus, Ottawa
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont, Montreal
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal
Jewish General Hospital, Montreal
Hôpital du Sacré-Coeur de Montreal, Montreal
COI Centro Oncologico Internacional Santa Fe, Mexico City
Health Pharma Professional Research, Mexico City
OncoMed, Mexico City
CENEIT Oncologicos, Mexico City
ARKE Estudios Clínicos S.A. de C.V., Mexico City
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka, Bydgoszcz
Narodowy Instytut Onkologii Odzia? w Gliwicach, Gliwice
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin
Szpital Wojewódzki im. Miko?aja Kopernika, Koszalin
Szpital Uniwersytecki w Krakowie, Krakow
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie, Warsaw
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
Seoul St Mary's Hospital, Seoul
ICO L'Hospitalet, L'Hospitalet de Llobregat
Gulhane Training and Applicaton Hospital, Ankara
Memorial Ankara Hastanesi, Ankara
Medical Park Seyhan Hospital, Seyhan
Hacettepe Uni Medical Faculty Hospital, Sihhiye/Ankara
Basingstoke and North Hampshire Hospital, Basingstoke
Blackpool Victoria Hospital, Blackpool
Western General Hospital, Edinburgh
Princess Alexandra Hospital, Harlow
St Bartholomew's Hospital, London
Maidstone & Tonbridge Wells Hospital, Maidstone
Mount Vernon & Watford Trust Hospital, Northwood
Churchill Hospital, Oxford
Royal Hampshire County Hospital, Winchester
Hoffmann-La Roche
INDUSTRY