230
Participants
Start Date
September 8, 2023
Primary Completion Date
September 28, 2026
Study Completion Date
December 28, 2032
Inavolisib
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Placebo
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Taxane-based Chemotherapy
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Optional Endocrine Therapy of Investigator's Choice
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
RECRUITING
National Taiwan Uni Hospital, Taipei
RECRUITING
Chang Gung Memorial Hospital-Linkou, Taoyuan
RECRUITING
Institut Salah Azeiz, Tunis
RECRUITING
Institut Jules Bordet, Anderlecht
RECRUITING
Cliniques Universitaires St-Luc, Brussels
RECRUITING
Kinghorn Cancer Centre, Darlinghurst
ACTIVE_NOT_RECRUITING
Chris Hani Baragwanath Clinical Trial Site, Soweto
RECRUITING
Abderrahmen Mami Hospital, Aryanah
RECRUITING
Charlotte Maxeke Academic Hospital, Johannesburg
RECRUITING
Medical Oncology Centre of Rosebank, Johannesburg
RECRUITING
Gosford Hospital, Gosford
RECRUITING
Habib Bourguiba Hospital, Sfax
RECRUITING
Monash Health, Clayton
RECRUITING
Hopelands Cancer Centre, Hilton
RECRUITING
Jessa Zkh (Campus Virga Jesse), Hasselt
RECRUITING
Farhat Hached Hospital, Sousse
RECRUITING
University of the Sunshine Coast, Sippy Downs
RECRUITING
Clinique Ste-Elisabeth, Namur
RECRUITING
GHdC Site Les Viviers, Charleroi
RECRUITING
Sir Charles Gairdner Hospital, Perth
RECRUITING
Taher Maamouri Hospital, Nabeul
ACTIVE_NOT_RECRUITING
National Cancer Center, Goyang-si
RECRUITING
King Hussein Cancer Center, Amman
RECRUITING
HELIOS Klinikum Berlin-Buch, Berlin
RECRUITING
Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña
RECRUITING
Gynäkologie Kompetenzzentrum, Stralsund
RECRUITING
Georgetown Uni Hospital, Washington D.C.
RECRUITING
Ospedale San Raffaele, Milan
RECRUITING
Irccs Istituto Nazionale Dei Tumori (Int), Milan
RECRUITING
Irccs Istituto Europeo Di Oncologia (IEO), Milan
RECRUITING
Turku Uni Central Hospital, Turku
RECRUITING
Medstar Research Institute, Hyattsville
RECRUITING
Ospedale San Gerardo, Monza
RECRUITING
Centre Georges Francois Leclerc, Dijon
RECRUITING
Dicle University Faculty of Medicine, Diyarbakır
RECRUITING
Hospital General Universitario Gregorio Marañon, Madrid
RECRUITING
Hospital Ramon y Cajal, Madrid
ACTIVE_NOT_RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
A.O.U. Maggiore della Carità, Novara
RECRUITING
Atrium Health, Charlotte
RECRUITING
Hospital Clinico Universitario Virgen de la Victoria, Málaga
RECRUITING
Polyclinique Bordeaux Nord Aquitaine, Bordeaux
RECRUITING
Tampere University Hospital, Tampere
RECRUITING
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul
RECRUITING
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul
RECRUITING
Katip Celebi University Ataturk Training and Research Hospital, Izmir
RECRUITING
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento", Verona
RECRUITING
Gynonco Düsseldorf, MVZ Medical Center GmbH, Düsseldorf
RECRUITING
Hospital Universitario Virgen Macarena, Seville
RECRUITING
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara
RECRUITING
Marienhospital Bottrop gGmbH, Bottrop
RECRUITING
I.R.S.T Srl IRCCS, Meldola
RECRUITING
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren, Münster
RECRUITING
Henry Ford Hospital, Detroit
RECRUITING
Ospedale Santa Maria Annunziata, Bagno a Ripoli
RECRUITING
Sakarya Training and Research Hospital, Adapazarı
RECRUITING
Centre Oscar Lambret, Lille
RECRUITING
Centre Hospitalier de La Cote Basque, Bayonne
RECRUITING
Hospital Universitario, Monterrey
RECRUITING
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum, Saarbrücken
RECRUITING
Hightower Clinical, Oklahoma City
RECRUITING
JPS Health Network, Fort Worth
WITHDRAWN
Lumi Research, Kingwood
RECRUITING
Renovatio Clinical, The Woodlands
RECRUITING
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau
RECRUITING
Renovatio Clinical - El Paso, El Paso
RECRUITING
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt, München
RECRUITING
Institut Sainte Catherine, Avignon
RECRUITING
Banner Health MD Anderson AZ, Gilbert
RECRUITING
Universitätsfrauenklinik Ulm, Ulm
RECRUITING
Renown Regional Medical Center, Reno
RECRUITING
Ellison Institute of Technology, Los Angeles
RECRUITING
Casa di Cura La Maddalena, Palermo
RECRUITING
Universitätsklinikum Erlangen, Erlangen
RECRUITING
Disney Family Cancer Center, Burbank
RECRUITING
Klinikum St. Marien, Amberg
RECRUITING
Frauenarztpraxis Dr. Apel, Dr. Kolpin, Erfurt
RECRUITING
Beijing Cancer Hospital, Beijing
RECRUITING
Max Super Speciality Hospital, NEW Delhi Delhi
RECRUITING
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogota, D.C.
RECRUITING
National University Hospital, Singapore
RECRUITING
Artemis Hospital, Gurugram
RECRUITING
The First Hospital of Jilin University, Changchun
RECRUITING
Harbin Medical University Tumor Hospital, Harbin
ACTIVE_NOT_RECRUITING
National Cancer Centre, Singapore
RECRUITING
Sociedad de Oncología y hematología del Cesar Ltda, Valledupar
WITHDRAWN
Icon Cancer Centre Farrer Park, Singapore
RECRUITING
Oncomedica S.A., Montería
RECRUITING
Shandong Cancer Hospital, Jinan
RECRUITING
Tianjin Cancer Hospital, Tianjin
WITHDRAWN
Tan Tock Seng Hospital, Singapore
RECRUITING
Zhejiang Cancer Hospital, Hangzhou
RECRUITING
The Second Affiliated Hospital to Nanchang University, Nanchang
RECRUITING
Fujian Cancer Hospital, Fuzhou
RECRUITING
Gujarat Cancer & Research Inst., Ahmedabad
RECRUITING
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd), Surat
RECRUITING
Sir H. N. Reliance Foundation Hospital and Research Centre, Mumbai
RECRUITING
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
RECRUITING
Hubei Cancer Hospital, Wuhan
RECRUITING
National Cancer Institute, Nagpur
RECRUITING
The First Affiliated Hospital to Henan University of Science and Technology, Luoyang
RECRUITING
Shantou Center Hospital, Shantou
RECRUITING
Guangxi Cancer Hospital of Guangxi Medical University, Nanning
RECRUITING
Sichuan Provincial Cancer Hospital, Chengdu
RECRUITING
Sichuan Provincial People's Hospital, Chengdu
RECRUITING
Tata Medical Center, Kolkata
RECRUITING
Dana Farber Cancer Institute, Boston
RECRUITING
Hackensack University Medical Center, Hackensack
RECRUITING
Kadlec Clinic Hematology and Oncology, Kennewick
RECRUITING
Swedish Medical Center, Seattle
ACTIVE_NOT_RECRUITING
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires
RECRUITING
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires
RECRUITING
Instituto de Oncología de Rosario, Rosario
RECRUITING
Hospital Provincial del Centenario, Rosario
RECRUITING
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan
WITHDRAWN
Clínica Viedma, Viedma Rio Negro
RECRUITING
Blacktown Hospital, Blacktown
RECRUITING
Crio - Centro Regional Integrado de Oncologia, Fortaleza
RECRUITING
Hospital Sao Rafael - HSR, Salvador
RECRUITING
Hospital Araujo Jorge, Goiânia
RECRUITING
Hospital do Câncer de Londrina, Londrina
RECRUITING
Hospital do Cancer de Pernambuco - HCP, Recife
ACTIVE_NOT_RECRUITING
Santa Casa de Misericordia de Porto Alegre, Porto Alegre
RECRUITING
Hospital Sao Lucas - PUCRS, Porto Alegre
RECRUITING
Hospital de Amor Amazônia, Porto Velho
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
Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary
RECRUITING
The Moncton Hospital, Moncton
RECRUITING
Eastern Health - General Hospital, St. John's
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
Centre Hospitalier de l?Université de Montréal (CHUM), Montreal
RECRUITING
Jewish General Hospital, Montreal
RECRUITING
Hôpital du Sacré-Coeur de Montreal, Montreal
RECRUITING
Hopital du Saint Sacrement, Québec
RECRUITING
Allan Blair Cancer Center, Regina
RECRUITING
Affiliated Hospital of Hebei University, Baoding
WITHDRAWN
Clinica De La Costa, Barranquilla
RECRUITING
Queen Mary Hospital, Hong Kong
RECRUITING
Tuen Mun Hospital, Hong Kong
RECRUITING
University of Nairobi - Institute of Tropical and Infectious Diseases, Nairobi
RECRUITING
Sultan Qaboos Comprehensive Cancer Care & Research Center, Muscat
RECRUITING
Tri-Service General Hospital, Taipei
RECRUITING
Ospedale San Giovanni Addolorata, Rome
RECRUITING
OncoMed, Mexico City
RECRUITING
CENEIT Oncologicos, Mexico City
RECRUITING
Centro Oncológico Hematológico Roma, Mexico City
RECRUITING
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka, Bydgoszcz
RECRUITING
Uniwersyteckie Centrum Kliniczne, Gda?sk
RECRUITING
Szpital Morski im.PCK, Gdynia
RECRUITING
Narodowy Instytut Onkologii Odzia? w Gliwicach, Gliwice
RECRUITING
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin
RECRUITING
Szpital Wojewódzki im. Miko?aja Kopernika, Koszalin
RECRUITING
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie, Późna
RECRUITING
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie, Warsaw
RECRUITING
Limpopo Cancer Research Institute, Polokwane
RECRUITING
Steve Biko Academic Hospital, Pretoria
RECRUITING
Seoul National University Hospital, Seoul
ACTIVE_NOT_RECRUITING
Severance Hospital, Yonsei University Health System, Seoul
COMPLETED
Asan Medical Center, Seoul
ACTIVE_NOT_RECRUITING
Gangnam Severance Hospital, Seoul
ACTIVE_NOT_RECRUITING
Samsung Medical Center, Seoul
ACTIVE_NOT_RECRUITING
Seoul St Mary's Hospital, Seoul
RECRUITING
Hospital Universitari Dexeus - Grupo Quironsalud, Barcelona
RECRUITING
Hospital Universitari Vall d'Hebron, Barcelona
RECRUITING
Gulhane Training and Research Hospital, Ankara
RECRUITING
Gazi University Medical Faculty, Ankara
ACTIVE_NOT_RECRUITING
Medical Park Seyhan Hospital, Seyhan
RECRUITING
Hacettepe Uni Medical Faculty Hospital, Sihhiye/Ankara
RECRUITING
Uganda Cancer Institute, Kampala
RECRUITING
Belfast City Hospital, Belfast
RECRUITING
Blackpool Victoria Hospital, Blackpool
RECRUITING
Colchester General Hospital, Colchester, Essex
RECRUITING
Mount Vernon Hospital, Northwood
RECRUITING
Nottingham City Hospital, Nottingham
RECRUITING
Churchill Hospital, Oxford
Hoffmann-La Roche
INDUSTRY