A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Start Date
4/7/2026
Completion Date
2/26/2030
Summary
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Inavolisib
Ribociclib
Fulvestrant
Placebo
Conditions
Locations
Avera Cancer Institute - Marshall
Marshall, Minnesota 56258
United States
Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota 57401
United States
Avera Cancer Institute - Mitchell
Mitchell, South Dakota 57301
United States
Avera Cancer Institute - Pierre, SD
Pierre, South Dakota 57501
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
AMG Oncology and Hematology Avera Cancer Institute - Yankton
Yankton, South Dakota 57078
United States
Inst. Alexander Fleming
Buenos Aires, C1426ANZ
Argentina
Centro Oncologico Korben
Caba, C1426AGE
Argentina
Centro Médico Fleischer
Capital Federal, C1414
Argentina
Sanatorio de la Mujer
Rosario, S2000ORE
Argentina
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo 29043-260
Brazil
Hospital Brasilia
Brasília, Federal District 71.635-610
Brazil
ICTR Curitiba
Curitiba, Paraná 80510-130
Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo 01317-000
Brazil
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Chicoutimi, Quebec G7H 5H6
Canada
McGill University
Montreal, Quebec H4A 3J1
Canada
Centre Oscar Lambret
Lille, 59020
France
Centre Leon Berard
Lyon, 69008
France
Institut Paoli Calmettes
Marseille, 13273
France
Institut Régional du Cancer de Montpellier
Montpellier, 34298
France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Toulouse, 31059
France
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin
Aachen, 52074
Germany
Universitätsklinik Tübingen
Tübingen, 72076
Germany
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania 80131
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna 47014
Italy
Università Campus Bio-Medico di Roma
Rome, Lazio 128
Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy 24127
Italy
Ospedale San Raffaele
Milan, Lombardy 20132
Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy 20133
Italy
Instituto Nacional De Cancerologia
Distrito Federal, Mexico CITY (federal District) 14000
Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca 68020
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
Mexico
Instytut "Centrum Zdrowia Matki Polki"
?ód?, 93-338
Poland
Bialostockie Centrum Onkologii
Bialystok, 15-027
Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090
Poland
Dolno?l?skie Centrum Onkologii
Wroc?aw, 53-413
Poland
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, 31151
South Korea
Gachon University Gil Medical Center
Namdong-Gu, 21565
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital Clinic Barcelona
Barcelona, 08036
Spain
Hospital Universitario Clínico San Cecilio
Granada, 18016
Spain
Hospital Ramon y Cajal
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Leicester Royal Infirmary
Leicester, LE1 5WWi
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
Christie Hospital Nhs Trust
Manchester, M20 4GJ
United Kingdom