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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
Sponsor: Hoffmann-La Roche
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).
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-04-07
Completion Date
2030-02-26
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
Inavolisib
Inavolisib will be administered as per the schedule mentioned in the protocol.
Ribociclib
Ribociclib will be administered as per the schedule mentioned in the protocol.
Fulvestrant
Fulvestrant will be administered as per the schedule mentioned in the protocol.
Placebo
Placebo will be administered as per the schedule mentioned in the protocol.
Locations (36)
Avera Cancer Institute - Marshall
Marshall, Minnesota, United States
Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota, United States
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, United States
Avera Cancer Institute - Pierre, SD
Pierre, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
AMG Oncology and Hematology Avera Cancer Institute - Yankton
Yankton, South Dakota, United States
Centro Oncologico Korben
Caba, Argentina
Centro Médico Fleischer
Capital Federal, Argentina
Sanatorio de la Mujer
Rosario, Argentina
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo, Brazil
Hospital Brasilia
Brasília, Federal District, Brazil
ICTR Curitiba
Curitiba, Paraná, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Chicoutimi, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Centre Leon Berard
Lyon, France
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
Università Campus Bio-Medico di Roma
Rome, Lazio, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Bialostockie Centrum Onkologii
Bialystok, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, Poland
Dolno?l?skie Centrum Onkologii
Wroc?aw, Poland
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, South Korea
Gachon University Gil Medical Center
Namdong-Gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Clinic I Provincial
Barcelona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Leicester Royal Infirmary
Leicester, United Kingdom
Christie Hospital Nhs Trust
Manchester, United Kingdom