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A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Sponsor: Hoffmann-La Roche
Summary
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Official title: A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-09
Completion Date
2027-09-28
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Inavolisib
Inavolisib will be administered as per the schedule specified in the arms
Ribociclib
Ribociclib will be administered as per the schedule specified in the arms
Letrozole
Letrozole will be administered as per the schedule specified in the arms
Locations (27)
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Das Brustzentrum
Berlin, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, Germany
Kliniken Essen-Mitte
Essen, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, Germany
HELIOS Klinikum Schwerin
Schwerin, Germany
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center.
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain