RecruitingPhase 2NCT07054190

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

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

Sponsor

Hoffmann-La Roche

Enrollment

60 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests inavolisib — a targeted therapy that blocks a specific cell growth signal called PI3K — in women with early-stage breast cancer that is hormone receptor-positive (HR+) and HER2-negative, with a specific mutation in the PIK3CA gene. Researchers want to see if adding this drug before surgery can shrink tumors more effectively. **You may be eligible if...** - You are a woman with early-stage hormone receptor-positive, HER2-negative breast cancer - Your tumor has a PIK3CA mutation (a specific genetic change your doctor can test for) - You have not yet started treatment and are planned for surgery - You are in good general health and meet organ function requirements **You may NOT be eligible if...** - Your cancer is HER2-positive - Your cancer does not have a PIK3CA mutation - You have metastatic (spread) breast cancer - You have diabetes requiring insulin, or significant heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInavolisib

Inavolisib will be administered as per the schedule specified in the arms

DRUGRibociclib

Ribociclib will be administered as per the schedule specified in the arms

DRUGLetrozole

Letrozole will be administered as per the schedule specified in the arms

Locations(30)

Community Clinical Trials

Orange, California, United States

Hospital Aleman de Buenos Aires

Buenos Aires, Argentina

Centro Médico Fleischer

Buenos Aires, Argentina

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

View Full Details on ClinicalTrials.gov

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NCT07054190

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