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A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07054190•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
•Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
•Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
•Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
•Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
•Documented Ki-67 score \>=5% as per local assessment
•Confirmed PIK3CA mutation

Exclusion Criteria

•Stage IV (metastatic) BC
•Inflammatory BC (cT4d)
•Bilateral invasive BC
•History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
•Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
•Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Locations (25)

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

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

Key Dates

Start Date

September 9, 2025

Primary Completion Date

July 31, 2027

Completion Date

September 28, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Inavolisib

DRUG

Ribociclib

DRUG

Letrozole

DRUG

Contacts

Reference Study ID Number: BO45853 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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