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NCT07054190PHASE2Recruiting

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

Hoffmann-La Roche

Start Date

9/9/2025

Completion Date

9/28/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Inavolisib

DRUG

Ribociclib

DRUG

Letrozole

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Conditions

Breast Cancer

Locations

Los Angeles Cancer Network

Los Angeles, California 90017-4803

United States

Community Clinical Trials

Orange, California 92868

United States

West Cancer Center

Germantown, Tennessee 38138

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Hospital Aleman de Buenos Aires

Buenos Aires, C1118AAT

Argentina

Centro Médico Fleischer

Buenos Aires, C1414DRK

Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE

Argentina

Hospital Araujo Jorge

Goiânia, Goiás 74605-070

Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco 50040-000

Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-074

Brazil

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo 01317-000

Brazil

Sunnybrook Odette Cancer Centre

Toronto, Ontario M4N 3M5

Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec H2X 0C2

Canada

Jewish General Hospital

Montreal, Quebec H3T1E2

Canada

McGill University Health Center

Montreal, Quebec H4A 3J1

Canada

Das Brustzentrum

Berlin, 12623

Germany

HELIOS Klinikum Berlin-Buch

Berlin, 13125

Germany

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307

Germany

Kliniken Essen-Mitte

Essen, 45136

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise

Paderborn, 33098

Germany

HELIOS Klinikum Schwerin

Schwerin, 19055

Germany

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center.

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035

Spain

Hospital Clinic Barcelona

Barcelona, 08036

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Clinico Universitario de Salamanca

Salamanca, 37007

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Clínico Universitario de Valencia

Valencia, 46010

Spain