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Clinical Trials in the USA / NCT07054190
Recruiting Phase 2

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

NCT07054190 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2025-09-09
Last updated
2026-08-31

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Inavolisib →Ribociclib →Letrozole →Giredestrant →

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

Giredestrant: Giredestrant will be administered as per the schedule specified in the arms

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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, and 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

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Los Angeles Cancer Network Los Angeles California Recruiting
Community Clinical Trials Orange California Recruiting
West Cancer Center Germantown Tennessee Recruiting
West Virginia University Morgantown West Virginia Recruiting
Hospital Aleman de Buenos Aires Buenos Aires Argentina Recruiting
Centro Médico Fleischer Buenos Aires Argentina Recruiting
Centro Oncologico Korben Ciudad Autonoma Buenos Aires Argentina Recruiting
Hospital Araujo Jorge Goiânia Goiás Recruiting
Hospital do Cancer de Pernambuco - HCP Recife Pernambuco Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda São Paulo São Paulo Recruiting
BC Cancer - Vancouver Vancouver British Columbia Recruiting
Sunnybrook Odette Cancer Centre Toronto Ontario Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) Montreal Quebec Recruiting
Jewish General Hospital Montreal Quebec Recruiting
McGill University Health Center Montreal Quebec Recruiting
Das Brustzentrum Berlin Germany Recruiting
HELIOS Klinikum Berlin-Buch Berlin Germany Recruiting
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden Dresden Germany Recruiting
Kliniken Essen-Mitte Essen Germany Recruiting
Universitätsklinikum Heidelberg Heidelberg Germany Recruiting
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise Paderborn Germany Recruiting
HELIOS Klinikum Schwerin Schwerin Germany Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting
Asan Medical Center. Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona Barcelona Spain Recruiting
Hospital Clinic Barcelona Barcelona Spain Recruiting
Hospital General Universitario Gregorio Marañon Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Clinico Universitario de Salamanca Salamanca Spain Recruiting
Hospital Universitario Virgen Macarena Seville Spain Recruiting
Hospital Clínico Universitario de Valencia Valencia Spain Recruiting

On this site

📄 Kisqali (ribociclib) drug profile →

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07054190 on ClinicalTrials.gov ↗ ← All trials in the USA