NCT07054190From ClinicalTrials.govRecruiting

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

Breast Cancer

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Hoffmann-La Roche
Enrolment target: 120
Started: 9 September 2025
Main results due: 31 July 2027
Study sites: 34
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(34)

Los Angeles Cancer Network
Los Angeles, California, United States
Recruiting
Community Clinical Trials
Orange, California, United States
Recruiting
West Cancer Center
Germantown, Tennessee, United States
Recruiting
West Virginia University
Morgantown, West Virginia, United States
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, Brazil
Recruiting
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia, Canada
Recruiting
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Recruiting
Jewish General Hospital
Montreal, Quebec, Canada
Recruiting
McGill University Health Center
Montreal, Quebec, Canada
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

Showing 34 of 34 sites. 34 of the 34 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07054190. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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