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Targeted combo aims to shrink breast tumors before surgery

NCT ID NCT07054190

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests whether combining the drug inavolisib with other treatments can safely shrink or eliminate early-stage breast tumors that have a specific genetic change (PIK3CA mutation). About 60 people with untreated stage II-III breast cancer will receive the drug combination before surgery. The main goals are to check safety and see how many patients have no cancer left at surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center.

    RECRUITING

    Seoul, 05505, South Korea

  • BC Cancer - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    RECRUITING

    Montreal, Quebec, H2X 0C2, Canada

  • Centro Médico Fleischer

    RECRUITING

    Buenos Aires, C1414DRK, Argentina

  • Centro Oncologico Korben

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

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

    RECRUITING

    São Paulo, São Paulo, 01317-000, Brazil

  • Community Clinical Trials

    RECRUITING

    Orange, California, 92868, United States

  • Das Brustzentrum

    RECRUITING

    Berlin, 12623, Germany

  • HELIOS Klinikum Berlin-Buch

    RECRUITING

    Berlin, 13125, Germany

  • HELIOS Klinikum Schwerin

    RECRUITING

    Schwerin, 19055, Germany

  • Hospital Aleman de Buenos Aires

    RECRUITING

    Buenos Aires, C1118AAT, Argentina

  • Hospital Araujo Jorge

    RECRUITING

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital do Cancer de Pernambuco - HCP

    RECRUITING

    Recife, Pernambuco, 50040-000, Brazil

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T1E2, Canada

  • Kliniken Essen-Mitte

    RECRUITING

    Essen, 45136, Germany

  • Los Angeles Cancer Network

    RECRUITING

    Los Angeles, California, 90017-4803, United States

  • McGill University Health Center

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

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

    RECRUITING

    Paderborn, 33098, Germany

  • Sunnybrook Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

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

    RECRUITING

    Barcelona, 08035, Spain

  • West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.