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New drug cocktail targets Hard-to-Treat breast cancer

NCT ID NCT07405801

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 6 times

Summary

This phase 2 trial is testing whether adding a drug called inavolisib to two standard treatments (ribociclib and fulvestrant) can shrink tumors or slow cancer growth in people with advanced hormone-receptor-positive, HER2-negative breast cancer that has a specific genetic change (loss of chromosome 8p) but no PIK3CA mutation. About 80 participants will be randomly assigned to receive either the three-drug combo or a placebo plus the two standard drugs. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inavolisib, ribociclib, and fulvestrant
What this could lead to
If successful, this could offer a new targeted treatment option for people with a specific type of advanced breast cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early phase 2 trial with only 80 participants, so results may not apply to everyone. The combination may cause side effects or fail to improve outcomes compared to standard care.

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 80 people

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

Started

Apr 2026

Expected to finish

Feb 2030

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

Anyone

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: * Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020) * Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen * Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss) * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Exclusion Criteria: * Metaplastic breast cancer * Radiotherapy within 2 weeks before randomization * Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis) * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible * Any history of leptomeningeal disease or carcinomatous meningitis

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm 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

    58 sites in 12 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

  • AMG Oncology and Hematology Avera Cancer Institute - Yankton

    RECRUITING

    Yankton, South Dakota, 57078, United States

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    RECRUITING

    Guadalajara, 44280, Mexico

  • Asst Papa Giovanni XXIII

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Avera Cancer Institute - Aberdeen

    RECRUITING

    Aberdeen, South Dakota, 57401, United States

  • Avera Cancer Institute - Marshall

    RECRUITING

    Marshall, Minnesota, 56258, United States

  • Avera Cancer Institute - Mitchell

    RECRUITING

    Mitchell, South Dakota, 57301, United States

  • Avera Cancer Institute - Pierre, SD

    RECRUITING

    Pierre, South Dakota, 57501, United States

  • Bialostockie Centrum Onkologii

    RECRUITING

    Bialystok, 15-027, Poland

  • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

    RECRUITING

    Chicoutimi, Quebec, G7H 5H6, Canada

  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

    RECRUITING

    Lublin, 20-090, Poland

  • Cancer Specialists of North Florida

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • Centro Médico Fleischer

    RECRUITING

    Capital Federal, C1414, Argentina

  • Centro Oncologico Korben

    RECRUITING

    Caba, C1426AGE, Argentina

  • Centro de Investigacion Clinica de Oaxaca

    RECRUITING

    Oaxaca City, Oaxaca, 68020, Mexico

  • Christie Hospital Nhs Trust

    RECRUITING

    Manchester, M20 4GJ, United Kingdom

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

    RECRUITING

    São Paulo, São Paulo, 01317-000, Brazil

  • Dolno?l?skie Centrum Onkologii

    RECRUITING

    Wroc?aw, 53-413, Poland

  • Gachon University Gil Medical Center

    RECRUITING

    Namdong-Gu, 21565, South Korea

  • Hospital Brasilia

    RECRUITING

    Brasília, Federal District, 71.635-610, Brazil

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Santa Rita de Cassia Vitoria

    RECRUITING

    Vitória, Espírito Santo, 29043-260, Brazil

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • ICO L'Hospitalet

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • Ictrials Pesquisa e Desenvolvimento

    RECRUITING

    Curitiba, Paraná, 80510-130, Brazil

  • Inst. Alexander Fleming

    RECRUITING

    Buenos Aires, C1426ANZ, Argentina

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13273, France

  • Institut Régional du Cancer de Montpellier

    RECRUITING

    Montpellier, 34298, France

  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

    RECRUITING

    Toulouse, 31059, France

  • Instituto Nacional De Cancerologia

    RECRUITING

    Distrito Federal, Mexico CITY (federal District), 14000, Mexico

  • Instytut "Centrum Zdrowia Matki Polki"

    RECRUITING

    ?ód?, 93-338, Poland

  • Irccs Istituto Nazionale Dei Tumori (Int)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

    RECRUITING

    Naples, Campania, 80131, Italy

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WWi, United Kingdom

  • Los Angeles Cancer Network - Anaheim

    RECRUITING

    Anaheim, California, 92805, United States

  • McGill University

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nationales Centrum für Tumorerkrankungen (NCT)

    RECRUITING

    Heidelberg, 69120, Germany

  • Ospedale San Raffaele

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Ottawa General Hospital

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Sanatorio de la Mujer

    RECRUITING

    Rosario, S2000ORE, Argentina

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13605, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Soon Chun Hyang University Cheonan Hospital

    RECRUITING

    Dongnam-gu, Cheonan-si, 31151, South Korea

  • Stanford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304, United States

  • Städtisches Klinikum Dessau

    RECRUITING

    Dessau, 06847, Germany

  • Sunnybrook Health Science Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin

    RECRUITING

    Aachen, 52074, Germany

  • Università Campus Bio-Medico di Roma

    RECRUITING

    Rome, Lazio, 128, Italy

  • Universitätsklinik Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, 45122, Germany

More trials for these conditions

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