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New combo aims to shrink hard-to-treat breast tumors

NCT ID NCT07368998

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 5 times

Summary

This study tests two different doses of inavolisib combined with fulvestrant in people with a specific type of advanced breast cancer (PIK3CA-mutated, HR-positive, HER2-negative). About 80 participants whose cancer worsened after prior treatment will receive the drug combo. The goal is to see if a lower dose works as well with fewer side effects.

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

Feb 2026

Expected to finish

Oct 2031

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: * Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation * Life expectancy of \> 6 months * Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes Exclusion Criteria: * Metaplastic breast cancer * Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis

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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

    34 sites in 8 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

  • Adana Baskent University Hospital

    RECRUITING

    Adana, 01120, Turkey (Türkiye)

  • Astera Cancer Care East Brunswick

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Bagcilar Medipol Mega Universitesi Hastanesi

    RECRUITING

    Bağcılar, Istanbul, 34214, Turkey (Türkiye)

  • Bendigo Cancer Centre

    RECRUITING

    Bendigo, Victoria, 3550, Australia

  • Blackpool Victoria Hospital

    RECRUITING

    Blackpool, FY3 8NR, United Kingdom

  • Blacktown Hospital

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • CENEIT Oncologicos

    RECRUITING

    Mexico City, 03100, Mexico

  • Cancer Specialists of North Florida

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Centro Oncologico Korben

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

  • Centro Oncologico Riojano Integral (CORI)

    RECRUITING

    La Rioja, F5300COE, Argentina

  • Centro Oncológico de Excelencia

    RECRUITING

    San Juan, J5402BGA, Argentina

  • Centro de Infusion Tratamiento e Investigacion Oncologica S DE R

    RECRUITING

    Queretaro Qro, Querétaro, 76090, Mexico

  • Churchill Hospital - Oxford Cancer & Haematology Centre

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Clinique Ste-Elisabeth

    RECRUITING

    Namur, 5000, Belgium

  • Cliniques Universitaires St-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Coffs Harbour Health Campus

    RECRUITING

    Coffs Harbour, New South Wales, 2450, Australia

  • HCA Midwest Division

    RECRUITING

    Kansas City, Missouri, 64132, United States

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    RECRUITING

    Guadalajara, Jalisco, 44280, Mexico

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Privado - Centro Medico de Córdoba

    RECRUITING

    Córdoba, 5016, Argentina

  • Hospital Provincial del Centenario

    RECRUITING

    Rosario, S2002KDS, Argentina

  • Hospital Universitari Vall d'Hebron;Oncology

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 De Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • Instituto de Oncologia de Rosario

    RECRUITING

    Rosario, Santa Fe Province, S2000KPG, Argentina

  • Jessa Zkh (Campus Virga Jesse)

    RECRUITING

    Hasselt, 3500, Belgium

  • Los Angeles Cancer Network

    RECRUITING

    Los Angeles, California, 90017-4803, United States

  • Medical Park Seyhan Hospital

    RECRUITING

    Seyhan, Turkey (Türkiye)

  • Memorial Ankara Hastanesi

    RECRUITING

    Ankara, 06520, Turkey (Türkiye)

  • Mount Vernon Cancer Centre

    RECRUITING

    Northwood, Middlesex, HA6 2RN, United Kingdom

  • Princess Alexandra Hospital

    RECRUITING

    Harlow, CM20 1QX, United Kingdom

  • RENATI INNOVATION S.A.P.I. de C.V

    RECRUITING

    Guadalajara, Jalisco, 44680, Mexico

  • Sir Charles Gairdner Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

More trials for these conditions

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