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Targeted drug combo shows promise for rare breast cancer subtype

NCT ID NCT04024436

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial tested the drug futibatinib (TAS-120), alone or with the hormone therapy fulvestrant, in people with metastatic breast cancer that has specific FGFR gene changes. The study aimed to see if the treatment could shrink tumors or slow cancer growth. However, the trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
Futibatinib (TAS-120) and fulvestrant
What this could lead to
If successful, this could point toward a new treatment option for people with metastatic breast cancer that has specific FGFR gene changes.
What could go wrong
This trial was terminated early, so results are limited. It is a small, early-phase study, and the drug may not work for everyone or may cause 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

64 people

The number who actually took part.

Started

Jan 2020

Finished

Sep 2023

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: 1. Provide written informed consent 2. Age ≥ 18 years of age 3. Histologically or cytologically confirmed recurrent locally advanced or metastatic breast cancer not amenable to treatment with curative intent, and the following cohort specific criteria: A. Cohort 1 * HR+ HER2- breast cancer harboring an FGFR2 gene amplification. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 * Has received 1-3 prior endocrine-containing therapies and up to 2 prior chemotherapy regimens for advanced/metastatic disease * Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment B. Cohort 2 * TNBC harboring an FGFR2 gene amplification * Measurable disease per RECIST 1.1 * Has received at least 1 prior chemotherapy or chemotherapy/immunotherapy (PD-L1/PD-1 inhibitors) regimen for advanced/metastatic disease C. Cohort 3 * TNBC or HR+ HER2- breast cancer harboring an FGFR2 gene amplification * Non measurable, evaluable disease per RECIST 1.1. Patients with bone-only disease must have lytic or mixed lytic-blastic lesions * Other criteria for either HR+ HER2- breast cancer or TNBC should be met as described for Cohort 1 and 2, respectively D. Cohort 4 * HR+ HER2- breast cancer harboring an FGFR1 high-level gene amplification * Measurable disease per RECIST 1.1 * Has received 1-2 prior endocrine-containing therapies and no more than 1 prior chemotherapy regimen for advanced/metastatic disease. Prior treatment with fulvestrant is not permitted. * Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment * Pre/peri-menopausal patients must be on goserelin 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Archival or (preferably) fresh tumor tissue must be available 6. Adequate organ function Exclusion Criteria: 1. History and/or current evidence of any of the following disorders: 1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant 2. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant 3. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant 2. Prior treatment with an FGFR inhibitor 3. A serious illness or medical condition(s) 4. Brain metastases that are untreated or clinically or radiologically unstable 5. Pregnant or lactating female

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

FGFR 1 high amplification FGFR2 amplification Metastatic breast cancer

Contacts and locations

Locations

  • AOU Modena Policlinico

    Modena, Italy

  • AOU Policlinico - Vittorio Emanuele

    Catania, 95123, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • BIDMC

    Boston, Massachusetts, 02115, United States

  • Centre Leon Berard

    Lyon, 69008, France

  • Centro Hospitalar Universitario Lisboa Norte

    Lisbon, 1649-035, Portugal

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308, United States

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • HCA Healthcare UK

    London, England, W1G 6AD, United Kingdom

  • HCA Midwest Health

    Kansas City, Missouri, 64132, United States

  • Institut Gustave Roussy

    Villejuif, Cedex, 94805, France

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200-072, Portugal

  • Istituto Europeo Di Oncologia - IEO

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • MD Anderson

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - AZ

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic - FL

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - MN

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Ospedale E. Agnelli

    Pinerolo, 10064, Italy

  • Porto University

    Porto, 4099-001, Portugal

  • START Madrid - CIOCC

    Madrid, 28050, Spain

  • SunnyBrook Health Sciences

    Toronto, M4N 3M5, Canada

  • Tennessee Oncology

    Chattanooga, Tennessee, 37404, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, England, SM2 5PT, United Kingdom

  • Tom Baker Cancer Center

    Calgary, T2N 4N2, Canada

  • USCF

    San Francisco, California, 94115, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University Gregorio Marañon

    Madrid, 28007, Spain

  • Vall d'Hebron

    Barcelona, 08035, Spain

More trials for these conditions

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