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Metastatic Breast CancerPhase 2NCT04024436

A Study of TAS-120 in Patients With Metastatic Breast Cancer

A Phase 2 study testing Futibatinib and Futibatinib plus Fulvestrant in people with Metastatic Breast Cancer and FGFR 1 High Amplification, run by Taiho Oncology, Inc. at 37 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Futibatinib and Futibatinib plus Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
37 sitesin 7 countries
Study dates
28 Jan 2020to 6 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent
  • Age ≥ 18 years of age
  • Histologically or cytologically confirmed recurrent locally advanced or metastatic breast cancer not amenable to treatment with curative intent, and the following cohort specific criteria:
  • Cohort 1
  • HR+ HER2- breast cancer harboring an FGFR2 gene amplification.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Show all 25Show fewer
  • 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
  • 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
  • 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
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Archival or (preferably) fresh tumor tissue must be available
  • Adequate organ function

Who cannot join

  • History and/or current evidence of any of the following disorders:
  • Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant
  • Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant
  • Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant
  • Prior treatment with an FGFR inhibitor
  • A serious illness or medical condition(s)
  • Brain metastases that are untreated or clinically or radiologically unstable
  • Pregnant or lactating female

Trial locations and contacts

37 sites in 7 countries.

37 sites in 7 countries

United States17 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • BIDMC

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • UT Southwestern

    Dallas, Texas, 75390

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • MD Anderson

    Houston, Texas, 77030

  • Mayo Clinic - FL

    Jacksonville, Florida, 32224

  • HCA Midwest Health

    Kansas City, Missouri, 64132

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Mayo Clinic - AZ

    Phoenix, Arizona, 85054

  • Mayo Clinic - MN

    Rochester, Minnesota, 55905

  • USCF

    San Francisco, California, 94115

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

Other trials in United States

Italy7 sites

  • AOU Policlinico - Vittorio Emanuele

    Catania, 95123

  • Istituto Europeo Di Oncologia - IEO

    Milan, 20141

  • AOU Modena Policlinico

    Modena

  • Ospedale E. Agnelli

    Pinerolo, 10064

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

Other trials in Italy

Portugal3 sites

  • Centro Hospitalar Universitario Lisboa Norte

    Lisbon, 1649-035

  • Porto University

    Porto, 4099-001

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200-072

Other trials in Portugal

Spain3 sites

  • Vall d'Hebron

    Barcelona, 08035

  • University Gregorio Marañon

    Madrid, 28007

  • START Madrid - CIOCC

    Madrid, 28050

Other trials in Spain

United Kingdom3 sites

  • HCA Healthcare UK

    London, England, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Canada2 sites

  • Tom Baker Cancer Center

    Calgary, T2N 4N2

  • SunnyBrook Health Sciences

    Toronto, M4N 3M5

Other trials in Canada

France2 sites

  • Centre Leon Berard

    Lyon, 69008

  • Institut Gustave Roussy

    Villejuif, Cedex, 94805

Other trials in France

About this study

Official title: A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

Read the detailed description

This is a Phase 2, open-label, non-randomized, multicenter study designed to evaluate the efficacy and safety of futibatinib (TAS-120) and futibatinib + fulvestrant in up to 168 adult patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications. Patients will be enrolled to 1 of 4 treatment cohorts based on diagnosis and FGFR gene amplification status, and will receive either single agent futibatinib in Cohorts 1-3 or futibatinib plus fulvestrant in Cohort 4, as follows:

  • Cohort 1 - HR+ HER2- Measurable Disease w/ FGFR2 Amplification
  • Cohort 2 - TNBC Measurable Disease w/ FGFR2 Amplification
  • Cohort 3 - HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification
  • Cohort 4 - HR+ HER2- Measurable Disease w/ FGFR1 Amplification
Being tested
Futibatinib, Futibatinib plus Fulvestrant
Keywords
Futibatinib, Metastatic Breast Cancer, FGFR, TAS-120
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FutibatinibDrug

    Also called TAS-120

    Futibatinib 20mg once daily on a 28-day cycle

  • Futibatinib plus FulvestrantDrug

    Futibatinib 20mg once daily on a 28-day cycle and fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle.

Study groups in NCT04024436
Study groupRoleWhat they receive
Futibatinib (Cohort 1)ExperimentalParticipants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.
Receives: Drug: Futibatinib
Futibatinib (Cohort 2)ExperimentalParticipants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.
Receives: Drug: Futibatinib
Futibatinib (Cohort 3)ExperimentalParticipants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.
Receives: Drug: Futibatinib
Futibatinib Plus Fulvestrant (Cohort 4)ExperimentalParticipants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Receives: Drug: Futibatinib plus Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) - Cohorts 1, 2

    ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  2. Clinical Benefit Rate (CBR) - Cohort 3

    CBR was defined as the percentage of participants with a confirmed response of CR or stable disease (SD) lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  3. 6-month Progression-free Survival (PFS) Rate - Cohort 4

    The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place.

    Measured: At the end of every 2 cycles until disease progression (up to 6 months)

Secondary outcomes (9)

  1. Complete Response (CR) Rate - Cohort 3

    CR rate was defined as the percentage of participants who achieved CR. CR was defined as disappearance of all targets. Any pathological lymph node must have reduction in short axis to <10 mm. Percentages were rounded off to the nearest single decimal place.

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  2. Overall Response Rate (ORR) - Cohort 4

    ORR was defined as the percentage of participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  3. Clinical Benefit Rate (CBR) - Cohort 1,2, and 4

    CBR was defined as the percentage of participants with a confirmed response of CR, PR or SD lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest single decimal place.

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  4. 6-month PFS Rate - Cohorts 1,2, and 3

    The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place.

    Measured: At the end of every 2 cycles until disease progression (up to 6 months)

  5. Progression Free Survival (PFS)

    PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression based on investigator assessment, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  6. Duration of Response (DOR)

    DOR was defined as the time from the first documentation of objective response to the to the date of death (any cause) or disease progression, based on Investigator assessment, whichever occurs first. Objective response was defined as participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.

    Measured: At the end of every 2 cycles until disease progression (up to 40 months)

  7. Overall Survival (OS)

    OS was defined as the time (in months) from the date of first dose of the study drug to the date of death. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure.

    Measured: Up to 40 months

  8. Number of Participants With Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug.

    Measured: From the first dose of study drug up to 30 days after the last dose (Up to 40 months)

  9. Number of Participants With Dose Limiting Toxicities (DLTs) - Cohort 4

    A DLT was defined as any AE that occurs during Cycle 1 that is not clearly attributable to an extraneous cause, such as an underlying disease, occurring in Cycle 1, and meeting at least one of the criteria defined in the protocol. An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug.

    Measured: Cycle 1 (cycle length= 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start28 Jan 2020
  3. Primary completion31 May 2023
  4. Study completion6 Sep 2023

Why it stopped: The Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04024436
Sponsor's protocol ID
FOENIX-MBC2 TAS-120-201
Other IDs
2019-001164-30, 2019
Status last verified
Oct 2025
First submitted
24 Jun 2019
Last updated
13 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Futibatinib and Futibatinib plus Fulvestrant in people with Metastatic Breast Cancer and FGFR 1 High Amplification, run by Taiho Oncology, Inc. at 37 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Italy, Portugal, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) - Cohorts 1, 2 (time frame: At the end of every 2 cycles until disease progression (up to 40 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.

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