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

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    Taiho Oncology, Inc.
Updated on 20 October 2022
platelet count
measurable disease
breast cancer
endocrine therapy
neutrophil count
hormone therapy
liver metastasis
cancer chemotherapy
progesterone receptor
estrogen receptor
her2-negative breast cancer


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.


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

Condition Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification
Treatment fulvestrant, TAS-120, Futibatinib, Futibatinib plus Fulvestrant
Clinical Study IdentifierNCT04024436
SponsorTaiho Oncology, Inc.
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

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
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 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
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

Exclusion Criteria

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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