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.
Additional locations may be listed on ClinicalTrials.gov for NCT04024436.
See trial information on ClinicalTrials.gov for a list of participating sites.
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
Lead OrganizationTaiho Pharmaceutical Company Limited
