South Texas Accelerated Research Therapeutics | START Madrid - CIOCC
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full 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:
Enrollment
Sex
Ages
Volunteers
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:
A. Cohort 1
B. Cohort 2
C. Cohort 3
D. Cohort 4
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:
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
Primary purpose
Allocation
Interventional model
Masking
168 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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