NCT04024436

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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

Conditions

• Metastatic Breast Cancer
• FGFR 1 High Amplification
• FGFR2 Amplification

Interventions

Type	Name	Description
DRUG	Futibatinib	Futibatinib 20mg once daily on a 28-day cycle
DRUG	Futibatinib plus Fulvestrant	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.

Timeline

• Start date: 2020-01-28
• Primary completion: 2023-05-31
• Completion: 2023-09-06
• First posted: 2019-07-18
• Last updated: 2025-11-13
• Results posted: 2025-11-13

Locations

37 sites across 7 countries: United States, Canada, France, Italy, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study