Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Mitogens

Futibatinib

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Group/Cohort 1 Description HR+ HER2- Measurable Disease w/ FGFR2 Amplification

Group/Cohort 2 Description TNBC Measurable Disease w/ FGFR2 Amplification

Group/Cohort 3 Description HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification

Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification

Futibatinib 20mg once daily on a 28 day cycle

Futibatinib 20mg once daily and 500 mg fulvestrant 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.

Futibatinib plus Fulvestrant

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

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

Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors

CBR is defined as the proportion of patients with a confirmed response of CR or SD lasting at least 24 weeks

The 6-month PFS rate is defined as the proportion of patients who are alive and progression-free 6 months after the first dose of study therapy

CR is defined as the disappearance of all target and/or non-target lesions

CBR is defined as the proportion of patient with a confirmed response of CR, PR or SD lasting at least 24 weeks

6-month PFS rate is defined as the proportion of patients who are alive and progression-free 6 months after the first dose of study therapy

PFS is defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression

DOR is defined as the time from first documentation of objective response to the date of death (any cause) or disease progression

OS is defined as the time (in months) from the first dose of study therapy to the date of death (any cause)

Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed

Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed using Common Terminology Criteria for Adverse Events (CTCAE - Version 5).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of TAS-120 in Patients With Metastatic Breast Cancer	NCT04024436	Metastatic Brea... FGFR 1 High Amp... FGFR2 Amplifica...	Futibatinib Futibatinib plu...	18 Years -	Taiho Oncology, Inc.
A Study of TAS-120 in Patients With Metastatic Breast Cancer	NCT04024436	Metastatic Brea... FGFR 1 High Amp... FGFR2 Amplifica...	Futibatinib Futibatinib plu...	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for futibatinib plus fulvestrant