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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer; FGFR2 Amplification; FGFR 1 High Amplification
• Intervention / Treatment: Drug: Futibatinib; Drug: Futibatinib plus Fulvestrant

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

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada, T2N 4N2
    • Tom Baker Cancer Center
  • Toronto, Canada, M4N 3M5
    • Sunnybrook Health Sciences
• France
  • Lyon, France, 69008
    • Centre Leon Berard
  • Cedex
    • Villejuif, Cedex, France, 94805
      • Institut Gustave Roussy
• Italy
  • Catania, Italy, 95123
    • AOU Policlinico - Vittorio Emanuele
  • Milan, Italy, 20141
    • Istituto Europeo Di Oncologia - IEO
  • Modena, Italy
    • AOU Modena Policlinico
  • Pinerolo, Italy, 10064
    • Ospedale E. Agnelli
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Portugal
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Universitario Lisboa Norte
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto
  • Porto, Portugal, 4099-001
    • Porto University
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron
  • Madrid, Spain, 28007
    • University Gregorio Marañon
  • Madrid, Spain, 28050
    • START Madrid - CIOCC
• United Kingdom
  • England
    • London, England, United Kingdom, W1G 6AD
      • HCA Healthcare UK
    • Manchester, England, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust
    • Sutton, England, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic - AZ
  • California
    • San Francisco, California, United States, 94115
      • USCF
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - FL
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • BIDMC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - MN
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Health
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • MD Anderson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide written informed consent
2. Age ≥ 18 years of age

3. 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

   • 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

   B. 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

   D. 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
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Archival or (preferably) fresh tumor tissue must be available
6. Adequate organ function

Exclusion Criteria:

1. History and/or current evidence of any of the following disorders:

   1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant
   2. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant
   3. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant
2. Prior treatment with an FGFR inhibitor
3. A serious illness or medical condition(s)
4. Brain metastases that are untreated or clinically or radiologically unstable
5. Pregnant or lactating female

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Futibatinib (Cohort 1); Participants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.	Drug: Futibatinib; Futibatinib 20mg once daily on a 28-day cycle; Other Names: TAS-120
Experimental: Futibatinib (Cohort 2); Participants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Drug: Futibatinib; Futibatinib 20mg once daily on a 28-day cycle; Other Names: TAS-120
Experimental: Futibatinib (Cohort 3); Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Drug: Futibatinib; Futibatinib 20mg once daily on a 28-day cycle; Other Names: TAS-120
Experimental: Futibatinib Plus Fulvestrant (Cohort 4); Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) - Cohorts 1, 2	ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.	At the end of every 2 cycles until disease progression (up to 40 months)
Clinical Benefit Rate (CBR) - Cohort 3	CBR was defined as the percentage of participants with a confirmed response of CR or stable disease (SD) lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest	At the end of every 2 cycles until disease progression (up to 40 months)
6-month Progression-free Survival (PFS) Rate - Cohort 4	The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place.	At the end of every 2 cycles until disease progression (up to 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate - Cohort 3	CR rate was defined as the percentage of participants who achieved CR. CR was defined as disappearance of all targets. Any pathological lymph node must have reduction in short axis to <10 mm. Percentages were rounded off to the nearest single decimal place.	At the end of every 2 cycles until disease progression (up to 40 months)
Overall Response Rate (ORR) - Cohort 4	ORR was defined as the percentage of participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.	At the end of every 2 cycles until disease progression (up to 40 months)
Clinical Benefit Rate (CBR) - Cohort 1,2, and 4	CBR was defined as the percentage of participants with a confirmed response of CR, PR or SD lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest single decimal place.	At the end of every 2 cycles until disease progression (up to 40 months)
6-month PFS Rate - Cohorts 1,2, and 3	The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place.	At the end of every 2 cycles until disease progression (up to 6 months)
Progression Free Survival (PFS)	PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression based on investigator assessment, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.	At the end of every 2 cycles until disease progression (up to 40 months)
Duration of Response (DOR)	DOR was defined as the time from the first documentation of objective response to the to the date of death (any cause) or disease progression, based on Investigator assessment, whichever occurs first. Objective response was defined as participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.	At the end of every 2 cycles until disease progression (up to 40 months)
Overall Survival (OS)	OS was defined as the time (in months) from the date of first dose of the study drug to the date of death. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure.	Up to 40 months
Number of Participants With Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug.	From the first dose of study drug up to 30 days after the last dose (Up to 40 months)
Number of Participants With Dose Limiting Toxicities (DLTs) - Cohort 4	A DLT was defined as any AE that occurs during Cycle 1 that is not clearly attributable to an extraneous cause, such as an underlying disease, occurring in Cycle 1, and meeting at least one of the criteria defined in the protocol. An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug.	Cycle 1 (cycle length= 28 days)

Collaborators and Investigators

• Sponsor: Taiho Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Metastatic Breast Cancer; FGFR; Futibatinib; TAS-120
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant; futibatinib
• Other Study ID Numbers: FOENIX-MBC2 TAS-120-201; 2019-001164-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No