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

NCT04024436 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: FOENIX-MBC2 TAS-120-2012019-001164-30
• Study Type: interventional
• Target: 64
• Locations: 7 countries
• Sites: 37

Brief 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.

Conditions

Metastatic Breast Cancer; FGFR 1 High Amplification; FGFR2 Amplification

Keywords

Futibatinib; Metastatic Breast Cancer; FGFR; TAS-120

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Complete Response (CR) Rate - Cohort 3

  At the end of every 2 cycles until disease progression (up to 40 months)

• Overall Response Rate (ORR) - Cohort 4

  At the end of every 2 cycles until disease progression (up to 40 months)

• Clinical Benefit Rate (CBR) - Cohort 1,2, and 4

  At the end of every 2 cycles until disease progression (up to 40 months)

• 6-month PFS Rate - Cohorts 1,2, and 3

  At the end of every 2 cycles until disease progression (up to 6 months)

• Progression Free Survival (PFS)

  At the end of every 2 cycles until disease progression (up to 40 months)

Study Arms (4)

Futibatinib (Cohort 1)

EXPERIMENTAL

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 (Cohort 2)

EXPERIMENTAL

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 (Cohort 3)

EXPERIMENTAL

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 Plus Fulvestrant (Cohort 4)

EXPERIMENTAL

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

Interventions

Futibatinib DRUG

Futibatinib 20mg once daily on a 28-day cycle

Also known as: TAS-120

Futibatinib (Cohort 1); Futibatinib (Cohort 2); Futibatinib (Cohort 3)

Futibatinib plus Fulvestrant DRUG

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.

Futibatinib Plus Fulvestrant (Cohort 4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• History and/or current evidence of any of the following disorders:
• Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant
• Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant
• Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant
• 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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (37)

Mayo Clinic - AZ

Phoenix, Arizona, 85054, United States

Location

USCF

San Francisco, California, 94115, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Mayo Clinic - FL

Jacksonville, Florida, 32224, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

Tallahassee, Florida, 32308, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

BIDMC

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic - MN

Rochester, Minnesota, 55905, United States

Location

HCA Midwest Health

Kansas City, Missouri, 64132, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Tom Baker Cancer Center

Calgary, T2N 4N2, Canada

Location

SunnyBrook Health Sciences

Toronto, M4N 3M5, Canada

Location

Institut Gustave Roussy

Villejuif, Cedex, 94805, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

AOU Policlinico - Vittorio Emanuele

Catania, 95123, Italy

Location

Istituto Europeo Di Oncologia - IEO

Milan, 20141, Italy

Location

AOU Modena Policlinico

Modena, Italy

Location

Ospedale E. Agnelli

Pinerolo, 10064, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Centro Hospitalar Universitario Lisboa Norte

Lisbon, 1649-035, Portugal

Location

Porto University

Porto, 4099-001, Portugal

Location

Instituto Portugues de Oncologia do Porto

Porto, 4200-072, Portugal

Location

Vall d'Hebron

Barcelona, 08035, Spain

Location

University Gregorio Marañon

Madrid, 28007, Spain

Location

START Madrid - CIOCC

Madrid, 28050, Spain

Location

HCA Healthcare UK

London, England, W1G 6AD, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, England, M20 4BX, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

futibatinib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

The Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.

Results Point of Contact

• Title: Taiho Oncology, Inc
• Organization: Taiho Oncology, Inc

medicalinformation@taihooncology.com

+1 844-878-2446

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 18, 2019
• Study Start: January 28, 2020
• Primary Completion: May 31, 2023
• Study Completion: September 6, 2023
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3); IT (7); GB (3); FR (2); ES (3); US (17); CA (2)