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

Primary Purpose

Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Futibatinib
Futibatinib plus Fulvestrant
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Futibatinib, Metastatic Breast Cancer, FGFR, TAS-120

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic - AZ
  • USCF
  • Florida Cancer Specialists
  • Mayo Clinic - FL
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Moffitt Cancer Center
  • Florida Cancer Specialists
  • Massachusetts General Hospital
  • BIDMC
  • Dana Farber Cancer Institute
  • Mayo Clinic - MN
  • HCA Midwest Health
  • Tennessee Oncology
  • Tennessee Oncology
  • UT Southwestern
  • MD Anderson
  • Tom Baker Cancer Center
  • SunnyBrook Health Sciences
  • Institut Gustave Roussy
  • Centre Leon Berard
  • AOU Policlinico - Vittorio Emanuele
  • Istituto Europeo Di Oncologia - IEO
  • AOU Modena Policlinico
  • Ospedale E. Agnelli
  • Azienda Ospedaliero Universitaria Pisana
  • Istituto Nazionale Tumori Regina Elena
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Centro Hospitalar Universitario Lisboa Norte
  • Porto University
  • Instituto Portugues de Oncologia do Porto
  • Vall d'Hebron
  • University Gregorio Marañon
  • START Madrid - CIOCC
  • HCA Healthcare UK
  • The Christie NHS Foundation Trust
  • The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Futibatinib

Futibatinib plus Fulvestrant

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) - Cohorts 1, 2
Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
Clinical Benefit Rate (CBR) - Cohort 3
CBR is defined as the proportion of patients with a confirmed response of CR or SD lasting at least 24 weeks
6-month Progression-free Survival (PFS) rate - Cohort 4
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

Secondary Outcome Measures

Complete Response (CR) - Cohort 3
CR is defined as the disappearance of all target and/or non-target lesions
Overall Response Rate (ORR) - Cohort 4
Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
Clinical Benefit Rate (CBR) - Cohort 1,2, and 4
CBR is defined as the proportion of patient with a confirmed response of CR, PR or SD lasting at least 24 weeks
6-month Progression-free Survival (PFS) rate - Cohorts 1-3
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
Progression-free Survival (PFS)
PFS is defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression
Duration of Response (DOR)
DOR is defined as the time from first documentation of objective response to the date of death (any cause) or disease progression
Overall Survival (OS)
OS is defined as the time (in months) from the first dose of study therapy to the date of death (any cause)
Number of Adverse Events (AEs) Related to TAS-120 as a monotherapy and in combination with Fulvestrant
Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed
Number of Adverse Events (AEs) Related to Futibatinib as a monotherapy and in combination with Fulvestrant
Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed using Common Terminology Criteria for Adverse Events (CTCAE - Version 5).

Full Information

First Posted
June 24, 2019
Last Updated
August 18, 2023
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04024436
Brief Title
A Study of TAS-120 in Patients With Metastatic Breast Cancer
Official Title
A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification
Keywords
Futibatinib, Metastatic Breast Cancer, FGFR, TAS-120

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Futibatinib
Arm Type
Experimental
Arm Description
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
Arm Title
Futibatinib plus Fulvestrant
Arm Type
Experimental
Arm Description
Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification
Intervention Type
Drug
Intervention Name(s)
Futibatinib
Other Intervention Name(s)
TAS-120
Intervention Description
Futibatinib 20mg once daily on a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Futibatinib plus Fulvestrant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) - Cohorts 1, 2
Description
Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
Time Frame
12 months (estimated)
Title
Clinical Benefit Rate (CBR) - Cohort 3
Description
CBR is defined as the proportion of patients with a confirmed response of CR or SD lasting at least 24 weeks
Time Frame
12 months (estimated)
Title
6-month Progression-free Survival (PFS) rate - Cohort 4
Description
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
Time Frame
12 months (estimated)
Secondary Outcome Measure Information:
Title
Complete Response (CR) - Cohort 3
Description
CR is defined as the disappearance of all target and/or non-target lesions
Time Frame
12 months (estimated)
Title
Overall Response Rate (ORR) - Cohort 4
Description
Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
Time Frame
12 months (estimated)
Title
Clinical Benefit Rate (CBR) - Cohort 1,2, and 4
Description
CBR is defined as the proportion of patient with a confirmed response of CR, PR or SD lasting at least 24 weeks
Time Frame
12 months
Title
6-month Progression-free Survival (PFS) rate - Cohorts 1-3
Description
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
Time Frame
12 months
Title
Progression-free Survival (PFS)
Description
PFS is defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression
Time Frame
12 months
Title
Duration of Response (DOR)
Description
DOR is defined as the time from first documentation of objective response to the date of death (any cause) or disease progression
Time Frame
12 months
Title
Overall Survival (OS)
Description
OS is defined as the time (in months) from the first dose of study therapy to the date of death (any cause)
Time Frame
12 months
Title
Number of Adverse Events (AEs) Related to TAS-120 as a monotherapy and in combination with Fulvestrant
Description
Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed
Time Frame
12 months
Title
Number of Adverse Events (AEs) Related to Futibatinib as a monotherapy and in combination with Fulvestrant
Description
Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed using Common Terminology Criteria for Adverse Events (CTCAE - Version 5).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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: 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
Facility Information:
Facility Name
Mayo Clinic - AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
USCF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mayo Clinic - FL
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
BIDMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic - MN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HCA Midwest Health
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Tennessee Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Tom Baker Cancer Center
City
Calgary
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
SunnyBrook Health Sciences
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
AOU Policlinico - Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Istituto Europeo Di Oncologia - IEO
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
AOU Modena Policlinico
City
Modena
Country
Italy
Facility Name
Ospedale E. Agnelli
City
Pinerolo
ZIP/Postal Code
10064
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Centro Hospitalar Universitario Lisboa Norte
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Porto University
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
START Madrid - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
HCA Healthcare UK
City
London
State/Province
England
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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