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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024436
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer FGFR 1 High Amplification FGFR2 Amplification Drug: Futibatinib Drug: Futibatinib plus Fulvestrant Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Futibatinib

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

 Drug: Futibatinib
Futibatinib 20mg once daily on a 28 day cycle
Other Name: TAS-120
Experimental: Futibatinib plus Fulvestrant
Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification
 Drug: Futibatinib
Futibatinib 20mg once daily on a 28 day cycle
Other Name: TAS-120

Drug: Futibatinib plus Fulvestrant
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.


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) - Cohorts 1, 2 [ Time Frame: 12 months (estimated) ]
    Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors

  2. Clinical Benefit Rate (CBR) - Cohort 3 [ Time Frame: 12 months (estimated) ]
    CBR is defined as the proportion of patients with a confirmed response of CR or SD lasting at least 24 weeks

  3. 6-month Progression-free Survival (PFS) rate - Cohort 4 [ Time Frame: 12 months (estimated) ]
    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 :
  1. Complete Response (CR) - Cohort 3 [ Time Frame: 12 months (estimated) ]
    CR is defined as the disappearance of all target and/or non-target lesions

  2. Overall Response Rate (ORR) - Cohort 4 [ Time Frame: 12 months (estimated) ]
    Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors

  3. Clinical Benefit Rate (CBR) - Cohort 1,2, and 4 [ Time Frame: 12 months ]
    CBR is defined as the proportion of patient with a confirmed response of CR, PR or SD lasting at least 24 weeks

  4. 6-month Progression-free Survival (PFS) rate - Cohorts 1-3 [ Time Frame: 12 months ]
    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

  5. Progression-free Survival (PFS) [ Time Frame: 12 months ]
    PFS is defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression

  6. Duration of Response (DOR) [ Time Frame: 12 months ]
    DOR is defined as the time from first documentation of objective response to the date of death (any cause) or disease progression

  7. Overall Survival (OS) [ Time Frame: 12 months ]
    OS is defined as the time (in months) from the first dose of study therapy to the date of death (any cause)

  8. Number of Adverse Events (AEs) Related to TAS-120 as a monotherapy and in combination with Fulvestrant [ Time Frame: 12 months ]
    Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed

  9. Number of Adverse Events (AEs) Related to Futibatinib as a monotherapy and in combination with Fulvestrant [ Time Frame: 12 months ]
    Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed using Common Terminology Criteria for Adverse Events (CTCAE - Version 5).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024436


Locations
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Sponsors and Collaborators
Taiho Oncology, Inc.
More Information
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04024436    
Other Study ID Numbers: FOENIX-MBC2 TAS-120-201
2019-001164-30 ( EudraCT Number )
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
Futibatinib
Metastatic Breast Cancer
FGFR
TAS-120
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Futibatinib
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs