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    Clinical Trial Results:
    A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

    Summary
    EudraCT number
    		 2019-001164-30
    Trial protocol
    		 GB   PT   ES   IT  
    Global end of trial date
    06 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2025
    First version publication date
    14 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAS-120-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04024436
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Taiho Oncology, Inc.
    Sponsor organisation address
    101 Carnegie Center, Suite 101, Princeton, United States, NJ 08540
    Public contact
    Senior Study Manager, Taiho Oncology, Inc., +1 844-878-2446, medicalinformation@taihooncology.com
    Scientific contact
    Senior Study Manager, Taiho Oncology, Inc., +1 844-878-2446, medicalinformation@taihooncology.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the anti-tumor activity of TAS-120 as monotherapy or in combination with fulvestrant in the treatment of subjects with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    United States: 35
    Worldwide total number of subjects
    64
    EEA total number of subjects
    18
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    52
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study from 28 January 2020 to 06 September 2023.

    Pre-assignment
    Screening details
    		 A total of 64 subjects were enrolled in either Cohorts 1, 2 or 3 to receive futibatinib or to Cohort 4 to receive futibatinib plus fulvestrant.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Futibatinib (Cohort 1)
    Arm description
    		 Subjects 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    Other name
    TAS-120
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib administered as 20mg oral tablets once daily for a continuous 28-day cycle.

    Arm title
    		 Futibatinib (Cohort 2)
    Arm description
    		 Subjects 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    Other name
    TAS-120
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib administered as 20mg oral tablets once daily for a continuous 28-day cycle.

    Arm title
    		 Futibatinib (Cohort 3)
    Arm description
    		 Subjects with advanced or metastatic HR+, HER2- or TNBC, breast cancer 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    Other name
    TAS-120
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib administered as 20mg oral tablets once daily for a continuous 28-day cycle.

    Arm title
    		 Futibatinib Plus Fulvestrant (Cohort 4)
    Arm description
    		 Subjects 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    Other name
    TAS-120
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib administered as 20mg oral tablets once daily for a continuous 28-day cycle.

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Fulvestrant administered as 500 mg IM injection on Days 1 and 15 of Cycle 1, then Day 1 of every subsequent 28-day cycle.

    Number of subjects in period 1
    		Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Started
    17
    21
    4
    22
    Completed
    0
    0
    0
    0
    Not completed
    17
    21
    4
    22
         Death
    10
    14
    2
    7
         Reason Not Specified
    -
    1
    -
    2
         Withdrawal of consent
    2
    -
    -
    1
         Study termination by sponsor
    4
    6
    2
    11
         Loss to follow up
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Futibatinib (Cohort 1)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Futibatinib (Cohort 2)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Futibatinib (Cohort 3)
    Reporting group description
    		 Subjects with advanced or metastatic HR+, HER2- or TNBC, breast cancer 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.

    Reporting group title
    Futibatinib Plus Fulvestrant (Cohort 4)
    Reporting group description
    		 Subjects 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.

    Reporting group values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4) Total
    Number of subjects
    		 17 21 4 22 64
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.8 ( 11.42 ) 51.4 ( 14.50 ) 60.8 ( 5.74 ) 52.7 ( 12.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 21 4 22 64
        Male
    		 0 0 0 0 0
    Ethinicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 2 4
        Not Hispanic or Latino
    		 15 15 4 13 47
        Unknown or Not Reported
    		 1 5 0 7 13
    Race
    Units: Subjects
        Caucasian/White
    		 14 12 4 16 46
        Black or African American
    		 2 1 0 1 4
        Asian
    		 1 0 0 1 2
        American Indian or Alaskan Native
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 0 1
        Unknown
    		 0 7 0 4 11

    End points

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    End points reporting groups
    Reporting group title
    Futibatinib (Cohort 1)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Futibatinib (Cohort 2)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Futibatinib (Cohort 3)
    Reporting group description
    		 Subjects with advanced or metastatic HR+, HER2- or TNBC, breast cancer 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.

    Reporting group title
    Futibatinib Plus Fulvestrant (Cohort 4)
    Reporting group description
    		 Subjects 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.

    Primary: Objective Response Rate (ORR) - Cohorts 1, 2

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    End point title
    		 Objective Response Rate (ORR) - Cohorts 1, 2 [1] [2]
    End point description
    ORR was defined as the percentage of subjects 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. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics is provided for this end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 1 and 2 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2)
    Number of subjects analysed
    17 [3]
    21
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0 to 19.5)
    9.5 (1.2 to 30.4)
    Notes
    [3] - No subjects achieved response.
    No statistical analyses for this end point

    Primary: Clinical Benefit Rate (CBR) - Cohort 3

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    End point title
    		 Clinical Benefit Rate (CBR) - Cohort 3 [4] [5]
    End point description
    CBR was defined as the percentage of subjects with confirmed CR or SD lasting ≥24 weeks by Investigator assessment. CR: disappearance of all target lesions, with any pathological lymph node reduced to <10 mm short axis. SD: neither sufficient shrinkage for PR nor sufficient increase for PD, referencing the smallest sum diameters on study. PR: ≥30% decrease in sum of target lesion diameters from baseline. PD: ≥20% increase in sum diameters from the smallest on study (including baseline), plus ≥5 mm absolute increase, or new lesions. Percentages were rounded off to the nearest single decimal place. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics is provided for this end point.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 3 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib (Cohort 3)
    Number of subjects analysed
    4
    Units: percentage of subjects
        number (confidence interval 95%)
    50.0 (6.8 to 93.2)
    No statistical analyses for this end point

    Primary: 6-month Progression-free Survival (PFS) Rate - Cohort 4

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    End point title
    		 6-month Progression-free Survival (PFS) Rate - Cohort 4 [6] [7]
    End point description
    The 6-month PFS rate was defined as the proportion percentage of subjects 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. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics is provided for this end point.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    22
    Units: percentage of subjects
        number (confidence interval 95%)
    45.5 (24.4 to 67.8)
    No statistical analyses for this end point

    Secondary: Complete Response (CR) Rate - Cohort 3

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    End point title
    		 Complete Response (CR) Rate - Cohort 3 [8]
    End point description
    CR rate was defined as the percentage of subjects 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. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 3 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib (Cohort 3)
    Number of subjects analysed
    4 [9]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 60.2)
    Notes
    [9] - No subjects achieved response.
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) - Cohort 4

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    End point title
    		 Overall Response Rate (ORR) - Cohort 4 [10]
    End point description
    ORR was defined as the percentage of subjects 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. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    22
    Units: percentage of subjects
        number (confidence interval 95%)
    18.2 (5.2 to 40.3)
    No statistical analyses for this end point

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

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    End point title
    		 Clinical Benefit Rate (CBR) - Cohort 1, 2, and 4 [11]
    End point description
    CBR was defined as the percentage of subjects with confirmed CR or SD lasting ≥24 weeks by Investigator assessment. CR: disappearance of all target lesions, with any pathological lymph node reduced to <10 mm short axis. SD: neither sufficient shrinkage for PR nor sufficient increase for PD, referencing the smallest sum diameters on study. PR: ≥30% decrease in sum of target lesion diameters from baseline. PD: ≥20% increase in sum diameters from the smallest on study (including baseline), plus ≥5 mm absolute increase, or new lesions. Percentages were rounded off to the nearest single decimal place. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 1, 2, and 4 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    17
    21
    22
    Units: percentage of subjects
        number (confidence interval 95%)
    11.8 (1.5 to 36.4)
    23.8 (8.2 to 47.2)
    50.0 (28.2 to 71.8)
    No statistical analyses for this end point

    Secondary: 6-month PFS Rate - Cohorts 1, 2 and 3

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    End point title
    		 6-month PFS Rate - Cohorts 1, 2 and 3 [12]
    End point description
    The 6-month PFS rate was defined as the percentage of subjects 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. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    6 months
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 1, 2 and 3 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3)
    Number of subjects analysed
    17
    21
    4
    Units: percentage of subjects
        number (confidence interval 95%)
    5.9 (0.1 to 28.7)
    19.0 (5.4 to 41.9)
    50.0 (6.8 to 93.2)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    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. ‘9999’ signifies that upper limit of 95% CI was not estimable due to a lack of sufficient number of events within the cohort to estimate the parameter. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    17
    21
    4
    22
    Units: Months
        median (confidence interval 95%)
    3.7 (1.7 to 5.1)
    1.9 (1.6 to 4.0)
    12.4 (1.9 to 9999)
    7.2 (2.1 to 7.6)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    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 subjects 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. All treated population included all enrolled subjects who received at least 1 dose of study drug. Number of subjects analysed are the subjects with data available for analysis.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (up to 40 months)
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    0 [13]
    2
    0 [14]
    4
    Units: months
        median (full range (min-max))
    ( to )
    3.38 (3.1 to 3.7)
    ( to )
    6.34 (3.3 to 16.7)
    Notes
    [13] - No subject had an event
    [14] - No subject had an event
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time (in months) from the date of first dose of the study drug to the date of death. Subjects 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. 999 signifies that upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5
    End point type
    Secondary
    End point timeframe
    Up to 40 months
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    17
    21
    4
    22
    Units: months
        median (confidence interval 95%)
    16.5 (8.1 to 999)
    10.2 (6.1 to 21.8)
    30.4 (12.4 to 999)
    23.9 (20.6 to 999)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs)

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    End point title
    		 Number of Subjects with Adverse Events (AEs)
    End point description
    An AE is defined as any untoward medical occurrence in a clinical study subject and does not necessarily have a causal relationship with the study drug. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 30 days after the last dose (Up to 40 months).
    End point values
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    17
    21
    4
    22
    Units: Count of subjects
        number (not applicable)
    17
    21
    4
    22
    No statistical analyses for this end point

    Secondary: Number of Subjects With Dose Limiting Toxicities (DLTs) – Cohort 4

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    End point title
    		 Number of Subjects With Dose Limiting Toxicities (DLTs) – Cohort 4 [15]
    End point description
    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 subjects and does not necessarily have a causal relationship with the study drug. All treated population included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (up to 28 days)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP.
    End point values
    		 Futibatinib Plus Fulvestrant (Cohort 4)
    Number of subjects analysed
    22
    Units: Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 30 days after the last dose (Up to 40 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Futibatinib (Cohort 1)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Futibatinib (Cohort 2)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Futibatinib (Cohort 3)
    Reporting group description
    		 Subjects with advanced or metastatic HR+, HER2- or TNBC, breast cancer 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.

    Reporting group title
    Futibatinib Plus Fulvestrant (Cohort 4)
    Reporting group description
    		 Subjects 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.

    Serious adverse events
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 21 (23.81%)
    1 / 4 (25.00%)
    4 / 22 (18.18%)
         number of deaths (all causes)
    10
    14
    2
    7
         number of deaths resulting from adverse events
    2
    2
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute promyelocytic leukaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion malignant
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic ischaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Futibatinib (Cohort 1) Futibatinib (Cohort 2) Futibatinib (Cohort 3) Futibatinib Plus Fulvestrant (Cohort 4)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 17 (94.12%)
    21 / 21 (100.00%)
    4 / 4 (100.00%)
    22 / 22 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 17 (23.53%)
    7 / 21 (33.33%)
    3 / 4 (75.00%)
    7 / 22 (31.82%)
         occurrences all number
    4
    8
    3
    7
    Asthenia
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    3
    0
    3
    Mucosal inflammation
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Malaise
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Reproductive system and breast disorders
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    7 / 17 (41.18%)
    5 / 21 (23.81%)
    0 / 4 (0.00%)
    11 / 22 (50.00%)
         occurrences all number
    9
    5
    0
    11
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 17 (23.53%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    13 / 22 (59.09%)
         occurrences all number
    5
    2
    0
    20
    Weight decreased
         subjects affected / exposed
    4 / 17 (23.53%)
    4 / 21 (19.05%)
    1 / 4 (25.00%)
    6 / 22 (27.27%)
         occurrences all number
    4
    5
    1
    6
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 21 (14.29%)
    1 / 4 (25.00%)
    6 / 22 (27.27%)
         occurrences all number
    2
    3
    1
    7
    Blood bilirubin increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    0
    2
    Blood creatinine increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    5
    0
    2
    White blood cell count decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Blood phosphorus increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Computerised tomogram abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    2 / 4 (50.00%)
    5 / 22 (22.73%)
         occurrences all number
    1
    0
    2
    5
    Headache
         subjects affected / exposed
    4 / 17 (23.53%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    4
    2
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    0
    1
    3
    Taste disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    1
    0
    2
    Neuropathy peripheral
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    0
    0
    3
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    Seizure
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    Tremor
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Epilepsy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Migraine
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Parosmia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 21 (23.81%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    4
    5
    0
    3
    Neutropenia
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    0
    2
    Lymph node pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 17 (11.76%)
    5 / 21 (23.81%)
    2 / 4 (50.00%)
    7 / 22 (31.82%)
         occurrences all number
    2
    5
    2
    7
    Ocular hyperaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Vitreous floaters
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Central serous chorioretinopathy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Corneal disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Growth of eyelashes
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 17 (47.06%)
    9 / 21 (42.86%)
    1 / 4 (25.00%)
    13 / 22 (59.09%)
         occurrences all number
    8
    9
    1
    13
    Diarrhoea
         subjects affected / exposed
    4 / 17 (23.53%)
    8 / 21 (38.10%)
    1 / 4 (25.00%)
    10 / 22 (45.45%)
         occurrences all number
    4
    12
    1
    18
    Nausea
         subjects affected / exposed
    7 / 17 (41.18%)
    6 / 21 (28.57%)
    0 / 4 (0.00%)
    9 / 22 (40.91%)
         occurrences all number
    7
    8
    0
    9
    Dry mouth
         subjects affected / exposed
    5 / 17 (29.41%)
    4 / 21 (19.05%)
    1 / 4 (25.00%)
    10 / 22 (45.45%)
         occurrences all number
    5
    4
    1
    10
    Vomiting
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 21 (19.05%)
    1 / 4 (25.00%)
    7 / 22 (31.82%)
         occurrences all number
    4
    8
    1
    7
    Abdominal pain
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    4 / 22 (18.18%)
         occurrences all number
    3
    1
    1
    5
    Stomatitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    4 / 22 (18.18%)
         occurrences all number
    1
    1
    1
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    5 / 22 (22.73%)
         occurrences all number
    1
    0
    0
    6
    Dyspepsia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    3
    0
    2
    Dysphagia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    1
    Oral pain
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 17 (23.53%)
    3 / 21 (14.29%)
    1 / 4 (25.00%)
    13 / 22 (59.09%)
         occurrences all number
    4
    3
    1
    13
    Dry skin
         subjects affected / exposed
    3 / 17 (17.65%)
    6 / 21 (28.57%)
    0 / 4 (0.00%)
    5 / 22 (22.73%)
         occurrences all number
    3
    6
    0
    5
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    5 / 22 (22.73%)
         occurrences all number
    2
    1
    1
    5
    Onycholysis
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    0
    3
    Pruritus
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 21 (4.76%)
    2 / 4 (50.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    2
    1
    Nail disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    1
    1
    2
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    1
    0
    3
    Nail discolouration
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nail dystrophy
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Pain of skin
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dermal cyst
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Onychomadesis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 21 (19.05%)
    2 / 4 (50.00%)
    7 / 22 (31.82%)
         occurrences all number
    2
    5
    2
    8
    Muscle spasms
         subjects affected / exposed
    3 / 17 (17.65%)
    3 / 21 (14.29%)
    2 / 4 (50.00%)
    3 / 22 (13.64%)
         occurrences all number
    4
    3
    2
    3
    Back pain
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    1 / 4 (25.00%)
    4 / 22 (18.18%)
         occurrences all number
    1
    2
    1
    4
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 21 (19.05%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    4
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    0
    1
    4
    Flank pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Pain in jaw
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Spinal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    2
    0
    0
    COVID-19
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    2
    Eye infection
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Erysipelas
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes simplex reactivation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    13 / 17 (76.47%)
    18 / 21 (85.71%)
    3 / 4 (75.00%)
    21 / 22 (95.45%)
         occurrences all number
    14
    27
    4
    35
    Decreased appetite
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 21 (19.05%)
    1 / 4 (25.00%)
    7 / 22 (31.82%)
         occurrences all number
    2
    4
    1
    7
    Hypercalcaemia
         subjects affected / exposed
    3 / 17 (17.65%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    3
    3
    0
    3
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    2
    0
    0
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 21 (14.29%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    5
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    7
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral dysaesthesia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jun 2019
    The following changes were made as per amendment 1: 1.Added plasma sample collection for PopPK analyses; this included the addition of a corresponding exploratory objective. 2. Added of Section describing collection and analysis of samples, and additions / amendments to the statistical methods defining the PopPK analysis set and discussing analysis and summarization of data. 3. Updated inclusion Criterion with several clarifications related to permitted prior therapies. 4. Increased the required duration of contraception to 1 year after last dose of fulvestrant. 5. The definition of a DLT was modified per regulatory feedback. 6. Specified that for Cohort 4, in cases where toxicity is not clearly attributable to either study drug, TAS-120 will be modified or discontinued first.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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