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    Clinical Trial Results:
    Can Eribulin enhance the effect of subsequent endocrine therapy?- a phase 2 study for patients with ER positive HER2 normal metastatic breast cancer

    Summary
    EudraCT number
    		 2020-004909-32
    Trial protocol
    		 DK  
    Global end of trial date
    26 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2024
    First version publication date
    04 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    5798002749939
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Oncology University Hospital of Aarhus
    Sponsor organisation address
    Palle Juul Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Department of Oncology, Anne Sofie Brems-Eskildsen, 45 24839896, anbrem@onerm.dk
    Scientific contact
    Department of Oncology, Anne Sofie Brems-Eskildsen, 45 24839896, annebrem@rm.dk
    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
    26 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Can we, by 4 series of chemoterapy treatment with Eribulin, enhance the effect of 3. line antiestrogenen treatment with exemestane, as compared to 2 linie anti-estrogene treatment with fulvestrant monoterapy (before entering the study).
    Protection of trial subjects
    good clinical practice
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2021
    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
    Denmark: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    4
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 8 patients were recruited in department of oncology, Aarhus

    Pre-assignment
    Screening details
    		 Patients were included from the Department of Oncology at the University Hospital of Aarhus from 2022 to 2024

    Period 1
    Period 1 title
    study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 singel arm study
    Arm description
    		 -
    Arm type
    		 singel arm

    Investigational medicinal product name
    eribulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    dosed after surface

    Number of subjects in period 1
    		singel arm study
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    study period
    Reporting group description
    		 -

    Reporting group values
    		 study period Total
    Number of subjects
    		 8 8
    Age categorical
    adults
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (53 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    singel arm study
    Reporting group description
    		 -

    Primary: Response of exemestane

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    End point title
    		 Response of exemestane [1]
    End point description
    descriptive analysis
    End point type
    Primary
    End point timeframe
    during the study period
    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: we have only one group in the study. The statisitcal plan was to make af desctiptive analysis
    End point values
    		 singel arm study
    Number of subjects analysed
    8 [2]
    Units: 8
    8
    Notes
    [2] - only 8 patientes included in the study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    no new adverse events were detected in the trial. Both drugs in the study were well known.
    Adverse event reporting additional description
    as no new adverse events were detected the treshold for reporting the AE was not reached.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    4
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: we have no new signal in the study. We saw febrile neutropenia in 3 out of 8 patients as expected with the treatment with Eribulin. More over one patient had liver faliure due to breast cancer progression during the treatment.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Oct 2024
    The trial stopped due to lack of effect in the study population and we only treated 8 out of the planned 42 patientes due to lack of effect
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial were stoped after including 8 out of planed 42 patients due to no responders were seen. And it therefore were considered unlikely that we would get resopnders and effect of the studied startegy.
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    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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