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    Clinical Trial Results:
    Phase II study of irinotecan weekly in patients with locally advanced or metastatic HER2-negative breast cancer and increased cancer cell copy number of the topoisomerase 1 gene (TOP1)”

    Summary
    EudraCT number
    		 2012-002348-26
    Trial protocol
    		 DK  
    Global end of trial date
    05 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MA1214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Danish Breast Cancer Group (DBCG)
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Department of Oncology, Herlev Hospital, 0045 38686472, iben.kumler@regionh.dk
    Scientific contact
    Department of Oncology, Herlev Hospital, 0045 38686472, iben.kumler@regionh.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
    12 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1
    Protection of trial subjects
    Eligibility criteria, standard safety monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    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: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    5
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was open at 6 sites in Denmark from October 2012 til July 2016. Patient were recruited from the pool of patients participating in a pre-screening protocol (not part of this trial) that analyses the copy number of topoisomerase 1 gene in patients with metastatic breast cancer.

    Pre-assignment
    Screening details
    		 Patients with metastatic breast cancer, negative for Her2 and increased copy number of topoisomerase 1 gene. Measurable disease according to RECIST 1.1, Max 3 or 4 (after an amendment) lines of chemotherapy for advanced or metastatic disease

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

    Arms
    Arm title
    		 Study treatment
    Arm description
    		 Irinotecan
    Arm type
    		 Experimental

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m2 given weekly for 4 weeks followed by 2 weeks without administration. In case of non-PD this treatment was repeated every 6 weeks.

    Number of subjects in period 1
    		Study treatment
    Started
    9
    Completed
    6
    Not completed
    3
         Adverse event, non-fatal
    2
         Patient wish
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 9 9
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 4 4
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (50 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Irinotecan

    Primary: Clinical Benefit Rate

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    End point title
    		 Clinical Benefit Rate [1]
    End point description
    Patients with SD >= 4 months, PR or CR
    End point type
    Primary
    End point timeframe
    Tumor assessments were done every 6th week
    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: No statistical analyses performed due to low number of patients
    End point values
    		 Study treatment
    Number of subjects analysed
    7 [2]
    Units: number of patients
        Clinical Benefit
    3
    Notes
    [2] - 2 patients were not evaluable
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment start to 28 days after last treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Irinotecan

    Serious adverse events
    		 Study treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 9 (55.56%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Study treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Weight loss
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    13
    Mucositis
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Aug 2013
    Inclusion criteria amendment from maximum of previously 3 lines of treatment for advanced of metastatic disease allowed to maximum of previously 4 lines of treatment for advanced of metastatic disease allowed
    03 Mar 2014
    Starting dose of Irinotecan reduced from 100 mg/m2 to 75 mg/m2

    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.
    slow recruitment, Adequate patient number not reached at premature end of trial

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31196001
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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
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