Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase II study of irinotecan weekly in combination with trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1”

    Summary
    EudraCT number
    		 2012-002347-23
    Trial protocol
    		 DK  
    Global end of trial date
    16 Sep 2015

    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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MA1213
    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
    Dep. of Oncology, Herlev Hospital, 0045 38686472, iben.kumler@regionh.dk
    Scientific contact
    Dep. 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
    16 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Response rate and 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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    1
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment was open at 6 sites in Denmark from October 2012 til September 2015. 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, positive for Her2 and increased copy number of topoisomerase 1 gene. Measurable disease according to RECIST 1.1, Max 3 (after amendment 4) 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 + Trastuzumab
    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.

    Investigational medicinal product name
    Herceptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg on day 1, followed by 6 mg/kg every 3 weeks

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

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 2 2
    Age continuous
    Units: years
        median (full range (min-max))
    		 65 (55 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Irinotecan + Trastuzumab

    Primary: Clinical Benefit Rate

    		 Close Top of page
    End point title
    		 Clinical Benefit Rate [1]
    End point description
    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 du to low number of patients
    End point values
    		 Study treatment
    Number of subjects analysed
    3
    Units: number of patients
        Clinical benefit
    1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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 + Trastuzumab

    Serious adverse events
    		 Study treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    2 / 2
         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
    3 / 3 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    4
    weight loss
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    6
    Mucositis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Erysipelas
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Candida infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Abscess
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    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.

    European Medicines Agency © 1995-Sat Nov 01 00:22:03 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA