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    Clinical Trial Results:
    HER2-PET as a diagnostic tool in breast cancer patients with a clinical dilemma

    Summary
    EudraCT number
    		 2012-003789-41
    Trial protocol
    		 NL  
    Global end of trial date
    14 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Oct 2022
    First version publication date
    12 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Her2.5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01832051
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands, 9713 GZ
    Public contact
    CP. Schröder, University Medical Center Groningen, 0031 503612821, c.p.schroder@umcg.nl
    Scientific contact
    CP. Schröder, University Medical Center Groningen, 0031 503612821, c.p.schroder@umcg.nl
    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
    14 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the contribution of HER2-PET to subsequent anti-HER2-therapy decisions, in patients suspected of metastatic or locally recurrent HER2-positive breast cancer, with a clinical dilemma defined as failure of standard work up to evaluate the HER2 receptor status of their disease.
    Protection of trial subjects
    To gain additional information on which adjustment of anti-HER2 therapy might be based, patients will make 4 extra visits to the clinic, including blood sampling, tracer injection and a HER2-PET scan implementing a radiation burden of approximately 20 mSv.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2013
    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
    Netherlands: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    19
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening visit - Screening of patient, informed consent, collection of information - Collection of patient characteristics, physical examination - Blood sampling for routine hematology and biochemistry; for women of childbearing potential a pregnancy test will be performed

    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
    		 HER2-PET
    Arm description
    		 Injection of 89Zr-trastuzumab followed by PET scan
    Arm type
    		 Experimental

    Investigational medicinal product name
    89Zr-SUCDF-trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 Ci curie(s) total

    Number of subjects in period 1
    		HER2-PET
    Started
    20
    Completed
    20

    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
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 19 19
        From 65-84 years
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    HER2-PET
    Reporting group description
    		 Injection of 89Zr-trastuzumab followed by PET scan

    Primary: Concordance between HER2-PET results and anti-HER2 therapy

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    End point title
    		 Concordance between HER2-PET results and anti-HER2 therapy [1]
    End point description
    Concordance between HER2-PET results and anti-HER2 therapy is defined as HER2 positive lesion(s) on HER2-PET and subsequent anti-HER2 therapy; or no HER2 positive lesions on HER2-PET and no subsequent anti-HER2 therapy. It is considered a clinically relevant contribution of HER2-PET to anti-HER2-therapy decisions if there is a concordance in at least 2/3 of included patients.
    End point type
    Primary
    End point timeframe
    about 2 years (end of study)
    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: descriptive statistics
    End point values
    		 HER2-PET
    Number of subjects analysed
    20
    Units: SUV
    20
    No statistical analyses for this end point

    Secondary: Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician

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    End point title
    		 Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician
    End point description
    Correlation of HER2-PET result (assessed about 1 week after scan) and questionnaire results (before, directly after, and 3 months after scan)
    End point type
    Secondary
    End point timeframe
    about 2 years (end of study)
    End point values
    		 HER2-PET
    Number of subjects analysed
    20
    Units: SUV
    20
    No statistical analyses for this end point

    Secondary: Correlation of HER2-PET results with standard conventional work-up

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    End point title
    		 Correlation of HER2-PET results with standard conventional work-up
    End point description
    Correlation of HER2-PET result (assessed about 1 week after scan) and standard conventional work-up (assessed before/at screening)
    End point type
    Secondary
    End point timeframe
    about 2 years (end of study)
    End point values
    		 HER2-PET
    Number of subjects analysed
    20
    Units: SUV
    20
    No statistical analyses for this end point

    Secondary: Correlation of HER2-PET results and HER-2 expression by CTCs

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    End point title
    		 Correlation of HER2-PET results and HER-2 expression by CTCs
    End point description
    Correlation of HER2-PET result (assessed about 1 week after scan) and HER-2 expression by CTCs (blood for CTC analysis will be drawn at day of tracer injection, analysis within 3 days)
    End point type
    Secondary
    End point timeframe
    about 2 years (end of study)
    End point values
    		 HER2-PET
    Number of subjects analysed
    20
    Units: SUV
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    within 15 days after the sponsor has first knowledge of the adverse reactions.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Frequency threshold for reporting non-serious adverse events: 2%
    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: no adverse events observed

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2014
    new version IMPD, administrative change patient information
    10 Nov 2014
    - update participating center - update cold dose Trastuzumab - Update IMPD 89Zr-sucDF-trastuzumab

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30058029
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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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