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    Clinical Trial Results:
    Evaluation of the impact of a Sandostatin injection before axillary node dissection on lymphorrhea in patients operated for breast cancer

    Summary
    EudraCT number
    		 2015-004337-27
    Trial protocol
    		 FR  
    Global end of trial date
    25 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2022
    First version publication date
    23 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICO-A-2015-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03791736
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Cancérologie de l'Ouest
    Sponsor organisation address
    15 rue André Boquel, ANGERS, France, 49055
    Public contact
    Marine TIGREAT, Institut de Cancérologie de l'Ouest, 0033 240679878, marine.tigreat@ico.unicancer.fr
    Scientific contact
    Marine TIGREAT, Institut de Cancérologie de l'Ouest, 0033 240679878, marine.tigreat@ico.unicancer.fr
    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
    20 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective is to reduce by 50% the incidence of lymphorrhea (change from 30% to 15%) following axillary node dissection in patients operated for breast cancer (without mastectomy) pre-treated with an injection of Sandostatine®.
    Protection of trial subjects
    In order to ensure the protection of the rights and the safety of trial subjects, this clinical trial was performed in compliance with the principles laid down in the declaration oh Helsinki, good clinical pratice and European regulation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2016
    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
    France: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion must be made at least 3 days before the planned date of surgery (elective axillary dissection). After checking the inclusion and non-inclusion criteria and signing the consent, inclusion will be done directly online via the e-CRF. The patient number will be incremented automatically.

    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
    		 Sandostatine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octréotide acétate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection of sandostatin 30 mg 3 days before surgery

    Number of subjects in period 1
    		Sandostatine
    Started
    4
    Completed
    4

    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
    		 4 4
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Sandostatine
    Reporting group description
    		 -

    Primary: Number of patients who had at least one lymphocele requiring an evacuation puncture

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    End point title
    		 Number of patients who had at least one lymphocele requiring an evacuation puncture [1]
    End point description
    End point type
    Primary
    End point timeframe
    2 months after surgery
    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: The study was stopped prematurely after the inclusion of 4 patients. No analysis was performed
    End point values
    		 Sandostatine
    Number of subjects analysed
    4
    Units: Patient
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events have been reported from inclusion until 2 months after product administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC AE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Axillary dissection
    Reporting group description
    		 -

    Serious adverse events
    		 Axillary dissection
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Axillary dissection
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    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: I confirm that there was not adverses events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2017
    Update of the list of investigators

    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 trial ended prematurely after the inclusion of 4 patients. No statistical analyse could be possible and only a description of population's characteristics has been realized
    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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