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    Clinical Trial Results:
    LISAH: AN OPEN-LABEL, RANDOMISED PHASE II STUDY ASSESSING QUALITY OF LIFE ASSOCIATED WITH SUBCUTANEOUS TRASTUZUMAB INJECTED INTO THE THIGH OR UPPER ARM IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER

    Summary
    EudraCT number
    2013-001023-39
    Trial protocol
    AT  
    Global end of trial date
    18 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    04 May 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ML28786
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01928615
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    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
    18 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the Quality of Life in Human Epidermal Growth Factor 2 (HER2) - positive early breast cancer patients treated with trastuzumab solution injected subcutaneously into the thigh versus upper arm.
    Protection of trial subjects
    This study will be conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Sep 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
    Austria: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Neither of the 2 enrolled participants were randomized to 1 of the 2 crossover treatment arms. Randomization would not have occurred until after Cycle 6. Both participants only received 1 cycle of treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Trastuzumab
    Arm description
    In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
    Arm type
    Experimental

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    8 mg/kg loading dose in Cycle1 followed by 6 mg/kg maintenance dose from Cycle 2 to Cycle 6 (3-week cycles) administered intravenously. A 600 mg subcutaneous injection from Cycle 7 to Cycle 18.

    Number of subjects in period 1
    Trastuzumab
    Started
    2
    Completed
    0
    Not completed
    2
         Study terminated by Sponsor
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).

    Reporting group values
    Overall Study Total
    Number of subjects
    2 2
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38 ± 14.14 -
    Gender categorical
    Units: Subjects
        Female
    2 2
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Trastuzumab
    Reporting group description
    In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).

    Primary: Quality of Life Score

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    End point title
    Quality of Life Score [1]
    End point description
    Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.
    End point type
    Primary
    End point timeframe
    Cycles 7-14 (Weeks 19-42, 24 weeks total)
    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: Since the study was terminated by the sponsor, endpoints were not analyzed and no statistical analyses were performed.
    End point values
    Trastuzumab
    Number of subjects analysed
    0 [2]
    Units: participants
        number (not applicable)
    Notes
    [2] - Due to premature termination of the study, the Outcome Measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    Overall survival was defined as the time in months from Baseline to death from any cause.
    End point type
    Secondary
    End point timeframe
    Baseline to the end of the study (up to 54 weeks)
    End point values
    Trastuzumab
    Number of subjects analysed
    0 [3]
    Units: participants
        number (not applicable)
    Notes
    [3] - Due to premature termination of the study, the Outcome Measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Disease-free Survival

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    End point title
    Disease-free Survival
    End point description
    Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    Baseline to the end of the study (up to 54 weeks)
    End point values
    Trastuzumab
    Number of subjects analysed
    0 [4]
    Units: participants
        number (not applicable)
    Notes
    [4] - Due to premature termination of the study, the Outcome Measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Health Care Provider’s Satisfaction With the Injection Site

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    End point title
    Health Care Provider’s Satisfaction With the Injection Site
    End point description
    The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.
    End point type
    Secondary
    End point timeframe
    End of Cycles 10 and 14 (Weeks 30 and 42)
    End point values
    Trastuzumab
    Number of subjects analysed
    0 [5]
    Units: participants
        number (not applicable)
    Notes
    [5] - Due to premature termination of the study, the Outcome Measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Participant’s Satisfaction With the Injection Site

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    End point title
    Participant’s Satisfaction With the Injection Site
    End point description
    Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.
    End point type
    Secondary
    End point timeframe
    End of Cycles 10 and 14 (Weeks 30 and 42)
    End point values
    Trastuzumab
    Number of subjects analysed
    0 [6]
    Units: participants
        number (not applicable)
    Notes
    [6] - Due to premature termination of the study, the Outcome Measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Preferring Each Injection Site

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    End point title
    Percentage of Participants Preferring Each Injection Site
    End point description
    Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.
    End point type
    Secondary
    End point timeframe
    End of Cycle 14 (Week 42)
    End point values
    Trastuzumab
    Number of subjects analysed
    0 [7]
    Units: participants
        number (not applicable)
    Notes
    [7] - Due to premature termination of the study, the Outcome Measure was not analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of first dose of study drug administration until study termination.
    Adverse event reporting additional description
    Intent-to-treat population: All participants who received at least 1 dose of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Trastuzumab
    Reporting group description
    In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).

    Serious adverse events
    Trastuzumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Trastuzumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    Respiratory, thoracic and mediastinal disorders
    Common cold
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1

    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? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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