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    Clinical Trial Results:
    An Open-Label, Randomized, Multicenter Phase Iii Study In Patients With Her2-Positive Metastatic Breast Cancer Responding To First Line Treatment With Intravenous Trastuzumab For At Least 3 Years And Investigating Patient Preference For Subcutaneous Trastuzumab

    Summary
    EudraCT number
    		 2012-003442-32
    Trial protocol
    		 FR  
    Global end of trial date
    17 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Aug 2020
    First version publication date
    01 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ML28589
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01810393
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Hoffmann-La Roche, Medical Communications, +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
    04 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This open-label, randomized, multicenter study evaluated subjects preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in subjects with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Subjects were randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All subjects received trastuzumab SC for Cycles 7 to 18.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: ● Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines ● Applicable ICH Good Clinical Practice (GCP) Guidelines ● Applicable laws and regulations
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jun 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 114
    Worldwide total number of subjects
    114
    EEA total number of subjects
    114
    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)
    81
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening period: within 21 days prior to study treatment start (Baseline visit, Day 1), subjects eligibility was determined at the Screening visit. At Baseline visit, patient’s inclusion in the study was established.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Trastuzumab SC then IV
    Arm description
    		 Subjects received treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Subjects continued receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise subjects continued IV treatment) for a total of 18 cycles of treatment during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trastuzumab was administered at a dose of 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trastuzumab was administered at a dose of 6 milligrams per kilogram (mg/kg) IV in 21-day cycles as per schedule described in respective arm.

    Arm title
    		 Trastuzumab IV then SC
    Arm description
    		 Subjects received treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Subjects continued receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise subjects continued IV treatment) for a total of 18 cycles of treatment during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trastuzumab was administered at a dose of 6 milligrams per kilogram (mg/kg) IV in 21-day cycles as per schedule described in respective arm.

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trastuzumab was administered at a dose of 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.

    Number of subjects in period 1
    		Trastuzumab SC then IV Trastuzumab IV then SC
    Started
    57
    57
    Completed
    44
    38
    Not completed
    13
    19
         Consent withdrawn by subject
    4
    4
         Failure to return
    1
    -
         Death
    2
    4
         Unknown reason
    -
    3
         Disease progression/recurrence of disease
    3
    3
         Protocol deviation
    1
    5
         Did not cooperate
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trastuzumab SC then IV
    Reporting group description
    		 Subjects received treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Subjects continued receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise subjects continued IV treatment) for a total of 18 cycles of treatment during the study.

    Reporting group title
    Trastuzumab IV then SC
    Reporting group description
    		 Subjects received treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Subjects continued receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise subjects continued IV treatment) for a total of 18 cycles of treatment during the study.

    Reporting group values
    		 Trastuzumab SC then IV Trastuzumab IV then SC Total
    Number of subjects
    		 57 57 114
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 40 41 81
        From 65-84 years
    		 17 16 33
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 58.23 (37.3 to 82.2) 59.15 (34.7 to 84.9) -
    Gender Categorical
    Units: Subjects
        Female
    		 57 57 114
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Trastuzumab SC Then Trastuzumab IV mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified Intent-to-Treat (m-ITT) population: all subjects from the ITT population who received both routes (SC and IV) during the cross-over period and who completed the last question of the PPQ after the cross-over period

    Subject analysis set title
    Trastuzumab IV Then Trastuzumab SC mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified Intent-to-Treat (m-ITT) population: all subjects from the ITT population who received both routes (SC and IV) during the cross-over period and who completed the last question of the PPQ after the cross-over period

    Subject analysis set title
    Trastuzumab SC Then Trastuzumab IV ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of T SC or T IV during the cross-over period

    Subject analysis set title
    Trastuzumab IV Then Trastuzumab SC ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of T SC or T IV during the cross-over period

    Subject analysis set title
    Trastuzumab SC
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of Trastuzumab SC during the cross-over period.

    Subject analysis set title
    Trastuzumab IV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of Trastuzumab IV during the cross-over period.

    Subject analysis sets values
    		 Trastuzumab SC Then Trastuzumab IV mITT Trastuzumab IV Then Trastuzumab SC mITT Trastuzumab SC Then Trastuzumab IV ITT Trastuzumab IV Then Trastuzumab SC ITT Trastuzumab SC Trastuzumab IV
    Number of subjects
    47
    45
    57
    56
    108
    111
    Age Categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    33
    32
    40
    40
        From 65-84 years
    12
    15
    17
    16
        85 years and over
    0
    0
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    58.24 (39.9 to 84.1)
    57.36 (37.3 to 80.5)
    58.23 (37.3 to 82.2)
    59.15 (34.7 to 84.9)
    Gender Categorical
    Units: Subjects
        Female
    45
    47
    57
    56
    111
    108
        Male
    0
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Trastuzumab SC then IV
    Reporting group description
    		 Subjects received treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Subjects continued receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise subjects continued IV treatment) for a total of 18 cycles of treatment during the study.

    Reporting group title
    Trastuzumab IV then SC
    Reporting group description
    		 Subjects received treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Subjects continued receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise subjects continued IV treatment) for a total of 18 cycles of treatment during the study.

    Subject analysis set title
    Trastuzumab SC Then Trastuzumab IV mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified Intent-to-Treat (m-ITT) population: all subjects from the ITT population who received both routes (SC and IV) during the cross-over period and who completed the last question of the PPQ after the cross-over period

    Subject analysis set title
    Trastuzumab IV Then Trastuzumab SC mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified Intent-to-Treat (m-ITT) population: all subjects from the ITT population who received both routes (SC and IV) during the cross-over period and who completed the last question of the PPQ after the cross-over period

    Subject analysis set title
    Trastuzumab SC Then Trastuzumab IV ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of T SC or T IV during the cross-over period

    Subject analysis set title
    Trastuzumab IV Then Trastuzumab SC ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of T SC or T IV during the cross-over period

    Subject analysis set title
    Trastuzumab SC
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of Trastuzumab SC during the cross-over period.

    Subject analysis set title
    Trastuzumab IV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of Trastuzumab IV during the cross-over period.

    Primary: Percentage of Subjects With Preference for Either IV or SC Route of Administration According to Subjects Preference Questionnaire (PPQ) Score

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    End point title
    		 Percentage of Subjects With Preference for Either IV or SC Route of Administration According to Subjects Preference Questionnaire (PPQ) Score [1]
    End point description
    The analysis of the primary preference endpoint is presented in the m-ITT population (and in the PP population for the sensitivity primary analysis).
    End point type
    Primary
    End point timeframe
    Baseline up to 6 cycles (cycle length = 21 days)
    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 provided.
    End point values
    		 Trastuzumab SC Then Trastuzumab IV mITT Trastuzumab IV Then Trastuzumab SC mITT
    Number of subjects analysed
    47
    45
    Units: Percentage
    number (not applicable)
        Subjects preference to intravenous injection
    12.8
    15.6
        Subjects preference to subcutaneous injection
    87.2
    84.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Adverse Events

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    End point title
    		 Percentage of Subjects With Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    Approximately 6 years
    End point values
    		 Trastuzumab SC Trastuzumab IV
    Number of subjects analysed
    108
    111
    Units: Number
        number (not applicable)
    91.7
    43.2
    No statistical analyses for this end point

    Secondary: Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score

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    End point title
    		 Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score
    End point description
    Intent to treat: all randomized subjects who received at least one dose of T SC or T IV during the cross-over period
    End point type
    Secondary
    End point timeframe
    Baseline up to 6 cycles (cycle length = 21 days)
    End point values
    		 Trastuzumab SC Then Trastuzumab IV ITT Trastuzumab IV Then Trastuzumab SC ITT
    Number of subjects analysed
    52
    47
    Units: Percentage
    number (not applicable)
        IV
    13.5
    10.6
        No preference
    21.2
    27.7
        SC
    65.4
    61.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 6 years
    Adverse event reporting additional description
    Safety (SAF) population: all enrolled subjects who received at least one dose of study medication (T SC or T IV)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Trastuzumab SC
    Reporting group description
    		 All randomized subjects who received at least one dose of Trastuzumab SC during the cross-over period.

    Reporting group title
    Long-term follow-up period
    Reporting group description
    		 After the 1-year T treatment period, subjects were switched to standard treatment, according to Investigator’s choice and continued to be followed as recommended in routine clinical practice (every 6 months to assess vital status, disease progression and cardiac function) for additional 3 years.

    Reporting group title
    Trastuzumab IV
    Reporting group description
    		 All randomized subjects who received at least one dose of Trastuzumab IV during the cross-over period.

    Serious adverse events
    		 Trastuzumab SC Long-term follow-up period Trastuzumab IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 108 (12.04%)
    4 / 113 (3.54%)
    3 / 111 (2.70%)
         number of deaths (all causes)
    1
    1
    0
         number of deaths resulting from adverse events
    1
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    LEUKAEMIA
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANKLE FRACTURE
         subjects affected / exposed
    4 / 108 (3.70%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROCEDURAL PAIN
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    WRONG PRODUCT ADMINISTERED
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ANAL FISSURE
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 113 (0.88%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CONSTIPATION
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    METRORRHAGIA
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    LUNG DISORDER
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY DISTRESS
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHOLESTASIS
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ERYSIPELAS
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    DEVICE DISLOCATION
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Trastuzumab SC Long-term follow-up period Trastuzumab IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    99 / 108 (91.67%)
    17 / 113 (15.04%)
    44 / 111 (39.64%)
    Investigations
    WEIGHT INCREASED
         subjects affected / exposed
    11 / 108 (10.19%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    11
    0
    0
    EJECTION FRACTION DECREASED
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 113 (1.77%)
    1 / 111 (0.90%)
         occurrences all number
    4
    3
    1
    WEIGHT DECREASED
         subjects affected / exposed
    9 / 108 (8.33%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    9
    0
    1
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    6 / 108 (5.56%)
    2 / 113 (1.77%)
    3 / 111 (2.70%)
         occurrences all number
    10
    3
    5
    HAEMATOMA
         subjects affected / exposed
    6 / 108 (5.56%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    8
    0
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    14 / 108 (12.96%)
    3 / 113 (2.65%)
    2 / 111 (1.80%)
         occurrences all number
    30
    3
    4
    PARAESTHESIA
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 113 (0.88%)
    2 / 111 (1.80%)
         occurrences all number
    6
    1
    2
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    31 / 108 (28.70%)
    2 / 113 (1.77%)
    4 / 111 (3.60%)
         occurrences all number
    36
    2
    4
    INJECTION SITE PAIN
         subjects affected / exposed
    30 / 108 (27.78%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    53
    0
    1
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    17 / 108 (15.74%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    46
    0
    0
    FATIGUE
         subjects affected / exposed
    5 / 108 (4.63%)
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    7
    0
    2
    PYREXIA
         subjects affected / exposed
    4 / 108 (3.70%)
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    4
    0
    5
    INJECTION SITE HAEMATOMA
         subjects affected / exposed
    5 / 108 (4.63%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    5
    0
    1
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    7 / 108 (6.48%)
    1 / 113 (0.88%)
    2 / 111 (1.80%)
         occurrences all number
    7
    1
    2
    NAUSEA
         subjects affected / exposed
    7 / 108 (6.48%)
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    7
    0
    2
    VOMITING
         subjects affected / exposed
    5 / 108 (4.63%)
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    5
    0
    4
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    7 / 108 (6.48%)
    1 / 113 (0.88%)
    1 / 111 (0.90%)
         occurrences all number
    8
    1
    1
    COUGH
         subjects affected / exposed
    4 / 108 (3.70%)
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    4
    0
    2
    Skin and subcutaneous tissue disorders
    ERYTHEMA
         subjects affected / exposed
    6 / 108 (5.56%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    7
    0
    0
    PRURITUS
         subjects affected / exposed
    6 / 108 (5.56%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    7
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    16 / 108 (14.81%)
    0 / 113 (0.00%)
    4 / 111 (3.60%)
         occurrences all number
    17
    0
    5
    MUSCLE SPASMS
         subjects affected / exposed
    10 / 108 (9.26%)
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    11
    0
    2
    BACK PAIN
         subjects affected / exposed
    6 / 108 (5.56%)
    1 / 113 (0.88%)
    3 / 111 (2.70%)
         occurrences all number
    6
    1
    3
    PAIN IN EXTREMITY
         subjects affected / exposed
    6 / 108 (5.56%)
    0 / 113 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    7
    0
    0
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    13 / 108 (12.04%)
    0 / 113 (0.00%)
    3 / 111 (2.70%)
         occurrences all number
    15
    0
    3
    RHINITIS
         subjects affected / exposed
    6 / 108 (5.56%)
    1 / 113 (0.88%)
    2 / 111 (1.80%)
         occurrences all number
    6
    1
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    5 / 108 (4.63%)
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    5
    0
    2
    URINARY TRACT INFECTION
         subjects affected / exposed
    4 / 108 (3.70%)
    3 / 113 (2.65%)
    0 / 111 (0.00%)
         occurrences all number
    4
    4
    0
    INFLUENZA
         subjects affected / exposed
    6 / 108 (5.56%)
    1 / 113 (0.88%)
    1 / 111 (0.90%)
         occurrences all number
    6
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2013
    In order to match to clinical practice, the screening period was enlarged (between Day -21 to Day 1 instead of Day -14 to Day 1) In order to match to clinical practice, the 9th inclusion criterion (mBC) was simplified Due to the modification of the Herceptin SC SPC, the 11th inclusion criterion was changed, as well as the modalities of treatment use
    21 Jun 2013
    Times windows were added for the visits during the treatment period and the safety follow-up visit (±2 days) and for the long-term follow-up visits (±7 days) In order to match to clinical practice, the 9th inclusion criterion (mBC) was simplified
    30 Jan 2014
    In order to match to clinical practice, cardiac safety assessments were required every 6 cycles (instead of 3)
    20 Apr 2015
    Due to the extension of the inclusion period (from 1 to 2 years), the total study duration covered 6 years instead of 5 years. After the 1-year T treatment period, patients were followed up to 3 additional years even in the event of disease progression in the meantime, to allow overall survival estimation.

    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/28648618
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