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    Clinical Trial Results:
    A Phase II Trial Evaluating the Combined Use of Gemcitabine, Trastuzumab and Erlotinib as a First Line Chemotherapy Treatment in Patients with Metastatic Adenocarcinoma of the Pancreas

    Summary
    EudraCT number
    		 2009-016875-30
    Trial protocol
    		 FR  
    Global end of trial date
    19 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Feb 2023
    First version publication date
    23 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VA 2009/40
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01204372
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    INSTITUT DU CANCER DE MONTPELLIER (ICM)
    Sponsor organisation address
    208 RUE DES APOTHICAIRES, MONTPELLIER, France, 34298 CEDEX 5
    Public contact
    Aurore MOUSSION, INSTITUT DU CANCER DE MONTPELLIER, 33 0467613102, Drci-icm105@icm.unicancer.fr
    Scientific contact
    Aurore MOUSSION, INSTITUT DU CANCER DE MONTPELLIER, 33 0467613102, Drci-icm105@icm.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
    12 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the rate of disease control according to the criteria RECIST from the combined use of gemcitabine, trastuzumab and erlotinib.
    Protection of trial subjects
    In order to ensure the safety protection of trial subjects, G-CSF had been added
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    46
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 • Metastatic adenocarcinoma of the pancreas confirmed by histology available • Lesion able to be measured according to the criteria RECIST • Index of performance ≤ 1 according to OMS • Age of patient ≥ 18 y/old • Life expectancy of at least 3 months

    Period 1
    Period 1 title
    OVERALL TRIAL (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 SINGLE ARM
    Arm description
    		 GEMCITABINE + TRASTUZUMAB + ERLOTINIB
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEMCITABINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intraventricular use
    Dosage and administration details
    DOSAGE : 1000 mg/m2 For the first eight weeks of treatment the injections will be given at D1, D8, D15, D22, D29, D36 and D43 followed by one week of rest (one injection/week, 7 weeks/8). Subsequently, gemcitabine will be administered at D1, D8 and D15 of each 4 week cycle (one injection/week, 3 weeks/4).

    Investigational medicinal product name
    TRASTUZUMAB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intraventricular use
    Dosage and administration details
    DOSAGE : 4 mg/kg Every week :. It will be administered at a dose of 4 mg/kg over 90 minutes at D1 and then at 2 mg/kg over 30 minutes for the subsequent perfusions.

    Investigational medicinal product name
    ERLOTINIB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The erlotinib will be administered orally at a dose of 100mg/day from C1D1.

    Number of subjects in period 1
    		SINGLE ARM
    Started
    63
    Completed
    63

    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
    		 63 63
    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)
    		 46 46
        From 65-84 years
    		 17 17
        85 years and over
    		 0 0
        18-64
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (35 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 37 37
    Subject analysis sets

    Subject analysis set title
    PER PROTOCOL
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All included patients in the study and who received at least one treatment administration with no major violation of the inclusion or non-inclusion criteria.

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All included patients in the study who completed at least 2 cycles of treatment or discontinued for tumor progression

    Subject analysis sets values
    		 PER PROTOCOL Efficacy population
    Number of subjects
    62
    59
    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)
    45
    44
        From 65-84 years
    17
    15
        85 years and over
    0
    0
        18-64
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    62 (35 to 77)
    62 (35 to 77)
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    SINGLE ARM
    Reporting group description
    		 GEMCITABINE + TRASTUZUMAB + ERLOTINIB

    Subject analysis set title
    PER PROTOCOL
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All included patients in the study and who received at least one treatment administration with no major violation of the inclusion or non-inclusion criteria.

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All included patients in the study who completed at least 2 cycles of treatment or discontinued for tumor progression

    Primary: DISEASE CONTROL

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    End point title
    		 DISEASE CONTROL [1]
    End point description
    End point type
    Primary
    End point timeframe
    Every 8 weeks and at the treatment completion
    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: With a one-stage Fleming design, under the hypothese alpha = 5%, beta = 7.5%, p0 (the maximum inefficiency probability) = 40% and p1 (the minimum efficiency probability) = 60%, it is necessary to include 57 evaluable patients. If we consider only the first 57 evaluable patients, we observe a stabilization of the disease in 42/57 patients.According to the decision rule defined in the protocol, we therefore conclude that the trial is positive for the main endpoint.
    End point values
    		 SINGLE ARM Efficacy population
    Number of subjects analysed
    59
    59
    Units: PATIENT
        YES
    44
    44
        NO
    15
    15
    Attachments
    		 Untitled (Filename: 3-STAT_Rapport_GATE1_2014_07_17.pdf)
    No statistical analyses for this end point

    Secondary: PROGRESSION FREE SURVIVAL

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    End point title
    		 PROGRESSION FREE SURVIVAL
    End point description
    PROGRESSION FREE RATE AT 6 MONTHS
    End point type
    Secondary
    End point timeframe
    Every 8 weeks and at the treatment completion
    End point values
    		 PER PROTOCOL
    Number of subjects analysed
    62
    Units: percent
        number (confidence interval 95%)
    25.8 (15.7 to 37.1)
    No statistical analyses for this end point

    Secondary: OVERALL SURVIVAL

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    End point title
    		 OVERALL SURVIVAL
    End point description
    OVERALL SURVIVAL RATE AT 6 MONTHS
    End point type
    Secondary
    End point timeframe
    Every 8 weeks and at the treatment completion
    End point values
    		 PER PROTOCOL
    Number of subjects analysed
    62
    Units: percent
        number (confidence interval 95%)
    56.5 (43.2 to 67.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    EVERY 4 WEEKS
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    SAFETY POPULATION
    Reporting group description
    		 ALL INCLUDED PATIENTS AND WHO RECEIVED AT LEAST ONE DOSE OF TREATMENT

    Serious adverse events
    		 SAFETY POPULATION
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 62 (41.94%)
         number of deaths (all causes)
    27
         number of deaths resulting from adverse events
    12
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    7 / 62 (11.29%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    Vascular disorders
    Oedema
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    cardiogenic shoc
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    CARDIO RESPIRATORY ARREST
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Aortic thrombosis
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Abdominal Pain
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    10 / 62 (16.13%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 7
    Embolism
         subjects affected / exposed
    10 / 62 (16.13%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    Cerebrovascular accident
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    fever
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    diabetes
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    anorexia
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Death
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Vertigo
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MUCOSITIS
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    ACCIDENTAL STUDY DRUG OVERDOSING
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    7 / 62 (11.29%)
         occurrences causally related to treatment / all
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    OCCLUSION
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Nausea
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 1
    Ileus
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    small intestine occlusion
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    HEMATEMESIS
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Cholecystitis
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ascites
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Plexus alcoolisation
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Biliary tract infection
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    infectious pneumopathy
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SAFETY POPULATION
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 62 (100.00%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    General disorders and administration site conditions
    Dysgeusia
         subjects affected / exposed
    25 / 62 (40.32%)
         occurrences all number
    25
    Dyspepsia
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Dysphagia
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Weight decreased
         subjects affected / exposed
    32 / 62 (51.61%)
         occurrences all number
    32
    Oedema
         subjects affected / exposed
    25 / 62 (40.32%)
         occurrences all number
    25
    Asthenia
         subjects affected / exposed
    57 / 62 (91.94%)
         occurrences all number
    57
    fever
         subjects affected / exposed
    25 / 62 (40.32%)
         occurrences all number
    25
    General physical health deterioration
         subjects affected / exposed
    10 / 62 (16.13%)
         occurrences all number
    10
    Arthralgia
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    6
    Epistaxis
         subjects affected / exposed
    22 / 62 (35.48%)
         occurrences all number
    22
    Chills
         subjects affected / exposed
    13 / 62 (20.97%)
         occurrences all number
    13
    sweating
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    6
    Immune system disorders
    allergy
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Throat irritation
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Dysphonia
         subjects affected / exposed
    7 / 62 (11.29%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    18 / 62 (29.03%)
         occurrences all number
    18
    pneumopathy
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Rhinitis
         subjects affected / exposed
    16 / 62 (25.81%)
         occurrences all number
    16
    Cough
         subjects affected / exposed
    13 / 62 (20.97%)
         occurrences all number
    13
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    9 / 62 (14.52%)
         occurrences all number
    9
    Insomnia
         subjects affected / exposed
    16 / 62 (25.81%)
         occurrences all number
    16
    Depression
         subjects affected / exposed
    9 / 62 (14.52%)
         occurrences all number
    9
    Cardiac disorders
    Thrombosis
         subjects affected / exposed
    27 / 62 (43.55%)
         occurrences all number
    27
    Ejection fraction decreased
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Hypertension
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Nervous system disorders
    Neurological symptom
         subjects affected / exposed
    19 / 62 (30.65%)
         occurrences all number
    19
    Headache
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    6
    Tremor
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Vertigo
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    61 / 62 (98.39%)
         occurrences all number
    61
    Neutropenia
         subjects affected / exposed
    42 / 62 (67.74%)
         occurrences all number
    42
    thrombopenia
         subjects affected / exposed
    44 / 62 (70.97%)
         occurrences all number
    44
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    48 / 62 (77.42%)
         occurrences all number
    48
    Constipation
         subjects affected / exposed
    39 / 62 (62.90%)
         occurrences all number
    39
    Abdominal pain
         subjects affected / exposed
    57 / 62 (91.94%)
         occurrences all number
    57
    Nausea
         subjects affected / exposed
    45 / 62 (72.58%)
         occurrences all number
    45
    Vomiting
         subjects affected / exposed
    35 / 62 (56.45%)
         occurrences all number
    35
    Stomatitis
         subjects affected / exposed
    37 / 62 (59.68%)
         occurrences all number
    37
    bloating
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Abdominal distension
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Epigastric discomfort
         subjects affected / exposed
    13 / 62 (20.97%)
         occurrences all number
    13
    Flatulence
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    6
    Haemorrhoids
         subjects affected / exposed
    12 / 62 (19.35%)
         occurrences all number
    12
    Hiccups
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    meteorism
         subjects affected / exposed
    9 / 62 (14.52%)
         occurrences all number
    9
    buccal mycosis
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    occlusion
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    gastroesophageal reflux
         subjects affected / exposed
    21 / 62 (33.87%)
         occurrences all number
    21
    Dry mouth
         subjects affected / exposed
    11 / 62 (17.74%)
         occurrences all number
    11
    Ascites
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    7 / 62 (11.29%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    54 / 62 (87.10%)
         occurrences all number
    54
    Paronychia
         subjects affected / exposed
    8 / 62 (12.90%)
         occurrences all number
    8
    hand fissure
         subjects affected / exposed
    8 / 62 (12.90%)
         occurrences all number
    8
    Cheilitis
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Pruritus
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Dry skin
         subjects affected / exposed
    14 / 62 (22.58%)
         occurrences all number
    14
    Alopecia
         subjects affected / exposed
    11 / 62 (17.74%)
         occurrences all number
    11
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    muscle cramp
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    costal pain
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    13 / 62 (20.97%)
         occurrences all number
    13
    shoulder pain
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    lumbar pain
         subjects affected / exposed
    7 / 62 (11.29%)
         occurrences all number
    7
    legs pain
         subjects affected / exposed
    8 / 62 (12.90%)
         occurrences all number
    8
    arm pain
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    thoracic pain
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Infections and infestations
    Infection
         subjects affected / exposed
    27 / 62 (43.55%)
         occurrences all number
    27
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    10 / 62 (16.13%)
         occurrences all number
    10
    Anorexia and bulimia syndrome
         subjects affected / exposed
    55 / 62 (88.71%)
         occurrences all number
    55

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2011
    PROTOCOL MODIFICATION: toxicities management & MODIFICATION OF INVESTIGATOR LISTING
    28 Jan 2013
    PROTOCOL MODIFICATIONS : Pharmacovigilance process updated & MODIFICATIONS OF INVESTIGATORS LISTING
    27 May 2013
    PROTOCOL MODIFICATIONS : Modification of study period & MODIFICATIONS OF INVESTIGATORS LISTING
    18 Mar 2014
    PROTOCOL MODIFICATIONS : Trastuzumab BI updated & Modification of consent following Trastuzumab BI changes

    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.
    Adverse Events (AE) section: occurence of each AE was not available, we fullfilled with the number of patients.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33405269
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