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    Clinical Trial Results:
    An open-label, single-arm, multicentre, Phase II study of oral lapatinib in combination with paclitaxel as first-line treatment for ErbB2-amplified metastatic breast cancer patients

    Summary
    EudraCT number
    2005-003945-16
    Trial protocol
    LV  
    Global end of trial date
    20 Nov 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    07 Feb 2016
    First version publication date
    26 Mar 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    statistical data missing from primary endpoint, update with data.

    Trial information

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    Trial identification
    Sponsor protocol code
    EGF105764
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    28 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate overall tumour response rate (ORR) of lapatinib combined with paclitaxel in patients with ErbB2-amplified metastatic breast cancer
    Protection of trial subjects
    Not Applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 May 2006
    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
    Latvia: 5
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Russian Federation: 33
    Country: Number of subjects enrolled
    Romania: 4
    Worldwide total number of subjects
    57
    EEA total number of subjects
    24
    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)
    50
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Study medication was dispensed to the subject on Day 1 after it was confirmed that the participants met all eligibility criteria and all screening assessments were completed.

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

    Arms
    Arm title
    Lapatinib with paclitaxel
    Arm description
    Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    Lapatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1500mg, orally, OD

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    80mg/m2 ,IV weekly for 3 weeks in a 4 week cycle

    Number of subjects in period 1
    Lapatinib with paclitaxel
    Started
    57
    Completed
    8
    Not completed
    49
         Death
    35
         Participant Could Not Make a Checkup
    1
         Site Closed during Follow-up
    2
         Study Is Terminating
    3
         Consent withdrawn by subject
    6
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lapatinib with paclitaxel
    Reporting group description
    Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

    Reporting group values
    Lapatinib with paclitaxel Total
    Number of subjects
    57 57
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.3 ± 9.3 -
    Gender categorical
    Units: Subjects
        Female
    57 57
        Male
    0 0
    Race
    Units: Subjects
        White - White/Caucasian/European Heritage
    57 57

    End points

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    End points reporting groups
    Reporting group title
    Lapatinib with paclitaxel
    Reporting group description
    Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

    Primary: Number of participants (par) with a best overall response (OR) of confirmed complete response (CR) or partial response (PR), as assessed by the Independent Review Committee (IRC)

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    End point title
    Number of participants (par) with a best overall response (OR) of confirmed complete response (CR) or partial response (PR), as assessed by the Independent Review Committee (IRC) [1]
    End point description
    OR is defined as the number of par achieving either a CR or PR. The best OR is the best response recorded from the start of treatment(trt) until progressive disease(PD)/recurrence. CR is the disappearance of all target lesions (TLs) and non-TLs. PR is at least a 30% decrease in the sum of the longest diameters(LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the trt started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Par with an unknown or missing response are treated as non-responders. The estimated value(EV) represents the % of par with a confirmed CR or PR. Confidence interval 95% (37.3, 64.4); EV 50.9.
    End point type
    Primary
    End point timeframe
    From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)
    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 system does not allow for statistical analysis for studies with a single treatment arm. Statistical comparison between category results are provided in the endpoint description.
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    57 [2]
    Units: Participants
        CR
    0
        PR
    29
    Notes
    [2] - Intent-to-Treat (ITT) Population: all participants who received study medication.
    No statistical analyses for this end point

    Secondary: Number of participants with a best overall response (OR) of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator

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    End point title
    Number of participants with a best overall response (OR) of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator
    End point description
    OR is defined as the number of participants achieving either a CR or PR, per RECIST. The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the Investigator. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.
    End point type
    Secondary
    End point timeframe
    From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    57 [3]
    Units: Participants
        CR
    3
        PR
    41
    Notes
    [3] - ITT Population
    No statistical analyses for this end point

    Secondary: Duration of response (DoR), as assessed by the IRC

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    End point title
    Duration of response (DoR), as assessed by the IRC
    End point description
    DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.
    End point type
    Secondary
    End point timeframe
    From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    29 [4]
    Units: Weeks
        median (confidence interval 95%)
    39.7 (26.9 to 50)
    Notes
    [4] - ITT Population. Only those participants with CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Duration of response (DoR), as assessed by the Investigator

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    End point title
    Duration of response (DoR), as assessed by the Investigator
    End point description
    DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.
    End point type
    Secondary
    End point timeframe
    From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    44 [5]
    Units: Weeks
        median (confidence interval 95%)
    42.3 (37.7 to 64.1)
    Notes
    [5] - ITT Population. Only those participants with CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Time to response, as assessed by the IRC

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    End point title
    Time to response, as assessed by the IRC
    End point description
    Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.
    End point type
    Secondary
    End point timeframe
    From randomization until the first documented evidence of a PR or CR (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    29 [6]
    Units: Weeks
        median (confidence interval 95%)
    8.4 (7.9 to 11.1)
    Notes
    [6] - ITT Population. Only those participants with CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Time to response, as assessed by the Investigator

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    End point title
    Time to response, as assessed by the Investigator
    End point description
    Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.
    End point type
    Secondary
    End point timeframe
    From randomization until the first documented evidence of a PR or CR (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    44 [7]
    Units: Weeks
        median (confidence interval 95%)
    8 (7.9 to 8.1)
    Notes
    [7] - ITT Population. Only those participants with CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Time to progression, as assessed by the IRC and the Investigator

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    End point title
    Time to progression, as assessed by the IRC and the Investigator
    End point description
    Time to progression is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to breast cancer, whichever occurs first. Participents who did not progress or die were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response. Please note that the IRC upper limit of the 95% confidence interval could not be determined (not reached) because there were not enough events to be able to calculate; therefore the value of 99999 was entered which represents NA.
    End point type
    Secondary
    End point timeframe
    From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    57 [8]
    Units: Weeks
    median (confidence interval 95%)
        IRC
    47.9 (40 to 99999)
        Investigator
    50.9 (47 to 64.3)
    Notes
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Progression-free survival, as assessed by the IRC and the Investigator

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    End point title
    Progression-free survival, as assessed by the IRC and the Investigator
    End point description
    Progression-free survival is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to any cause, whichever occurs first. Participants who did not progress in their disease were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response. Please note that the IRC upper limit of the 95% confidence interval could not be determined (not reached) because there were not enough events to be able to calculate; therefore, the value of 99999 was entered which represents NA.
    End point type
    Secondary
    End point timeframe
    From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    57 [9]
    Units: Weeks
    median (confidence interval 95%)
        IRC
    47.9 (40 to 99999)
        Investigator
    50.9 (47 to 64.3)
    Notes
    [9] - ITT Population
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    Overall survival is defined as the interval between the date of treatment start and the date of death due to any cause. For participants who did not die, follow-up was censored as the date of last contact. For participants who did not die, follow-up was censored at the date of last contact. At the time of this analysis, the median and the 95% confidence interval could not be determined because there were not enough deaths to calculate these estimates; therefore, the value of 99999 was entered which represents NA.
    End point type
    Secondary
    End point timeframe
    From the date of the first dose until the date of death due to any cause (up to Week 86)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    57 [10]
    Units: Weeks
        median (confidence interval 95%)
    99999 (99999 to 99999)
    Notes
    [10] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) or serious adverse event (SAE)

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    End point title
    Number of participants with any adverse event (AE) or serious adverse event (SAE)
    End point description
    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.
    End point type
    Secondary
    End point timeframe
    From the start of study medication until 28 days after the last dose (up to Study Week 381)
    End point values
    Lapatinib with paclitaxel
    Number of subjects analysed
    57 [11]
    Units: Participants
        Any AE
    57
        Any SAE
    11
    Notes
    [11] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 28 days after the last dose (up to Study Week 381).
    Adverse event reporting additional description
    SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Lapatinib plus paclitaxel
    Reporting group description
    Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

    Serious adverse events
    Lapatinib plus paclitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 57 (19.30%)
         number of deaths (all causes)
    35
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess soft tissue
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 57 (1.75%)
         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
    Lapatinib plus paclitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 57 (98.25%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 57 (17.54%)
         occurrences all number
    24
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    12
    Weight decreased
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    7
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    5
    Epistaxis
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    25 / 57 (43.86%)
         occurrences all number
    70
    Leukopenia
         subjects affected / exposed
    10 / 57 (17.54%)
         occurrences all number
    18
    Anaemia
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    21
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    14 / 57 (24.56%)
         occurrences all number
    15
    Neuropathy peripheral
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    9
    Headache
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    15 / 57 (26.32%)
         occurrences all number
    28
    Oedema peripheral
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    9
    Asthenia
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    32 / 57 (56.14%)
         occurrences all number
    143
    Abdominal pain upper
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    12
    Nausea
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    11
    Vomiting
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    6
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    23 / 57 (40.35%)
         occurrences all number
    39
    Alopecia
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    17
    Nail disorder
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    11
    Nail dystrophy
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    13
    Bone pain
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    17
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    6
    Erysipelas
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    5
    Paronychia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    7
    Respiratory tract infection
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2007
    Amendment 1/ to allow use of generic paclitaxel
    13 Jun 2008
    Amendment 2/ The protocol has been amended to include the information regarding hepatotoxicity associated with lapatinib treatment.
    14 Jul 2008
    Amendment 2/ As part of the liver toxicity update of GM2005/00370/02, inclusion of pharmacokinetics sample needing to be taken has been added to the follow up criteria in section 6.2.3.2.

    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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