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    Clinical Trial Results:
    Evaluation of Response Rate to Pre-operative Docetaxel + Herceptin study part A and Docetaxel study part B In Locally Advanced Breast Cancer Patients, Stratified by HER2-Status, Trial Phase II

    Summary
    EudraCT number
    		 2005-000967-24
    Trial protocol
    		 DE  
    Global end of trial date
    07 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2021
    First version publication date
    09 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HED-324-PAE-0090-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00398489
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München, Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, München, Germany, 81675
    Public contact
    Dr. Stefan Paepke, Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde , +49 89 4140 2419, Stefan.Paepke@mri.tum.de
    Scientific contact
    Dr. Stefan Paepke, Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde , +49 89 4140 2419, Stefan.Paepke@mri.tum.de
    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
    06 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The evaluation of the efficacy of primary systemic therapy with: • Study part A: Herceptin® + docetaxel (HER2 positive) • Study part B: docetaxel monotherapy (HER2 negative). Comparison: rate of pathologic complete remission following neo adjuvant therapy arm A (HER2+): with docetaxel and Herceptin vs rate of pathologic complete remission following neo adjuvant therapy arm B (HER2-) with docetaxel and correlation with predictive factors Tolerability: Documentation of nature and frequency of adverse events (AEs/SAEs)
    Protection of trial subjects
    The conduct of this clinical study met the local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and the investigators connected to the study were GCP trained.
    Background therapy
    		 Medical treatment will be given according to the clinical trial centers’ Routine. Adjuvant Therapy: Part A: 4 x epirubicin 90 mg/m² + cyclophosphamide 600 mg/m² (q21) + Herceptin® 2 mg/kg weekly (visit 3–13), 6 mg/kg (visit 14–20), (visit 2 front loading) 4 mg/kg Part B: 4 x epirubicin 90 mg/m² + cyclophosphamide 600 mg/m² (q21) Endocrine therapy: ER/PR positive patients: pre-menopausal ≤ 40 years : Zoladex ® (2–3 years) + tamoxifen (5 years) > 40 years tamoxifen (5 years) postmenopausal anastrozol (5 years)
    Evidence for comparator
    		 n.a.
    Actual start date of recruitment
    06 Feb 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 94
    Worldwide total number of subjects
    94
    EEA total number of subjects
    94
    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)
    90
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Pre-screening processes were in place. The study was conducted multicentric in Germany between 06.02.2006 (first patient recruited) and 17.07.2008 (last patient included).

    Pre-assignment
    Screening details
    		 First, the screening procedure which includes e.g. examinations, imagings, hematology, biochemistry values such as core biopsy values and also predictive marker analysis, had to be completed. Patients must have all screening evaluations performed prior to the first dose of study drug and must meet all inclusion and none of the exclusion criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Study part A (HER2+)
    Arm description
    		 This study part contains HER2+ (overexpression) patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Taxotere
    Investigational medicinal product code
    L01CD02
    Other name
    Docetaxel
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Total: 600 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    ATC L01XC03
    Other name
    Herceptin, CAS number 180288-69-1
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Total: 106 mg/kg milligram(s)/kilogram

    Arm title
    		 Study part B (HER2-)
    Arm description
    		 This study part contains HER2- patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Taxotere
    Investigational medicinal product code
    L01CD02
    Other name
    Docetaxel
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Total: 600 mg/m2 milligram(s)/square meter

    Number of subjects in period 1
    		Study part A (HER2+) Study part B (HER2-)
    Started
    33
    61
    Completed
    29
    60
    Not completed
    4
    1
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    1
    -
         Lack of compliance
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 94 94
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 90 90
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 94 94
        Male
    		 0 0
    cT
    Tumor stage (clinical)
    Units: Subjects
        cT1
    		 2 2
        cT1c
    		 1 1
        cT2
    		 67 67
        cT3
    		 13 13
        cT4
    		 7 7
        cT4b
    		 1 1
        cT4d
    		 3 3
    cN
    Units: Subjects
        N0
    		 32 32
        N1
    		 48 48
        N2
    		 13 13
        N3
    		 1 1
    Subject analysis sets

    Subject analysis set title
    EAP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Efficacy Analysable Population includes all from the ITT except for patients with protocol deviations concerning inclusion and exclusion criteria and patients without surgery at the end of study treatment.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all patients who received at least one dose of study medication

    Subject analysis sets values
    		 EAP ITT
    Number of subjects
    89
    94
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    89
    94
        From 65-84 years
    0
    4
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    89
    94
        Male
    0
    0
    cT
    Tumor stage (clinical)
    Units: Subjects
        cT1
    2
        cT1c
    1
        cT2
    67
        cT3
    13
        cT4
    7
        cT4b
    1
        cT4d
    3
    cN
    Units: Subjects
        N0
    32
        N1
    48
        N2
    13
        N3
    1

    End points

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    End points reporting groups
    Reporting group title
    Study part A (HER2+)
    Reporting group description
    		 This study part contains HER2+ (overexpression) patients.

    Reporting group title
    Study part B (HER2-)
    Reporting group description
    		 This study part contains HER2- patients.

    Subject analysis set title
    EAP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Efficacy Analysable Population includes all from the ITT except for patients with protocol deviations concerning inclusion and exclusion criteria and patients without surgery at the end of study treatment.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all patients who received at least one dose of study medication

    Primary: pCR Tis

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    End point title
    		 pCR Tis
    End point description
    Pathological complete response pCR Tis is defined as the absence of infiltrating tumor cells from breast and lymph node (ypT0, Tis, ypN0). The incidence of pCR Tis in study group A was 44.8% with bootstrap 95%CI (27.6%, 62.1%). The incidence of pCR Tis in study group B was 23.3% with bootstrap 95%CI (13.3%, 35.0%).
    End point type
    Primary
    End point timeframe
    After surgery
    End point values
    		 Study part A (HER2+) Study part B (HER2-)
    Number of subjects analysed
    29 [1]
    60 [2]
    Units: Patients
        yes
    16
    14
        no
    13
    46
    Notes
    [1] - Analysis on the EAP set.
    [2] - Analysis on the EAP set.
    Statistical analysis title
    		 Difference in incidence of pCR Tis
    Statistical analysis description
    Difference in incidence rates of pCR Tis between study groups A and B.
    Comparison groups
    Study part B (HER2-) v Study part A (HER2+)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Chi-squared
    Confidence interval

    Primary: pCR lite

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    End point title
    		 pCR lite
    End point description
    Pathological complete response pCR Tis is defined as the absence of infiltrating tumor cells from breast and lymph node (ypT0, Tis, ypN0). The incidence of pCR lite in study group A was 55.2% with bootstrap 95%CI (37.9%, 72.4%). The incidence of pCR lite in study group B was 30.0% with bootstrap 95%CI (20.0%, 41.7%).
    End point type
    Primary
    End point timeframe
    After surgery
    End point values
    		 Study part A (HER2+) Study part B (HER2-)
    Number of subjects analysed
    29 [3]
    60 [4]
    Units: Patients
        yes
    16
    18
        no
    13
    42
    Notes
    [3] - Analyzed on EAP
    [4] - Analyzed on EAP
    Statistical analysis title
    		 Difference in incidence rates of pCR lite
    Statistical analysis description
    Difference in incidence rates of pCR lite between study groups A and B.
    Comparison groups
    Study part A (HER2+) v Study part B (HER2-)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Overall survial

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    End point title
    		 Overall survial
    End point description
    The mean 60 months survival was 86.6% with a 2-sided 95%CI of (81.5, 91.7).
    End point type
    Secondary
    End point timeframe
    60 months
    End point values
    		 EAP
    Number of subjects analysed
    88 [5]
    Units: Patients
        event
    17
        censored
    71
    Notes
    [5] - Only 88 patients delivered values for the Kaplan-Meier analysis
    No statistical analyses for this end point

    Secondary: Mastectomy rate

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    End point title
    		 Mastectomy rate
    End point description
    Rate of patients undergoing mastectomy vs. breast conserving therapy.
    End point type
    Secondary
    End point timeframe
    after surgery
    End point values
    		 EAP
    Number of subjects analysed
    89
    Units: Patients
        mastectomy
    30
        breast-conserving therapy
    59
    No statistical analyses for this end point

    Secondary: Concordance between cCR and pCR Tis

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    End point title
    		 Concordance between cCR and pCR Tis
    End point description
    Number of patients with concordant results from the clinical and pathological evaluation.
    End point type
    Secondary
    End point timeframe
    after surgery
    End point values
    		 EAP
    Number of subjects analysed
    68 [6]
    Units: Patients
        concordant
    36
        not concordant
    32
    Notes
    [6] - Clinical response was available for 68 patients.
    No statistical analyses for this end point

    Secondary: Concordance between sCR and pCR Tis

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    End point title
    		 Concordance between sCR and pCR Tis
    End point description
    Number of patients with concordant results from the sonographical and pathological evaluation.
    End point type
    Secondary
    End point timeframe
    after surgery
    End point values
    		 EAP
    Number of subjects analysed
    78 [7]
    Units: Patients
        concordant
    39
        not concordant
    39
    Notes
    [7] - Sonographic response was available for 78 patients.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients who received at least one dose of study medication.

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 94 (40.43%)
         number of deaths (all causes)
    10
         number of deaths resulting from adverse events
    10
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm malignant
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Mastectomy
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    10 / 94 (10.64%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 10
    Fatigue
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    12 / 94 (12.77%)
         occurrences causally related to treatment / all
    17 / 17
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Breast disorder
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural complication
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertonia
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    13 / 94 (13.83%)
         occurrences causally related to treatment / all
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal symptom
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast infection
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 94 (1.06%)
         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
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 94 (97.87%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    10 / 94 (10.64%)
         occurrences all number
    19
    Thrombosis
         subjects affected / exposed
    4 / 94 (4.26%)
         occurrences all number
    6
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    46 / 94 (48.94%)
         occurrences all number
    118
    Asthenia
         subjects affected / exposed
    62 / 94 (65.96%)
         occurrences all number
    289
    Pyrexia
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences all number
    5
    Mucosal inflammation
         subjects affected / exposed
    13 / 94 (13.83%)
         occurrences all number
    29
    Pain
         subjects affected / exposed
    12 / 94 (12.77%)
         occurrences all number
    16
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    30 / 94 (31.91%)
         occurrences all number
    59
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    45 / 94 (47.87%)
         occurrences all number
    126
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    5
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    65 / 94 (69.15%)
         occurrences all number
    114
    Hypertonia
         subjects affected / exposed
    10 / 94 (10.64%)
         occurrences all number
    21
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    8 / 94 (8.51%)
         occurrences all number
    9
    Anaemia
         subjects affected / exposed
    16 / 94 (17.02%)
         occurrences all number
    40
    Leukopenia
         subjects affected / exposed
    8 / 94 (8.51%)
         occurrences all number
    13
    Neutropenia
         subjects affected / exposed
    4 / 94 (4.26%)
         occurrences all number
    8
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    54 / 94 (57.45%)
         occurrences all number
    156
    Lacrimation increased
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    42 / 94 (44.68%)
         occurrences all number
    86
    Dysphagia
         subjects affected / exposed
    18 / 94 (19.15%)
         occurrences all number
    37
    Nausea
         subjects affected / exposed
    39 / 94 (41.49%)
         occurrences all number
    91
    Vomiting
         subjects affected / exposed
    13 / 94 (13.83%)
         occurrences all number
    19
    Stomatitis
         subjects affected / exposed
    54 / 94 (57.45%)
         occurrences all number
    158
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    86 / 94 (91.49%)
         occurrences all number
    431
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    29 / 94 (30.85%)
         occurrences all number
    62
    Nail disorder
         subjects affected / exposed
    56 / 94 (59.57%)
         occurrences all number
    126
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    52 / 94 (55.32%)
         occurrences all number
    181
    Myalgia
         subjects affected / exposed
    41 / 94 (43.62%)
         occurrences all number
    155
    Infections and infestations
    Infection
         subjects affected / exposed
    26 / 94 (27.66%)
         occurrences all number
    37
    Metabolism and nutrition disorders
    Fluid retention
         subjects affected / exposed
    33 / 94 (35.11%)
         occurrences all number
    76

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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