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    Clinical Trial Results:
    Molecular profiling of postmenopausal women with breast cancer on neoadjuvant exemestane or tamoxifen. MONET version 1

    Summary
    EudraCT number
    		 2005-001698-89
    Trial protocol
    		 GB  
    Global end of trial date
    05 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Monet
    Additional study identifiers
    ISRCTN number
    		 ISRCTN87408408
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge University Hospitals NHS Foundation Trus, United Kingdom, CB2 0QQ
    Public contact
    Anne-Laure Vallier, Cambridge University Hospitals NHS Foundation Trust, +44 1223 348086, anne-laure.vallier@addenbrookes.nhs.uk
    Scientific contact
    Dr. Helena Earl, University of Cambridge , +44 1223 335800, hme22@cam.ac.uk
    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
    Interim
    Date of interim/final analysis
    05 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To perform prospective analysis of (i) gene expression profiles; (ii) previously identified candidate genes; and (iii) blood analysis, before, during, and after neoadjuvant therapy with exemestane or tamoxifen to identify genes, gene profiles and serum markers predictive of response and resistance. PLEASE NOTE: No analysis was done for this study, hence we cannot provide interim/final analysis date. The "Date of interim/final analysis" field was checked in error, but there is no way to un-check it. Besides the field is also mandatory and is preventing us from posting the study. To enable us post the study result data we have therefore set the "Date of interim/final analysis" to the "Global end of trial date, i.e., 05-June-2015.
    Protection of trial subjects
    “Protocol design: various exclusion criteria, screening, and on-treatment investigations conducted to ascertain and maintain knowledge of patients' fitness to receive the trial treatment; on-study toxicity management guidelines; and continuous monitoring and dissemination of the safety data for the treatments used throughout the trial, and of the patients themselves.”
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Apr 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    23
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 “Patients were approached, consented, and recruited at hospital oncology clinics for recently-diagnosed, ER positive, early (non-metastatic) breast cancer. Recruitment period was from Apr 2007 – Mar 2010.”

    Pre-assignment
    Screening details
    		 “Women with diagnosis of primary invasive breast cancer on core biopsy; not suitable for chemotherapy; Localised or locally advanced disease: tumour size >10mm on US or T4 tumour of any size with direct extension to chest wall or skin, Inflammatory carcinoma with tumour of any size, Other Locally Advanced disease, Clinical & radiological involvemen

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control Arm
    Arm description
    		 Tamoxifen
    Arm type
    		 Control arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Research Arm
    Arm description
    		 Exemestane
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exemestane
    Investigational medicinal product code
    Exemestane
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25mg daily for 16 weeks

    Investigational medicinal product name
    Tamoxifen
    Investigational medicinal product code
    Tamoxifen
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg daily for 16 weeks

    Number of subjects in period 1
    		Control Arm Research Arm
    Started
    13
    13
    Completed
    9
    10
    Not completed
    4
    3
         Physician decision
    2
    1
         Consent withdrawn by subject
    -
    1
         Disease progression
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control Arm
    Reporting group description
    		 Tamoxifen

    Reporting group title
    Research Arm
    Reporting group description
    		 Exemestane

    Reporting group values
    		 Control Arm Research Arm Total
    Number of subjects
    		 13 13 26
    Age categorical
    Tamoxifen
    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)
    		 1 0 1
        From 65-84 years
    		 12 12 24
        85 years and over
    		 0 1 1
    Gender categorical
    Units: Subjects
        Female
    		 13 13 26
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Control Arm
    Reporting group description
    		 Tamoxifen

    Reporting group title
    Research Arm
    Reporting group description
    		 Exemestane

    Primary: Response

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    End point title
    		 Response [1]
    End point description
    End point type
    Primary
    End point timeframe
    No data was collected as the study stopped early.
    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 data was collected as the study stopped early. No analysis was performed
    End point values
    		 Control Arm Research Arm
    Number of subjects analysed
    13 [2]
    13 [3]
    Units: People
    0
    0
    Notes
    [2] - No data was collected as the study stopped early
    [3] - No data was collected as the study stopped early
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From day of randomisation of first patient to end of treatment of final patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients randomised into the trial

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 26 (7.69%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Obstruction GI: Gallbladder (10017636)
    Additional description: Investigation for Gall Stones Note: CTCAE v3.0 (medDRA 10.0) were used in coding
    alternative dictionary used: MedDRA 10
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Other: dislocation: hip (10048592)
    Additional description: Dislocation of right hip joint Note: CTCAE v3.0 (medDRA 10.0) were used for coding
    alternative dictionary used: MedDRA 10
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 26 (88.46%)
    Nervous system disorders
    Pain: headache [10019211]
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    2
    restlessness [10015832]
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences all number
    2
    General disorders and administration site conditions
    fatigue [10016256]
         subjects affected / exposed
    12 / 26 (46.15%)
         occurrences all number
    27
    muscle / joint pain [10028411]
         subjects affected / exposed
    11 / 26 (42.31%)
         occurrences all number
    25
    Eye disorders
    haemorrhage/bleeding (eye) [10019524]
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Gastrointestinal disorders
    nausea [10028813]
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences all number
    3
    constipation [10010774]
         subjects affected / exposed
    4 / 26 (15.38%)
         occurrences all number
    6
    diarrhoea [10012727]
         subjects affected / exposed
    4 / 26 (15.38%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    cough [10011224]
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences all number
    5
    dyspnoea [10013963]
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    rash [10037853]
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    2
    Endocrine disorders
    hot flushes [10020407]
    Additional description: CTCAE v3.0 (medDRA 10.0)
         subjects affected / exposed
    14 / 26 (53.85%)
         occurrences all number
    33
    Infections and infestations
    infection: UTI [10046571]
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2006
    Clarification of eligibility and Protocol update. Correction of oversight in Patient Information Sheet.
    26 Jan 2007
    Introduction of standard practice treatment post surgery. Updates to the Protocol, Patient Information Sheet, and GP letter.

    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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