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    Clinical Trial Results:
    MESI-STRAT WOO 2 Trial / MESI-STRAT Prospective Window of opportunity trial of 3 weeks neoadjuvant Anastrozole in Postmenopausal Women with Estrogen receptor positive (ER+) Breast Cancer: WOO 2

    Summary
    EudraCT number
    		 2020-003960-22
    Trial protocol
    		 AT  
    Global end of trial date
    09 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jun 2024
    First version publication date
    22 Jun 2024
    Other versions
    Summary report(s)
    		 Justification letter non-reported endpoints

    Trial information

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    Trial identification
    Sponsor protocol code
    WOO2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Innsbruck
    Sponsor organisation address
    Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Regina Berger, Medizinische Universität Innsbruck Univ.-Klinik f. Gynäkologie und Geburtshilfe, regina.berger@i-med.ac.at
    Scientific contact
    Daniel Egle, Medizinische Universität Innsbruck Univ.-Klinik f. Gynäkologie und Geburtshilfe, Daniel.Egle@tirol-kliniken.at
    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
    29 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of kynurenine concentration before and after 21 days treatment with Anastrozole
    Protection of trial subjects
    The trial medication Anastrozole is a standard of care therapy for postmenopausal women. For ethical reasons only women that would receive an aromatase inhibitor after surgery will be included in the WOO 2 trial. Therefore only the sequence of aromatase inhibitor application will be altered as Anastrozole will be given for 3 weeks before routine surgery as opposed to its regular adjuvant application. Anastrozole is well known and approved by Austrian regulatory authorities for the treatment of postmenopausal ER+ BC patients. Due to its safety profile we expect only few serious adverse events (SAEs) to occur. All relevant safety information can be found in the Summary of Product Characteristics (SmPC). The IMU is experienced in neoadjuvant administration of Anastrozole.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2020
    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
    Austria: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    18
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 50 patients, who have received treatment, are required for analysis. Screening failure but not the drop-out rate is expected to be high, recruitment will commence once a total of 50 patients have started treatment.

    Pre-assignment
    Screening details
    		 During the screening phase the eligibility of the patient is assessed. The screening visit includes verification of all inclusion and exclusion criteria. Written informed consent is obtained. No trial specific interventions were made prior to written consent of the patient.

    Pre-assignment period milestones
    Number of subjects started
    		 56
    Number of subjects completed
    		 56

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

    Arms
    Arm title
    		 All participants
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ARIMIDEX 1mg
    Investigational medicinal product code
    Other name
    Anastrozole
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg per day orally

    Number of subjects in period 1
    		All participants
    Started
    56
    Completed
    52
    Not completed
    4
         Consent withdrawn by subject
    3
         No surgery possible due to atrial fibrillation.
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Reporting group values
    		 All participants Total
    Number of subjects
    		 56 56
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 38 38
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.1 ± 8.4 -
    Gender categorical
    Units: Subjects
        Female
    		 56 56

    End points

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    End points reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Primary: kynurenine level (KYN)

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    End point title
    		 kynurenine level (KYN) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Before treatment start and directly after 21 days of neoadjuvant Anastrozole therapy.
    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: Single arm study.
    End point values
    		 All participants
    Number of subjects analysed
    51
    Units: µM
        arithmetic mean (standard deviation)
    1.57 ± 0.48
    No statistical analyses for this end point

    Secondary: change in Ki67 expression

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    End point title
    		 change in Ki67 expression
    End point description
    End point type
    Secondary
    End point timeframe
    21 days
    End point values
    		 All participants
    Number of subjects analysed
    51
    Units: percent
        arithmetic mean (standard deviation)
    8.65 ± 5.30
    No statistical analyses for this end point

    Secondary: MESI network

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    End point title
    		 MESI network
    End point description
    End point type
    Secondary
    End point timeframe
    21 days
    End point values
    		 All participants
    Number of subjects analysed
    51
    Units: micromole(s)
        median (confidence interval 95%)
    6.1 (3.94 to 8.46)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Investigators collected adverse events (AEs) during measurements on all study days. The observation period started with the first IMP administration (preceded by medical history) and ended at the last study visit, about four weeks after the final dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 56 (1.79%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Infection-triggered cardiac decompensation
         subjects affected / exposed
    1 / 56 (1.79%)
         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 participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 56 (39.29%)
    Vascular disorders
    Hot flashes
         subjects affected / exposed
    8 / 56 (14.29%)
         occurrences all number
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2023
    Change in timeline.

    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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