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    Clinical Trial Results:
    A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients.

    Summary
    EudraCT number
    		 2009-015122-11
    Trial protocol
    		 DE  
    Global end of trial date
    12 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 MALE synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    GBG54
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01638247
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GBG Forschungs GmbH
    Sponsor organisation address
    Martin-Behaim-Str. 12, Neu-Isenburg, Germany, 63263
    Public contact
    Medicine and Research, GBG Forschungs GmbH, +49 610274800, publications@gbg.de
    Scientific contact
    Medicine and Research, GBG Forschungs GmbH,, +49 610274800, publications@gbg.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
    19 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of estradiol suppression between the three treatment arms after three months by a standardized procedure for routine testing
    Protection of trial subjects
    The trial protocol including amendments, the patient information and the informed consent were reviewed and approved from a properly constituted IRB/IEC for each site prior to the study start. The trial was in compliance with the International Conference on Harmonization (ICH) - Harmonized Tripartite Guideline for Good Clinical Practice (GCP) (E6), and the Commission Directives in the European Community as well as with the applicable German national laws and regulations, and with Declaration of Helsinki and its revisions in all aspects of preparation, monitoring, reporting, auditing, and archiving. IDMC was to ensure the ethical conduct of the trial and to protect patients' safety interests in this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    31
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 55 months (Q-IV 2012 –Q-V 2017). 56 patients were randomized and 52 patients (17 in Tamoxifen arm, 17 in Tamoxifen + GnRH arm and 18 in Exemestane + GnRH arm) started therapy.

    Pre-assignment
    Screening details
    		 Male patients of at least 18 years of age with unilateral or bilateral breast cancer at primary diagnosis with estrogen receptor and/or progesterone receptor positive tumor. Enrollment in the neoadjuvant, adjuvant (with adequate surgical treatment with histological complete resection including axillary lymph nodes) and metastatic setting possible.

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Number of subjects completed
    		 52

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tamoxifen
    Arm description
    		 Tamoxifen 20 mg (standard therapy).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Exemestane (AROMASIN®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg per os each day one tablet

    Arm title
    		 Tamoxifen + GnRH
    Arm description
    		 Tamoxifen 20 mg + gonadotropin releasing hormone analogue (GnRH).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tamoxifen plus goserelin (ZOLADEX®) or leuprorelin (TRENANTONE®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tamoxifen 20mg, per os, each day one tablet, GnRH: goserelin (ZOLADEX®) or leuprorelin (TRENANTONE®) used according to investigators choice, according to the manufacturer´s summary of product characteristics, once every three months (twice within the study) for six months or until progression, patient’s request or withdrawal from the study (whatever comes first).

    Arm title
    		 Exemestane + GnRH
    Arm description
    		 Exemestane 25mg + gonadotropin releasing hormone analogue (GnRH).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exemestane (AROMASIN®) plus GnRH
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Exemestane (AROMASIN®), 25 mg, per os, each day one tablet GnRH: goserelin (ZOLADEX®) or leuprorelin (TRENANTONE®) used according to investigators choice, according to the manufacturer´s summary of product characteristics, once every three months (twice within the study) for six months or until progression, patient’s request or withdrawal from the study (whatever comes first).

    Number of subjects in period 1
    		Tamoxifen Tamoxifen + GnRH Exemestane + GnRH
    Started
    17
    17
    18
    Completed
    16
    16
    17
    Not completed
    1
    1
    1
         Patient`s wish
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         Progression
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tamoxifen
    Reporting group description
    		 Tamoxifen 20 mg (standard therapy).

    Reporting group title
    Tamoxifen + GnRH
    Reporting group description
    		 Tamoxifen 20 mg + gonadotropin releasing hormone analogue (GnRH).

    Reporting group title
    Exemestane + GnRH
    Reporting group description
    		 Exemestane 25mg + gonadotropin releasing hormone analogue (GnRH).

    Reporting group values
    		 Tamoxifen Tamoxifen + GnRH Exemestane + GnRH Total
    Number of subjects
    		 17 17 18 52
    Age categorical
    Units: Subjects
    Age continuous
    patients evaluable at 3 months
    Units: years
        median (full range (min-max))
    		 59 (37 to 83) 60 (45 to 82) 66 (45 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 17 17 18 52
    Subject analysis sets

    Subject analysis set title
    Tamoxifen
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all evaluable patients at 3 months

    Subject analysis set title
    Tamoxifen + GnRH
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all evaluable patients at 3 months

    Subject analysis set title
    Exemestane + GnRH
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all evaluable patients at 3 months

    Subject analysis sets values
    		 Tamoxifen Tamoxifen + GnRH Exemestane + GnRH
    Number of subjects
    17
    15
    18
    Age categorical
    Units: Subjects
    Age continuous
    patients evaluable at 3 months
    Units: years
        median (full range (min-max))
    59.0 (37.0 to 83.0)
    60.0 (45.0 to 82.0)
    66.0 (45.0 to 80.0)
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
        Male
    17
    15
    18

    End points

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    End points reporting groups
    Reporting group title
    Tamoxifen
    Reporting group description
    		 Tamoxifen 20 mg (standard therapy).

    Reporting group title
    Tamoxifen + GnRH
    Reporting group description
    		 Tamoxifen 20 mg + gonadotropin releasing hormone analogue (GnRH).

    Reporting group title
    Exemestane + GnRH
    Reporting group description
    		 Exemestane 25mg + gonadotropin releasing hormone analogue (GnRH).

    Subject analysis set title
    Tamoxifen
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all evaluable patients at 3 months

    Subject analysis set title
    Tamoxifen + GnRH
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all evaluable patients at 3 months

    Subject analysis set title
    Exemestane + GnRH
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all evaluable patients at 3 months

    Primary: changes in estradiol levels from baseline to 3 months

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    End point title
    		 changes in estradiol levels from baseline to 3 months
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to 3 months
    End point values
    		 Tamoxifen Tamoxifen + GnRH Exemestane + GnRH
    Number of subjects analysed
    17 [1]
    15 [2]
    18 [3]
    Units: ng/L
        median (full range (min-max))
    17 (-6 to 29)
    -23 (-40 to 22)
    -18.5 (-100 to 21)
    Notes
    [1] - patients evaluable at 3 months
    [2] - patients evaluable at 3 months
    [3] - patients evaluable at 3 months
    Statistical analysis title
    		 Change in estradiol level BL to 3 months 3 arms
    Comparison groups
    Tamoxifen v Tamoxifen + GnRH v Exemestane + GnRH
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [4] - Primarily, the Kruskal-Wallis test (due to the failed test of normality) was used to compare the decrease of estradiol level after three months study treatment between the three study arms.
    Statistical analysis title
    		 Change in estradiol level BL to 3 months B vs A
    Statistical analysis description
    Pairwise Wilcoxon tests arm B vs A
    Comparison groups
    Tamoxifen + GnRH v Tamoxifen
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Change in estradiol level BL to 3 months C vs A
    Comparison groups
    Tamoxifen v Exemestane + GnRH
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Change in estradiol level BL to 3 months C vs B
    Statistical analysis description
    comparison of Arm C vs B was unplanned
    Comparison groups
    Tamoxifen + GnRH v Exemestane + GnRH
    Number of subjects included in analysis
    33
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.587
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events occurring during the study treatment period were reported.
    Adverse event reporting additional description
    Non-serious AEs are reported per patient; any grade (1-4) during the complete treatment duration for the overall safety Population are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Tamoxifen
    Reporting group description
    		 Tamoxifen

    Reporting group title
    Tamoxifen + GnRH
    Reporting group description
    		 Tamoxifen + GnRH

    Reporting group title
    Exemestane + GnRH
    Reporting group description
    		 Exemestane + GnRH

    Serious adverse events
    		 Tamoxifen Tamoxifen + GnRH Exemestane + GnRH
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal ischaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Groin abscess
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tamoxifen Tamoxifen + GnRH Exemestane + GnRH
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 18 (88.89%)
    16 / 16 (100.00%)
    16 / 18 (88.89%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 18 (11.11%)
    10 / 16 (62.50%)
    12 / 18 (66.67%)
         occurrences all number
    2
    10
    12
    Vascular disorders
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 18 (27.78%)
    5 / 16 (31.25%)
    10 / 18 (55.56%)
         occurrences all number
    5
    5
    10
    Irritability
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    General disorders and administrative site conditions
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 18 (5.56%)
    8 / 16 (50.00%)
    7 / 18 (38.89%)
         occurrences all number
    1
    8
    7
    Reproductive system disorders
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    3 / 18 (16.67%)
    9 / 16 (56.25%)
    10 / 18 (55.56%)
         occurrences all number
    3
    9
    10
    Sleep disorder
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
    3 / 18 (16.67%)
         occurrences all number
    0
    1
    3
    Mental disorder
    Additional description: Other psychiatric disorders, any grade
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
    2 / 18 (11.11%)
         occurrences all number
    1
    1
    2
    Investigations
    Total cholesterol increased
         subjects affected / exposed
    3 / 18 (16.67%)
    3 / 16 (18.75%)
    9 / 18 (50.00%)
         occurrences all number
    3
    3
    9
    High density lipoprotein abnormal
    Additional description: HDL cholesterol abnormal (decreased), any grade
         subjects affected / exposed
    9 / 18 (50.00%)
    7 / 16 (43.75%)
    5 / 18 (27.78%)
         occurrences all number
    9
    7
    5
    Low density lipoprotein abnormal
    Additional description: LDL cholesterol abnormal (increased), any grade
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 16 (6.25%)
    4 / 18 (22.22%)
         occurrences all number
    2
    1
    4
    Prostatic specific antigen abnormal
    Additional description: PSA abnormal (increased), any grade
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    1
    Injury, poisoning and procedural complications
    Injury and poisoning, procedural complications
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 16 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    0
    3
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    1
    Other neurological disorders
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eye disorder
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    1
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    1
    Hepatobiliary disorders
    Hepatobilary disorders
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 16 (25.00%)
    2 / 18 (11.11%)
         occurrences all number
    3
    4
    2
    Bone pain
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 16 (25.00%)
    5 / 18 (27.78%)
         occurrences all number
    3
    4
    5
    Arthralgia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    2
    0
    2
    Musculoskeletal disorder
    Additional description: Other musculo-skeletal disorders, any grade
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Metabolic disorder
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2016
    There was one protocol amendment with the following main changes: Patients with DCIS will not be enrolled due to potential overtherapy. Extension of staging and lab value period before randomization. Adaption of PSA, ASAT, ALAT and bilirubin values.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33538790
    For support, Contact us.
    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
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