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    Clinical Trial Results:
    A randomized phase III trial of Exemestane versus Anastrozole in postmenopausal women with receptor-positive primary breast cancer.

    Summary
    EudraCT number
    2005-001893-28
    Trial protocol
    HU   BE   IT  
    Global end of trial date
    31 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Feb 2020
    First version publication date
    07 Feb 2020
    Other versions
    Summary report(s)
    Publibation_Stearns_JCO_2015_DOI: 10.1200/JCO.2014.57.2461

    Trial information

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    Trial identification
    Sponsor protocol code
    IBCSG 30-04
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00066573
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    IBCSG
    Sponsor organisation address
    Effingerstrasse 40, Bern, Switzerland, 3008
    Public contact
    IBCSG Coordinating Center, IBCSG, +41 31 389 93 91, regulatoryoffice@ibcsg.org
    Scientific contact
    IBCSG Coordinating Center, IBCSG, +41 31 389 93 91, regulatoryoffice@ibcsg.org
    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
    15 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.
    Protection of trial subjects
    Permitted concomitant therapy: Osteoporosis: - Calcium intake - Biphosphonates for prevention or treatment of osteoporosis Therapies considered necessary for the subject's well-being which do not interfere with study endpoints: - Lipid lowering agents - NSAIDs and Cox-2 inhibitors (e.g. celecoxib, rofecoxib) - Herceptin prior to or concurrently with protocol therapy . Management of toxicity: - Hot Flashes Measures taken: Vitamin E; Low dose Clonidine; Venlafaxine; etc (no SERMs or hormones) - Vaginal Atrophy Measures taken: If refractory to local measures, may be treated with intermittent vaginal estrogens (maximum 3X/week) with lowest dose necessary to control symptoms. Use Estring only in patients who continue to have symptoms after 3X/week cream use. - Any other type of toxicities: Measures taken: A break from study medication of up to 4 weeks at one time is allowed to ascertain the source of patient’s intolerable symptoms. Similar breaks may be repeated until a total of 8 weeks off treatment have accumulated. Management of patients who need to stay off treatment for more than 4 weeks consecutively or more than 8 weeks in total will be at the discretion of the Investigator.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Jun 2003
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 114
    Country: Number of subjects enrolled
    Chile: 29
    Country: Number of subjects enrolled
    Peru: 3
    Country: Number of subjects enrolled
    Romania: 39
    Country: Number of subjects enrolled
    Switzerland: 92
    Country: Number of subjects enrolled
    South Africa: 44
    Country: Number of subjects enrolled
    Canada: 1301
    Country: Number of subjects enrolled
    United States: 5526
    Country: Number of subjects enrolled
    Belgium: 45
    Country: Number of subjects enrolled
    Hungary: 213
    Country: Number of subjects enrolled
    Italy: 170
    Worldwide total number of subjects
    7576
    EEA total number of subjects
    467
    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)
    4049
    From 65 to 84 years
    3449
    85 years and over
    78

    Subject disposition

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    Recruitment
    Recruitment details
    The first patient was randomized on 6 June 2003. The trial was closed for accrual on 31 July 2008 (IBCSG: 15 December 2006).

    Pre-assignment
    Screening details
    Not available.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Exemestane
    Arm description
    Patients receive oral exemestane (25 mg) once daily for 5 years.
    Arm type
    Experimental

    Investigational medicinal product name
    Exemestane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients receive oral exemestane (25 mg) once daily for 5 years. Treatment is be continued for five years unless unacceptable toxicity occurs or the subject has recurrent tumour or concurrent illness necessitates withdrawal or the patient decides to withdraw from participation for any reason.

    Arm title
    Anastrozole
    Arm description
    Patients receive oral anastrozole (1 mg) once daily for 5 years.
    Arm type
    Active comparator

    Investigational medicinal product name
    Anastrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients receive oral anastrozole (1 mg) once daily for 5 years. Treatment is continued for five years unless unacceptable toxicity occurs or the subject has recurrent tumour or concurrent illness necessitates withdrawal or the patient decides to withdraw from participation for any reason.

    Number of subjects in period 1
    Exemestane Anastrozole
    Started
    3789
    3787
    Completed
    3761
    3759
    Not completed
    28
    28
         Protocol deviation
    28
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Exemestane
    Reporting group description
    Patients receive oral exemestane (25 mg) once daily for 5 years.

    Reporting group title
    Anastrozole
    Reporting group description
    Patients receive oral anastrozole (1 mg) once daily for 5 years.

    Reporting group values
    Exemestane Anastrozole Total
    Number of subjects
    3789 3787 7576
    Age categorical
    Age as continuous characteristic only
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    63.9 (35.9 to 93.6) 64.3 (32.3 to 95.1) -
    Gender categorical
    Units: Subjects
        Female
    3789 3787 7576
        Male
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Exemestane
    Reporting group description
    Patients receive oral exemestane (25 mg) once daily for 5 years.

    Reporting group title
    Anastrozole
    Reporting group description
    Patients receive oral anastrozole (1 mg) once daily for 5 years.

    Primary: Event-free Survival

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    End point title
    Event-free Survival
    End point description
    Event-free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.
    End point type
    Primary
    End point timeframe
    5 years
    End point values
    Exemestane Anastrozole
    Number of subjects analysed
    3789
    3787
    Units: Percentage of participants
        number (confidence interval 95%)
    88 (87 to 89)
    89 (88 to 90)
    Statistical analysis title
    Statistical analysis EFS
    Statistical analysis description
    To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.
    Comparison groups
    Exemestane v Anastrozole
    Number of subjects included in analysis
    7576
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.85
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.87
         upper limit
    1.18

    Secondary: Overall Survival: Percentage of Participants Alive at 5 Years

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    End point title
    Overall Survival: Percentage of Participants Alive at 5 Years
    End point description
    Overall survival is defined as the time from randomization to the time of death from any cause.
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Exemestane Anastrozole
    Number of subjects analysed
    3789
    3787
    Units: Percentage of participants
        number (confidence interval 95%)
    92 (91 to 93)
    92 (91 to 93)
    Statistical analysis title
    Statistical analysis OS
    Comparison groups
    Exemestane v Anastrozole
    Number of subjects included in analysis
    7576
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.46
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    1.13
    Notes
    [1] - No power calculation for secondary analysis

    Secondary: Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence

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    End point title
    Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence
    End point description
    Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Exemestane Anastrozole
    Number of subjects analysed
    3789
    3787
    Units: Participants
    157
    164
    No statistical analyses for this end point

    Secondary: Clinical Fracture Rate: Number of Participants With Bone Fractures

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    End point title
    Clinical Fracture Rate: Number of Participants With Bone Fractures
    End point description
    Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.
    End point type
    Secondary
    End point timeframe
    8 years
    End point values
    Exemestane Anastrozole
    Number of subjects analysed
    3789
    3787
    Units: Participants
    358
    354
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 years
    Adverse event reporting additional description
    Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NCI CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Exemestane
    Reporting group description
    Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally

    Reporting group title
    Anastrozole
    Reporting group description
    Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally

    Serious adverse events
    Exemestane Anastrozole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 3761 (0.51%)
    7 / 3759 (0.19%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Thrombosis/thrombus/embolism
         subjects affected / exposed
    1 / 3761 (0.03%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Bilirubin
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Creatinine
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cTnI
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac ischemia/infarction
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular systolic dysfunction
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restrictive cardiomyopathy
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraven.arrhyth. Atrial flutter
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventric.arrhyth. Trigeminy
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    CNS ischemia
         subjects affected / exposed
    1 / 3761 (0.03%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurology - Other
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy-motor
         subjects affected / exposed
    0 / 3761 (0.00%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy: cranial CN VIII
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech impairment
         subjects affected / exposed
    0 / 3761 (0.00%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 3761 (0.00%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blurred vision
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nyctalopia
         subjects affected / exposed
    0 / 3761 (0.00%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular - Other
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Incontinence, urinary
         subjects affected / exposed
    0 / 3761 (0.00%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 3761 (0.03%)
    0 / 3759 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 3761 (0.00%)
    1 / 3759 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Exemestane Anastrozole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3556 / 3761 (94.55%)
    3543 / 3759 (94.25%)
    Vascular disorders
    Hot flashes
         subjects affected / exposed
    2086 / 3761 (55.46%)
    2138 / 3759 (56.88%)
         occurrences all number
    6532
    6435
    Hypertension
         subjects affected / exposed
    300 / 3761 (7.98%)
    326 / 3759 (8.67%)
         occurrences all number
    462
    503
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    290 / 3761 (7.71%)
    292 / 3759 (7.77%)
         occurrences all number
    326
    337
    Investigations
    Cholesterol
         subjects affected / exposed
    591 / 3761 (15.71%)
    677 / 3759 (18.01%)
         occurrences all number
    909
    1143
    Weight gain
         subjects affected / exposed
    257 / 3761 (6.83%)
    286 / 3759 (7.61%)
         occurrences all number
    400
    420
    Weight loss
         subjects affected / exposed
    229 / 3761 (6.09%)
    218 / 3759 (5.80%)
         occurrences all number
    309
    280
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    671 / 3761 (17.84%)
    666 / 3759 (17.72%)
         occurrences all number
    1323
    1267
    Dyspnea
         subjects affected / exposed
    656 / 3761 (17.44%)
    652 / 3759 (17.35%)
         occurrences all number
    1359
    1428
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    526 / 3761 (13.99%)
    504 / 3759 (13.41%)
         occurrences all number
    872
    923
    Neuropathy-sensory
         subjects affected / exposed
    576 / 3761 (15.32%)
    528 / 3759 (14.05%)
         occurrences all number
    1247
    1096
    Pain Head/headache
         subjects affected / exposed
    414 / 3761 (11.01%)
    399 / 3759 (10.61%)
         occurrences all number
    780
    742
    General disorders and administration site conditions
    Edema: limb
         subjects affected / exposed
    749 / 3761 (19.91%)
    760 / 3759 (20.22%)
         occurrences all number
    1531
    1590
    Fatigue
         subjects affected / exposed
    1697 / 3761 (45.12%)
    1749 / 3759 (46.53%)
         occurrences all number
    4458
    4378
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    574 / 3761 (15.26%)
    521 / 3759 (13.86%)
         occurrences all number
    1285
    1072
    Mood alteration Anxiety
         subjects affected / exposed
    258 / 3761 (6.86%)
    229 / 3759 (6.09%)
         occurrences all number
    481
    418
    Mood alteration Depression
         subjects affected / exposed
    374 / 3761 (9.94%)
    377 / 3759 (10.03%)
         occurrences all number
    707
    659
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    614 / 3761 (16.33%)
    606 / 3759 (16.12%)
         occurrences all number
    1234
    1219
    Diarrhea
         subjects affected / exposed
    464 / 3761 (12.34%)
    414 / 3759 (11.01%)
         occurrences all number
    781
    665
    Flatulence
         subjects affected / exposed
    399 / 3761 (10.61%)
    363 / 3759 (9.66%)
         occurrences all number
    818
    808
    Heartburn
         subjects affected / exposed
    574 / 3761 (15.26%)
    556 / 3759 (14.79%)
         occurrences all number
    1128
    1084
    Nausea
         subjects affected / exposed
    436 / 3761 (11.59%)
    442 / 3759 (11.76%)
         occurrences all number
    630
    661
    Pain Abdomen NOS
         subjects affected / exposed
    202 / 3761 (5.37%)
    220 / 3759 (5.85%)
         occurrences all number
    293
    294
    Reproductive system and breast disorders
    Pain Breast
         subjects affected / exposed
    288 / 3761 (7.66%)
    312 / 3759 (8.30%)
         occurrences all number
    453
    516
    Vaginal dryness
         subjects affected / exposed
    248 / 3761 (6.59%)
    260 / 3759 (6.92%)
         occurrences all number
    526
    586
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    235 / 3761 (6.25%)
    212 / 3759 (5.64%)
         occurrences all number
    418
    371
    Rash
         subjects affected / exposed
    474 / 3761 (12.60%)
    437 / 3759 (11.63%)
         occurrences all number
    721
    626
    Sweating
         subjects affected / exposed
    626 / 3761 (16.64%)
    603 / 3759 (16.04%)
         occurrences all number
    1486
    1324
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    264 / 3761 (7.02%)
    242 / 3759 (6.44%)
         occurrences all number
    481
    468
    Osteoporosis
         subjects affected / exposed
    1243 / 3761 (33.05%)
    1369 / 3759 (36.42%)
         occurrences all number
    1916
    2134
    Pain Back
         subjects affected / exposed
    480 / 3761 (12.76%)
    504 / 3759 (13.41%)
         occurrences all number
    835
    824
    Pain Bone
         subjects affected / exposed
    381 / 3761 (10.13%)
    410 / 3759 (10.91%)
         occurrences all number
    586
    678
    Pain Extremity-limb
         subjects affected / exposed
    468 / 3761 (12.44%)
    511 / 3759 (13.59%)
         occurrences all number
    750
    796
    Pain Joint
         subjects affected / exposed
    2085 / 3761 (55.44%)
    2086 / 3759 (55.49%)
         occurrences all number
    5539
    5467
    Pain Muscle
         subjects affected / exposed
    667 / 3761 (17.73%)
    629 / 3759 (16.73%)
         occurrences all number
    1150
    1110
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    238 / 3761 (6.33%)
    249 / 3759 (6.62%)
         occurrences all number
    360
    387
    Hyperglycemia
         subjects affected / exposed
    347 / 3761 (9.23%)
    373 / 3759 (9.92%)
         occurrences all number
    608
    673

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2005
    - Increase in sample size from 5800 to 6840 - Allowed use of Herceptin (see also prior memo dated June 06, 2005) - Inclusion of patients with LCIS only at the surgical margin - Additional clarifications and updates according to newer scientific literature - Adaptation of the CRFs to the amended protocol
    03 Nov 2006
    This amendment primarily involves an update of each study drug’s safety information and removal of the details describing the dispensation frequency of the study treatment. The case report forms have not been revised.
    02 May 2007
    This amendment involves mainly a reduction in reporting to AdEERS for patients on Anastrozole following the classification of Anastrozole as commercial agent.
    09 Mar 2009
    This amendment involves primarily changes to the statistical section to add a futility analysis to the statistical analysis plan. It does not involve any changes to the patient information/informed consent.

    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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