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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-003991-12
    Sponsor's Protocol Code Number:MREC02/8/70
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-12-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2004-003991-12
    A.3Full title of the trial
    International Breast Cancer Intervention Study II (Prevention). An international multi-centre study of anastrozole vs placebo in postmenopausal women at increased risk of breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International Breast Cancer Intervention Study II (Prevention). An international multi-centre study of anastrozole vs placebo in postmenopausal women at increased risk of breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    IBIS-II (Prevention)
    A.4.1Sponsor's protocol code numberMREC02/8/70
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN31488319
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQueen Mary, University of London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Arimidex
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameArimidex
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANASTROZOLE
    D.3.9.1CAS number 120511731
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if anastrozole is effective in preventing breast cancer in postmenopausal women at increased risk of the disease.
    E.2.2Secondary objectives of the trial
    To examine the role of anastrozole in preventing oestrogen receptor positive breast cancer.

    To examine the effect of anastrozole on breast cancer mortality.

    To examine the effect of anastrozole on other cancers, cardiovascular disease, fracture rates and non-breast cancer deaths.

    To examine tolerability and acceptability of side effects experienced by women on the study.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    IBIS-II Bone Substudy. A Randomised, Double-Blind Trial To Assess The Effects On Bone Mineral Density
    And Bone Biomarkers Of Anastrozole When Used To Prevent Breast Cancer In Postmenopausal Women.
    Version 15, May 2009.
    Aims of Bone Study:
    1) To quantify the changes in bone in the spine and femur in postmenopausal women treated with anastrozole
    compared with the placebo group.
    2) To evaluate the impact of bisphosphonate treatment on bone mineral density and bone metabolism in women
    taking anastrozole, and who are found to be osteoporotic or moderate to severely osteopenic at baseline.
    Bisphosphonate treatment will be required for women who are found to be osteoporotic at baseline, and will be
    a randomised option in women who are moderate to severely osteopenic at baseline.
    3) To explore the relationship between changes in levels of biochemical markers of bone metabolism with
    longer term changes in bone mineral density as measured by DXA, related to bone metabolism.
    IBIS-II Cognitive Function Substudy. A longitudinal study of the effects of anastrozole on cognition in postmenopausal
    women at increased risk of developing breast cancer. Version 5, June 2002.
    Aims:
    1) To determine whether measurable changes in coginitive performance can be detected in women in a breast
    cancer prevention trial (IBIS II), which compares anastrozole and placebo.
    2) To examine and compare the effect on cognition of anastrozole versus placebo.
    3) To investigate different rates of longitudinal change in cognition between the treatment arm and placebo arm.
    IBIS-II Body Composition Substudy. A longitudinal study of the effects of anastrozole on body composition in
    post-menopausal women at increased risk of developing breast cancer. Version 1, June 2003.
    Aims:
    To examine the effect of anastrozole on body composition amongst post-menopausal women at increased risk of
    developing breast cancer.
    To quantify changes in body fat and fat free mass (determined by dxa) and the relative distribution of fat from
    waist and hip circumferences amongst post-menopausal women treated with anstrozole compared with the
    placebo.
    E.3Principal inclusion criteria
    The trial is open to postmenopausal women between the ages of 40 and 70.

    Women aged 40-44 must have at least one of the following:
    Two or more 1st or 2nd degree relatives who developed breast cancer at age 50 or less
    1st degree relative with bilateral breast cancer who developed the 1st cancer at age 50 or less
    Nulliparous (or 1st birth age 30 or above) and 1st degree relative who developed breast cancer at age 40 or above
    Benign biopsy with proliferative disease and 1st degree relative who developed breast cancer at age 40 or less.

    Women aged 45-70 must have at least one of the following:
    1st degree relative who developed breast cancer at age 50 or less, or who developed bilateral breast cancer at any age
    Two or more 1st or 2nd degree relatives who developed breast or ovarian cancer.
    Nulliparous (or 1st birth at age 30 or above) and 1st degree relative who developed breast cancer
    Benign biopsy with proliferative disease and 1st degree relative who developed breast cancer
    Mammographic opacityof at least 50% in absence of HRT use within last 3 months

    If 60-70, may also have:
    1st degree relative with breast cancer at any age
    Age at menopause >= 55 yrs
    Nulliparous or age at 1st birth 30 or above

    In addition, women in all the age groups (40-70) who have had certain breast conditions are also eligible. These are:
    Lobular carcinoma in situ (LCIS)
    Atypical ductal or lobular hyperplasia in a benign lesion (ADH or LDH)
    Ductal carcinoma in situ (DCIS), diagnosed within 6 months prior to randomisation and treated by mastectomy, if ER or PgR positive (>5%)
    Women with 10 year risk of breast cancer greater than 5%, who do not fit into any of the above categories may also be eligible.
    E.4Principal exclusion criteria
    Premenopausal women.
    Any previous cancer in last 5 years (except non-melanoma skin cancer or in situ cancer of cervix).
    Current or previous tamoxifen or raloxifene or other SERMs use for more than 6 months in the last 5 years. Women in IBIS-I are eligible if they have been off therapy for more than 5 years.
    Intention to continue to use oestrogen-based HRT.
    Had or planning to have prophylactic mastectomy.
    Women with T-scores of less than minus four or with more than two low trauma vertebral fractures.
    E.5 End points
    E.5.1Primary end point(s)
    Development of histologically confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    n/a
    E.5.2Secondary end point(s)
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 6000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Follow up by annual postal questionnaire for at least 5 years after the end of participation in the trial until LPLV. Flagging centrally for cancer incidence and mortality in the UK, similar existing tracking systems to be used in other countries.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2002-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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