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    Summary
    EudraCT Number:2005-001893-28
    Sponsor's Protocol Code Number:IBCSG 30-04
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-21
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-001893-28
    A.3Full title of the trial
    A randomized phase III trial of exemestane versus anastrozole in postmenopausal women with receptor positive primary breast cancer
    A.3.2Name or abbreviated title of the trial where available
    MA.27
    A.4.1Sponsor's protocol code numberIBCSG 30-04
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInternational Breast Cancer Study Group (IBCSG)
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    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.3.2Product code not applicable
    D.3.4Pharmaceutical form 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 120511-73-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Information not present in EudraCT
    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 nameAromasin
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form 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 INNExemestane
    D.3.9.1CAS number 107868-30-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-menopausal women, histologically or cytologically confirmed, receptor-positive,
    adequately excised, primary breast cancer
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare event free survival (EFS) between postmenopausal women treated with exemestane or anastrozole as adjuvant therapy.
    E.2.2Secondary objectives of the trial
    To compare overall survival (OS) of postmenopausal women treated with exemestane with that of those receiving anastrozole as adjuvant therapy.

    To compare the time to distant recurrence for postmenopausal women treated with exemestane with that for women receiving anastrozole as adjuvant therapy.

    To compare the incidence of new primary contralateral breast cancer in the different treatment groups.

    To compare the incidence of all clinical fractures and specifically hip and vertebral fractures in the different treatment groups.

    To compare cardiovascular morbidity and mortality between exemestane and anastrozole.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients must have completely resected and histologically confirmed invasive breast cancer in the following TNM categories (AJCC Version 6): pT1, pT2 or pT3; pNx, pN0, pN1, pN2 or, only when the sole basis for this classification is the presence of 10 or more involved axillary nodes, pN3; M0. Surgical margins must be clear of invasive carcinoma and DCIS/LCIS. Patients with positive sentinel node biopsies must have subsequent axillary dissection to be eligible; negative sentinel node biopsies require no more axillary surgery for eligibility.

    The primary tumour must be receptor-positive i.e. ER and/or PgR positive (defined as a tumour receptor content of > 10 fmol/mg protein, or receptor positive by immunohistochemistry: ERICA or PgRICA)

    Postmenopausal status, prior to chemotherapy

    Patients with bilateral breast cancers are eligible only if their cancers are synchronous (diagnosed at the same time). One or both tumours need to have receptor positive markers. One could be negative.

    Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required.

    Radiologic investigations (bone scan, abdominal ultrasound or CT abdomen, chest x-ray) must be negative for metastases

    Patients must be randomized a minimum of 3 weeks and a maximum of 3 months after completion of chemotherapy. If no chemotherapy is given, patients must be enrolled no less than 3 weeks and no later than 3 months after primary surgery.

    Minimum life expectancy of 5 years.

    Hematology: WBC > 3.0 x 109/L or granulocytes (polymorphs + bands) > 1.5 x 109/L; platelets > 100 x 109/L within 4 weeks prior to randomization.

    Biochemistry: AST (SGOT) and/or ALT (SGPT) and alkaline phosphatase< 2 x the upper limit of institutional normal (UNL) unless imaging examinations have ruled out metastatic disease. Creatinine < 1.5 X UNL within 4 weeks prior to randomization.

    ECOG Performance Status 0, 1, or 2

    Patient must be able to swallow study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.

    Patients must be accessible for treatment and follow-up.

    Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.

    Protocol therapy must begin within 10 working days of randomization
    E.4Principal exclusion criteria
    Premenopausal status (premenopausal women excluded because aromatase inhibitors are not employed in this group as monotherapy).

    Patients with only receptor negative primary tumours.

    Patients with metachronous breast cancer (breast cancers diagnosed at different times).

    Less than 3 weeks or more than 3 months have elapsed since completion of chemotherapy; if no chemotherapy, less than 3 weeks or more than 3 months have elapsed since primary surgery.

    Patients with locally recurrent or metastatic breast cancer

    Patients with a history of other (non-breast) malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.

    Patients receiving concurrent hormonal therapy with estrogens, progesterones or androgens, or any selective estrogen receptor modulator (SERM). Vaginal atrophy refractory to local measures may be treated, at the discretion of the investigator, with intermittent vaginal estrogens.

    Patients having received prior treatment with a recognized aromatase inhibitor.

    Any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results.

    Prior treatment on a trial for breast cancer if permission has not been obtained from the sponsors of the original study for the patient to participate in MA.27. (MA.20 patients may participate in MA.27. MA.21 patients may not participate in MA.27.)

    Any prior treatment with tamoxifen or SERMs other than raloxifene. (Previous use of raloxifene is permitted, but the patient must have been off raloxifene for 3 weeks prior to randomization.) Any prior treatment with hormones or steroids (including over-the-counter products and supplements considered to have an estrogenic effect if not discontinued at least 3weeks prior to randomization

    Patients with a prior diagnosis of in situ carcinoma in the contralateral breast treated with partial mastectomy and/or hormonal therapy
    E.5 End points
    E.5.1Primary end point(s)
    Event free survival, 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Assuming we are interested in detecting a hazard ratio of 0.80 between exemestane and anastrozole, similar to that obtained for anastrozole vs. tamoxifen in receptor positive patients in ATAC with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the time of the final analysis. The total duration of this study would be about five years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 5800
    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 Decision2006-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-31
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