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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005230-18
    Sponsor's Protocol Code Number:MA.32
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-05-09
    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 number2011-005230-18
    A.3Full title of the trial
    A Phase III randomized trial of metformin versus placebo on recurrence and survival in early stage breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial of Metformin in Early Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    MA.32
    A.4.1Sponsor's protocol code numberMA.32
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01101438
    A.5.4Other Identifiers
    Name:SponsorNumber:MA.32
    Name:Institute of Cancer Research (ICR, EU Legal Rep)Number:CCR3761
    Name:ICR- Clinical Trials and Statistics UnitNumber:ICR-CTSU/2011/10034
    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 SponsorNCIC Clinical Trials Group
    B.1.3.4CountryCanada
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportCanadian Cancer Society Research Institute (CCSRI)
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportNational Institute of Health Grant
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportApotex (Supply of Study drug only)
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportCanadian Breast Cancer Foundation
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportBreast Cancer Research Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNCIC-Clinical Trials Group
    B.5.2Functional name of contact pointPhysician Coordinator
    B.5.3 Address:
    B.5.3.1Street Address10 Stuart Street, Queen's University
    B.5.3.2Town/ cityKingston, Ontario
    B.5.3.3Post codeK7L 3N6
    B.5.3.4CountryCanada
    B.5.4Telephone number001613-533-6430
    B.5.5Fax number001613-533-2814
    B.5.6E-mailWParulekar@ctg.queensu.ca
    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 APO-METFORMIN
    D.2.1.1.2Name of the Marketing Authorisation holderApotex Inc
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameAPO-METFORMIN
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNMetformin Hydrochloride
    D.3.9.1CAS number 1115-0-4
    D.3.9.3Other descriptive nameAPO-METFORMIN
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboTablet
    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
    Early 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 14.1
    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
    The MA.32 study will investigate whether adding 5 years of metformin treatment to standard of care treatment for breast cancer, decreases the likelihood of breast cancer returning.
    E.2.2Secondary objectives of the trial
    The additional research questions that the study asks are: 1. Does metformin improve overall survival and the length of time patients are free of cancer after completing their standard of care treatment? 2. Does metformin increase the length of time patients are free of cancer in certain types of breast cancer eg. those with hormone sensitive disease? 3. Does metformin, in the context of this trial, lead to changes in body mass index? 4. What are the quality of life implications? (US/Canadian centres only) 5. What adverse events or other medical events occur in the trial population 6. What can the tumour tissue and blood samples tell us about breast cancer, the role of metformin and how patients respond to treatment?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biological sub-studies will be an integrated component of the MA.32 clinical trial. Tumour blocks for evaluation of tumour related factors at baseline, as well as whole blood for DNA, serum and plasma for subsequent evaluation of biomarkers and for future research will be collected at baseline, 6 months post randomization and at the end of study. The sample collection for this component will be strongly encouraged but remains optional. Full details of these sub-studies are includies in Part B Sections 4 and 5.
    E.3Principal inclusion criteria
    1. Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. 2. All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. 3.Definitive surgery and/or chemotherapy must have been completed at least 4 weeks prior to randomization. 4. Adjuvant subjects with the following pT pN combinations are eligible: • pT1c, pN0 AND at least one of the following tumour characteristics: histologic grade 3, lymphovascular invasion, negative estrogen and progesterone receptors, HER2 positive, Oncotype Dx recurrence score > 25 (or if Oncotype Dx recurrence score is not available, Ki67 > 14%)OR • Subjects with pT2-3, pN0 OR • Subjects with pT1-3, pN1-3. The eligibility of neo-adjuvant subjects is assessed on the basis of cTNM. The same eligible TNM combinations apply. 5. Estrogen and progesterone receptor status must be known. 6. HER2 status must be known. 7. 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. 8. The following scans must have been performed between the first diagnosis and the time of randomization: • Chest X-Ray (or Chest CT) is mandatory • Bone scans (with x-rays of abnormal areas) if symptoms of metastatic disease • Abdominal imaging is required if liver function tests are abnormal or if there are symptoms of metastatic disease 9. Adequate haematology (exact definition in protocol) 10. Adequate biochemistry (exact definition in protocol) 11. ECOG Performance Status of 0,1 or 2 12. Age > 18 and < 75 13. Subjects must be accessible for treatment and follow-up. 14. Patients must have provided written informed consent
    E.4Principal exclusion criteria
    1. Subjects with a history of other malignancies (exact definition in protocol). 2. Subjects with locally recurrent or metastatic breast carcinoma. 3. Subjects whose axillary node status is unknown. 4. Known diabetes (type 1 or 2) or baseline fasting glucose > 7.0 mmol/L (126 mg/dL). 5. Known hypersensitivity or intolerance of metformin. 6. Any condition associated with increased risk of metformin-associated lactic acidosis (exact definition in protocol). 7. Currently taking metformin, sulfonylureas, thiazolidenediones or insulin for any reason. 8. Current or planned pregnancy or lactation in women of child-bearing potential (confirmed by negative pregnancy test within 7 days of randomization). Men should not father a child. Birth control requirements are defined in the protocol. 9. Concurrent or planned participation in randomized trials of weight loss, exercise or trials targeting insulin and its pathways.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is Invasive Disease Free Survival defined as the time from randomisation to the time of any of the following events: - ipsilateral and contralateral invasive breast tumour, - local/regional invasive recurrence, - distant recurrence, - death from breast cancer, - death from non-breast cancer cause, - death from unknown cause, - diagnosis of a second primary invasive non-breast cancer (except squamous cell carcinoma and basal cell carcinoma of skin, completely excised and presumed cured).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During and after protocol treatment patients will be followed up with annual mammogram and clinic visits according to standard practise. These investigations will identify those patients with events meeting the definition of Invasive disease Free survival.
    E.5.2Secondary end point(s)
    The secondary endpoints of the trial include: - Overall survival - Distant relapse free survival - Breast cancer free interval And other medical endpoints including one or more of the following: - Diabetes - Cardiovascular hospitalisation - Changes in BMI
    E.5.2.1Timepoint(s) of evaluation of this end point
    During and after protocol treatment patients will be followed up with annual mammogram and clinic visits according to standard practise. These investigations will identify those patients with events meeting the definition of the secondary endpoints listed. Overall survival is defined as the the time from randomisation to the time of death from any cause. Distant relapse free survival is defined as the time from randomisation to the time of distant recurrence or death from any cause. Breast cancer free interval is defined as the time from randomisation to the time of invasive ipsilateral breast tumour recurrence, local/regional invasive recurrence, distant recurrence, death from breast cancer, invasive contralateral cancer, ipsilateral DCIS, contralateral DCIS.
    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 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned26
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Switzerland
    United Kingdom
    United States
    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
    The end of trial is defined as the date of last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 3582
    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)
    Following completion of trial treatment patients will be followed up in clinics according to their routine care. In addition, patients will continue to have annual mammograms to monitor for signs of recurrence/disease progression. Any side effects relating to the completed study treatment will also be followed up annually.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation n/a - see G5
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-31
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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