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    Summary
    EudraCT Number:2015-001001-14
    Sponsor's Protocol Code Number:IEO240
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001001-14
    A.3Full title of the trial
    ¿A randomized placebo controlled phase II study with metformin in metabolic-unbalanced breast cancer survivors at higher risk for recurrence (MetBreCS)¿
    ¿Studio randomizzato in doppio cieco di fase II placebo controllato con metformina in pazienti con squilibrio metabolico in pregresso tumore della mammella ad alto rischio di recidiva (MetBreCS)¿
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of metformin in overweight breast cancer survivors at increased risk of recurrence
    Effetto della metformina in pazienti in sovrappeso a rischio di recidiva di tumore mammario
    A.3.2Name or abbreviated title of the trial where available
    MetBreCS
    MetBreCS
    A.4.1Sponsor's protocol code numberIEO240
    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 SponsorISTITUTO EUROPEO DI ONCOLOGIA
    B.1.3.4CountryItaly
    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 supportMinistero della salute - Ricerca corrente 2014
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo di Oncologia
    B.5.2Functional name of contact pointUfficio Studi Clinici e Attivit¿ Re
    B.5.3 Address:
    B.5.3.1Street Addressvia Adamello 16
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 57489848
    B.5.5Fax number+39 02 574898781
    B.5.6E-mailufficio.studiclinici@ieo.it
    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 METFORAL - 850 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORI GUIDOTTI S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    D.3.11.13.1Other medicinal product typeIPOGLICEMIZZANTE ORALE
    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 placeboCoated 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
    Metabolic-unbalanced breast cancer survivors at higher risk for recurrence (triple negative breast cancer, luminal B Her2 positive, non luminal HER2 positive)
    Pregresso tumore della mammella ad alto rischio di recidiva (tumore triplo negativo, tumore ormono responsivo con HER2 sovraespresso, tumore non ormono responsivo con HER2 sovraespresso) in soggetti con squilibrio metabolico
    E.1.1.1Medical condition in easily understood language
    Overweight breast cancer survivors at increased risk of recurrence
    Pazienti in sovrappeso a rischio di recidiva di tumore mammario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006190
    E.1.2Term Breast cancer invasive NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Metformin, given for 1 year, may decrease breast epithelial cells proliferation also in disease-free, metabolic unbalanced BC survivors.
    Confermare l¿efficacia della metformina (assunta per un anno) nella modulazione della proliferazione cellulare in pazienti con pregresso carcinoma della mammella ad alto rischio di recidiva
    E.2.2Secondary objectives of the trial
    The secondary endpoints include a series of analyses and biomarkers evaluations, i.e. the metformin effect on circulating serum biomarkers obtained by morning fasting blood samples and associated to insulin resistance and inflammatory condition (IGF-I, IGFBP-3, IGFBP-1, insulin, HOMA, lipid profile, SHBG, adiponectin and leptin, steroids, high sensitive-CRP) and molecular biomarkers (DNA epigenome-transcriptome analyses). Moreover, we will validate the metformin anticancer-action pathways and we will perform a series of targeted and untargeted metabolomics analyses. Finally, safety and toxicity of the drug will be considered as additional secondary endpoints.
    Modulazione di biomarcatori sierici associati a insulino resistenza e a stato infiammatorio (IGF-I, IGFBP-3, IGFBP-1, insulina, HOMA, profilo lipidico, SHBG, adiponectina e leptina, steroidi, us-CRP) e di biomarcatori molecolari (analisi di DNA epigenomico e transcriptomica).
    Validazione meccanismi di azione antitumorale della metformina e analisi metabolomica target e non target.
    Verr¿ valutata anche la sicurezza di impiego e la tossicit¿ del farmaco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre- and postmenopausal BC survivors (TN, or ER neg PgR neg Her2 pos, or Luminal B Her2 pos subtypes) who have completed any adjuvant therapy (not before 1 month from treatment cessation) without evidence of residual disease and with BMI > 25 kg/m2
    • Female, (age > 18 years).
    • Performance status = 0 (SWOG).
    • Pazienti con squilibrio metabolico (BMI >25 Kg/m2) e pregresso tumore della mammella (TN; or ERneg PgRneg Her2 pos; o Luminal B Her2 pos) che hanno completato le terapie adiuvanti (non prima di 1 mese dal completamento del trattamento) e non presentano accertata nuova presenza o residuo di malattia.
    • Donne in pre e postmenopausa (età > 18 anni).
    • Performance status = 0 (SWOG).
    E.4Principal exclusion criteria
    • Diabetic patients
    • Concomitant use of metformin
    • Bilateral breast cancer
    • Pazienti diabetiche
    • Uso concomitante di metformina
    • Tumore mammario bilaterale
    E.5 End points
    E.5.1Primary end point(s)
    change of Ki-67 in contralateral unaffected breast
    variazione del Ki67 misurato nella mammella controlaterale
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis on the primary endpoint will be performed at the end of the completion of the 12 month treatment period for all participants.
    L’analisi dell’ endpoint principale sarà effettuata alla fine del trattamento di 12 mesi di tutti i soggetti.
    E.5.2Secondary end point(s)
    To check the ability of the treatment to modulate various translational risk factors related to the target tissue and the host characteristics
    ¿ circulating and molecular biomarkers
    ¿ metabolomic analysis
    ¿ gene expression profile in adipose and epithelial breast tissue
    ¿ assessment of epigenetic changes in methylome patterns (DNA methylation)
    Verr¿ osservata la capacit¿ del trattamento di modulare una serie di biomarcatori (tessutali e circolanti) rischio-correlati:
    ¿ Biomarcatori circolanti di tipo ormono- e squilibrio metabolico-correlati
    ¿ Analisi metabolomiche specifiche ed aspecifiche
    ¿ Profilo dell¿espressione genica sul tessuto adiposo e sull¿epitelio mammario
    ¿ Modificazione epigenetiche (metilazione del DNA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint analysis will be available at the end of the third year
    L¿analisi sugli endpoint secondari sar¿ disponibile alla fine del terzo anno
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 166
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state236
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 236
    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)
    Participants will continue their follow-up according to their oncological status
    I partecipanti proseguiranno con i follow-up di routine previsti dalla loro condizione oncologica
    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 International Agency for Research on Cancer (IARC); Section of Nutrition and Metabolism
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation University of Bergen
    G.4.3.4Network Country Norway
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-01-02
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