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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2007-000687-24
    Sponsor's Protocol Code Number:ONCO 03/0701
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-02-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-000687-24
    A.3Full title of the trial
    Prévention du cancer du sein par le létrozole chez la femme ménopausée porteuse d'une mutation brca 1/2
    A.3.2Name or abbreviated title of the trial where available
    LIBER
    A.4.1Sponsor's protocol code numberONCO 03/0701
    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 SponsorFNCLCC
    B.1.3.4CountryFrance
    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 FÉMARA®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFÉMARA®
    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 INNlétrozole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    femmes porteuses d’une mutation des gènes BRCA1 ou 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006190
    E.1.2Term Breast cancer invasive NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de cet essai est d’évaluer la réduction d’incidence des cancers du sein invasifs chez des femmes ménopausées porteuses d’une mutation BRCA1/2.
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires de cet essai sont d’évaluer :
    - La réduction de l’incidence des cancers du sein in situ
    - La réduction du taux de récidive locale ou métastatique chez les femmes ayant eu un cancer du sein
    - L’incidence des cancers non mammaires, en particulier cancer de l’ovaire, du colon et de l’endomètre
    - La tolérance lipidique, cardiovasculaire et osseuse
    - La qualité de vie

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Femme indemne ou femme ayant eu un cancer du sein invasif unilatéral diagnostiqué plus de 5 ans auparavant et sans notion de récidive,
    - Femme porteuse d’une mutation BRCA1/2 délétère (mutation non-sens ou stop),
    - Age ≥ 40 et < 70
    - Indice de performance ECOG OMS < 2,
    - Femme ménopausée avec un statut de ménopause défini par un des critères suivants :
    - Age > 60 ans
    - Ovariectomie bilatérale
    - Age ≤ 60 non hystérectomisée et aménorrhée de plus de 12 mois
    - Age ≤ 60 avec antécédent d’hystérectomie et FSH > 20UI/L
    - Absence de cancer du sein à la mammographie ou l’IRM pratiquée dans l’année précédente,
    - Fonction hématologique normale (neutrophiles > 2 109 /l, plaquettes > 100 109 /l, hémoglobine > 10 g/dl),
    - Fonction hépatique normale (bilirubine<normale, ALAT, ASAT < 2,5 LSN),
    - Fonction rénale normale (clairance de la créatinine ≥ 60ml/min),
    - Fonctions vitales cardiovasculaire adéquates, absence d'antécédents d'infarctus du myocarde ou d'angine de poitrine, absence d'insuffisance cardiaque)
    - Absence d’ostéoporose à l’ostéodensitométrie dans les deux ans précédant l’entrée dans l’étude (fémur, rachis lombaire) : T score > -2 DS,
    - Absence de prise de traitement hormonal substitutif (THS) dans les 3 mois précédent l’entrée dans l’étude,
    - Absence de prise d’hormonothérapie dans l’année précédant l’entrée dans l’étude,
    - Information de la patiente et signature du consentement éclairé pour l’analyse génétique et pour la participation à l’étude
    E.4Principal exclusion criteria
    1) Absence de mutation délétère (stop ou non-sens répertoriée dans la banque du NCI)
    2) Suspicion de cancer du sein à l'examen clinique, la mammogrphie ou l'IRM
    3) Cancer du sein invasif diagnostiqué moins de 5 ans avant l'entrée dans l'essai
    4) Mastectomie bilatérale
    5) Antécédents de cancer du sein bilatéral
    6) Femme non ménopausée
    7) Patiente prenant ou ayant pris dans les 3 mois précédant l'entrée dans l'étude, un traitement hormonal substitutif de la ménopause
    8) Antécédent d'accident vasculaire cérébral
    9) Antécédent de cardiopathie ischémique
    10) Antécédent de fracture ostéoporotique
    11) Antécédent de cancer invasif dans les 5 années précédant l'entrée dans l'étude (à l'exception des cancers de la peau baso et spino-cellulaires et d'un épithélioma in situ du col utérin)
    12) Hypersensibilité au létrozole et aux escipients en particulier l'oxyde de titane
    13) Insuffisance hépatocellulaire
    14) Patiente déjà incluse dans un autre esai thérapeutique avec une molécule expériementale
    15) Personne privée de liberté ou sous tutelle ( y compris la curatelle)
    16) Personne dans l'impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
    E.5 End points
    E.5.1Primary end point(s)
    - Patientes sans antécédent de cancer du sein :
    Survie sans cancer du sein invasif à 5 ans, le diagnostic de cancer du sein reposant sur le diagnostic clinique ou radiologique et la preuve histologique apportée par biopsie ou l'exérèse chirurgicale.
    Le descriptif histologique devra comprendre :
    - la nature histologique (carcinome canalaire, lobulaire, autre histologie, lésion de carcinome in situ),
    - le grade histologique,
    - l’expression des récepteurs aux estrogènes et à la progestérone.


    - Patientes avec antécédent de cancer du sein :
    Survie sans cancer du sein invasif controlatéral, ou homolatéral à 5 ans sous réserve d’une revue des cas par des experts indépendants visant à discriminer les cas de nouveau cancer des cas de récidive locale.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 concerned8
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 state724
    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 Decision2007-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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