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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2006-004332-79
    Sponsor's Protocol Code Number:GINECO-BR105
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004332-79
    A.3Full title of the trial
    "Essai multicentrique de phase II randomisé évaluant la tolérance et l'efficacité du tamoxifène seul versus association Tamoxifène-RAD001 (Everolimus), chez les patientes atteintes de cancer du sein métastatique résistant aux anti-aromatases"
    A.3.2Name or abbreviated title of the trial where available
    TAMRAD
    A.4.1Sponsor's protocol code numberGINECO-BR105
    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 SponsorARCAGY
    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 RoleComparator
    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.2.1.2Country 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 nameTAMOXIFENE
    D.3.4Pharmaceutical form 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 INNTamoxifene citrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    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 No
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    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 nameRAD001
    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 INNEVEROLIMUS
    D.3.9.1CAS number 159 351-69-6
    D.3.9.2Current sponsor codeRAD001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic 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
    Evaluer pour les 2 schémas d’administration le pourcentage de bénéfice clinique à 24 semaines

    To assess whether concomitent use of RAD001 and tamoxifene allow better results of 2nd line hormonotherapy in metastatic breast cancer. This question is of great clinical importance as most of the metastatic patients with a tumor expressing hormonal receptor will already have received aromatase inhibitor as an adjuvant therapy and will correspond to the target population of this study.

    Clinical benefit percentage evaluation at 24 weeks of treatment for the two arms of this study (Tamoxifen vs Tamoxifen+RAD001)
    E.2.2Secondary objectives of the trial
    Evaluation dans les 2 bras :
    1) des taux de réponses partielle et complète selon les critères RECIST, et des durées de réponses
    2) de la nature, la fréquence et la sévérité des effets secondaires appréciées selon les critères CTCAE (version 3.0)
    3) du temps jusqu’à progression (TTP)
    4) de la survie globale.

    Ainsi que dans la majorité des centres, analyse des altérations génétiques sur l'ADN sérique.

    Secondary objectives of the trial include evaluation of partial and complete response rate in the two arms using RECIST criteria, and response duration. This trial will also focus on safety and toxicity and side effects using CTCAE (version 3.0) criteria. Progression-free survival and global survival will also be carefully studied.
    For the biology part, genetic alterations will be screened on serum DNA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 ans
    • Adénocarcinome mammaire histologiquement prouvé
    • Récepteurs hormonaux positifs aux oestrogènes et/ou à la progestérone et ne surexprimant pas HER2
    • Patiente en 1ère ou 2ème ligne d'hormonothérapie en situation métastatique
    • Patiente ayant déjà reçu un traitement par anti-aromatase en situation adjuvante ou métastatique
    • Présence d’une ou de plusieurs lésion(s) métastatique(s) mesurable(s) ou évaluables(s). En cas de lésion(s) osseuse(s) isolée(s) : critères minimum pour les considérer comme lésion(s) cibles : hyperfixation(s) scintigraphique(s) associée(s) à au moins l’un des critères suivants :
    o preuve cytologique ou histologique
    o image radiographique typique
    o élévation du CA15-3
    • Index de performance inférieur ou égal à 2 selon l’échelle ECOG
    • Fonctions biologiques satisfaisantes
    o Polynucléaires neutrophiles ≥ 1,5.109/L
    o Plaquettes ≥ 100.109/L
    o Clairance de la créatinine ≥ 30 mL/min
    o Bilirubine totale <= 1,5 fois la limite supérieure de la normale (LSN)
    o Phosphatases alcalines <= 2,5 x LSN
    o ALAT, ASAT <= 1,5 x LNS en absence de métastases hépatiques ou <= 3 x LSN en cas de métastases hépatiques
    • Consentement éclairé signé avant l’inclusion.
    E.4Principal exclusion criteria
    • Patiente présentant une tumeur surexprimant HER2 et devant être traitée par trastuzumab
    • Traitement antérieur par une chimiothérapie en situation métastatique (la chimiothérapie en situation adjuvante est autorisée)
    • Traitement antérieur par tamoxifène, sauf si le tamoxifène a été administré en situation adjuvante et arrêté au moins un an avant la rechute métastatique.
    • Traitement antérieur avec des médicaments expérimentaux (inhibiteur de mTOR ou de récepteur à tyrosine kinase).
    • Rechute tumorale uniquement locale et accessible à un traitement chirurgical
    • Patientes nécessitant une radiothérapie localisée immédiate à visée antalgique (l’inclusion dans l’étude ne devra avoir lieu qu’après la fin de la radiothérapie et quand l’état de la patiente sera stabilisé)
    • Métastases cérébrales non contrôlées, lymphangite carcinomateuse pulmonaire (plus de 50% d’envahissement), métastases hépatiques > 1/3 du foie (à l’échographie ou au scanner)
    • Antécédent de maladie thrombo-embolique
    • Antécédents de cancer en dehors des cancers in situ du col de l’utérus et du cancer de la peau guéris (non mélanome) ainsi que les antécédents de cancers datant de plus de 5 ans et considérés comme guéris.
    • Toute pathologie concomitante grave et /ou non contrôlée susceptible de compromettre la participation à l'étude (c'est-à-dire un diabète non contrôlé, une hypertension non contrôlée, une infection grave, une malnutrition profonde, un angor instable ou une insuffisance cardiaque congestive – classe III ou IV selon la New York Heart Association – des arythmies ventriculaires, une coronaropathie évolutive, un infarctus du myocarde au cours des six mois précédents, une pathologie hépatique ou rénale chronique, une ulcération évolutive du tractus digestif haut)
    • Séropositivité HIV
    • Patients présentant une affection cutanée, de muqueuses, oculaire ou gastro-intestinale de grade > 1
    • Anomalies biologiques de grade ≥ 3
    • Patientes ayant une hypersensibilité connue à l’évérolimus ou au sirolimus (rapamycine), ou au lactose (contenu dans les formulations de RAD001).
    • Patiente ne pouvant être suivie régulièrement pour des raisons familiales, géographiques, sociales ou psychologiques
    • Patiente dont l’altération de l’état mental ne lui permettrait pas de comprendre l’étude ou de donner son consentement éclairé.
    • Patientes avec des antécédents de mauvaise compliance à un traitement médical
    • Patiente enceinte ou allaitant ou en âge de procréer sans contraception efficace
    • Administration simultanée d’un autre médicament de chimiothérapie ou d’hormonothérapie ou anti-tumoral
    • Patientes ayant reçu un autre traitement en cours d'évaluation dans les 30 jours précédant la visite de screening.
    • Patientes traitées avec des molécules connues comme étant de forts inhibiteurs ou inducteurs des isoenzymes CYP3A (Rifabutine, Rifampicine, Clarithromycine, Ketoconazole, Itroconazole, Voriconazole, Ritinavir, Télithromycine) dans les 5 derniers jours précédant la randomisation
    • Patiente participant à un autre essai clinique qui pourrait interférer avec les objectifs de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    Pourcentage de patientes ayant un bénéfice clinique à 24 semaines après le début du traitement (Réponse complète + réponse partielle + stabilité selon les critères RECIST)
    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 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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    E.8.2.3.1Comparator description
    Tamoxifene seul ou Tamixifene + RAD001 (everolimus)
    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 No
    E.8.5.1Number of sites anticipated in the EEA50
    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 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
    18 mois d'inclusion + 6 mois de médiane de traitement + 3 ans de médiane de suivi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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 Decision2007-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-12
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