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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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:2008-008698-69
    Sponsor's Protocol Code Number:CRAD001Y2301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-008698-69
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, de everolimus en combinación con exemestano, en el tratamiento de mujeres posmenopáusicas con cáncer de mama metastático o localmente avanzado con receptor estrogénico positivo, refractarias a letrozol o a anastrozol
    A.4.1Sponsor's protocol code numberCRAD001Y2301
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameeverolimus / RAD001
    D.3.2Product code RAD001
    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 159351-69-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 Yes
    D.2.1.1.1Trade name AROMASIL 25 mg comprimidos recubiertos
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNEXEMESTANO
    D.3.9.3Other descriptive nameEXEMESTANE
    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 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 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
    cáncer de mama metastático o localmente avanzado con receptor estrogénico positivo
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar el tratamiento de combinación de everolimus y exemestano con exemestano en monoterapia con respecto a la supervivencia libre de progresión en mujeres postmenopáusicas con cáncer de mama con receptor estrogénico positivo que es refractario a los NSAIs
    E.2.2Secondary objectives of the trial
    Objetivos secundarios principales:
    Comparar la supervivencia global (SG) entre los 2 grupos de tratamiento.
    Otros objetivos secundarios:
    Evaluar los dos grupos de tratamiento con respecto a
    Tasa de respuesta global (ORR)
    Periodo de tiempo hasta el deterioro del estado funcional del ECOG
    Seguridad
    Cambios en las puntuaciones de la QoL a lo largo del tiempo
    Tasa de beneficio clínico (CBR)
    Resumir el tiempo hasta la respuesta y la duración de la respuesta en los dos grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Mujeres adultas (&#8805; 18 años de edad) con cáncer de mama localmente avanzado o metastásico no aptas para tratamiento curativo con cirugía o radioterapia.
    Confirmación citológica o histológica de cáncer de mama con receptor estrogénico positivo (ER+).
    Mujeres posmenopáusicas. El estado posmenopáusico se define en el Apartado 5.1
    Enfermedad refractaria a inhibidores de la aromatasa no esteroideos (NSAI), definida como:
    1. Recurrencia mientras, o durante los 12 meses después del final del tratamiento adyuvante con letrozol o anastrozol, o
    2. Progresión mientras, o durante un mes después del final del tratamiento con letrozol o anastrozol para el cáncer de mama metastático o localmente avanzado.
    • Evidencia clínica o radiológica de recurrencia o progresión con la última terapia sistémica previa a la aleatorización.
    • Las pacientes deberán presentar:
    1. Por lo menos una lesión que pueda medirse con exactitud al menos en una dimensión &#61619; 20 mm, utilizando técnicas convencionales o &#61619; 10 mm con TAC helicoidal o RM o
    2. lesiones óseas: líticas o mixtas (líticas + escleróticas) en ausencia de enfermedad medible como se define en el Apartado 3.1.1
    • Función de coagulación y de la médula ósea adecuada (definido en el Apartado 5.1)
    • Función hepática adecuada (definido en el Apartado 5.1)
    • Función renal adecuada (definido en el Apartado 5.1)
    • Colesterol sérico en ayunas &#8804; 300 mg/dl o 7.75 mmol/L y triglicéridos en ayunas &#8804; 2.5 x ULN.
    Estado funcional del ECOG &#8804; 2
    Consentimiento informado por escrito obtenido antes de realizar cualquier procedimiento de selección y según las pautas locales.
    E.4Principal exclusion criteria
    Pacientes que sobreexpresen HER2 con análisis de laboratorio local (tinción IHC 3+ o hibridización in situ positiva).
    Pacientes sólo con lesiones no medibles que no sean metástasis óseas (por ejemplo, derrame pleural, ascitis, etc)
    Pacientes que hayan recibido más de un régimen de quimioterapia para el CMA.
    Tratamiento previo con exemestano o inhibidores de mTOR.
    Hipersensibilidad conocida a inhibidores de mTOR, por ejemplo, sirolimus (rapamicina).
    Otras enfermedades malignas durante los últimos cinco años previos a la aleatorización, con la excepción de carcinoma in situ adecuadamente tratado del cuello del útero, del útero, carcinoma de células escamosas o basal o cáncer cutáneo no melanoma.
    Radioterapia durante las cuatro semanas previas a la aleatorización, excepto en el caso de radioterapia localizada con fines analgésicos o para lesiones líticas con riesgo de fractura que puede finalizarse durante las dos semanas previas a la aleatorización. Las pacientes deberán haberse recuperado de las toxicidades de la radioterapia.
    Pacientes que actualmente reciban terapia sustitutiva hormonal, excepto que se suspenda antes de la aleatorización.
    Metástasis cerebrales sintomáticas u otras metástasis del SNC: Las metástasis cerebrales previamente tratadas se permiten siempre que la paciente no presente síntomas, la radioterapia previa para las metástasis cerebrales haya sido administrada más de cuatro semanas antes de la aleatorización y las dosis de corticosteroides sean bajas y estables durante por lo menos dos semanas antes de la aleatoriación.
    Pacientes que reciban agentes inmunosupresores concomitantes o uso crónico de corticosteroides en el momento del iniciar el estudio excepto en los casos descritos a continuación: se permiten aplicaciones tópicas, inhaladores, colirios o inyecciones locales. Se permiten pacientes en tratamiento con dosis bajas estables de corticosteroides durante por lo menos dos semanas antes de la aleatorización, en caso de metástasis cerebrales tratadas previamente.
    Carcinomatosis linfangítica bilateral difusa o metástasis pulmonar como la única manifestación de la enfermedad (>50% de afectación del pulmón), evidencia de metástasis calculada como más de un tercio del hígado, definido con ecografía y/o TAC.
    Pacientes con antecedentes conocidos de seropositividad frente al VIH. No se precisa la prueba de infección por VIH en la visita basal.
    Diátesis hemorrágica, activa o bajo medicación oral antivitamina K (excepto dosis bajas de warfarina y ácido acetilsalicílico o equivalente, mientras el INR sea &#61603; 2.0)
    Cualquier condición médica incontrolada y/o severa. Para más detalles, véase Apartado 5.2.
    Pacientes que sean tratadas con fármacos que se conozca que son inhibidores o inductores potentes de la isoenzima CYP3A (rifabutina, rifampicina, claritromicina, ketoconazol, itroconazol, voriconazol, ritinavir, telitromicina) durante los últimos 5 días antes de la aleatorización (la lista de medicaciones concomitantes prohibidas se encuentra en la Tabla 6-6).
    Antecedentes de incumplimiento de regímenes médicos.
    Pacientes que no quieran o que no puedan cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    la supervivencia libre de progresión (SLP), definida como el momento desde la fecha de aleatorización hasta la fecha de la primera progresión documentada o muerte por cualquier causa.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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 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
    Después de la progresión o después de la retirada del tratamiento del estudio, a las pacientes se les continuará controlando la supervivencia cada tres meses hasta que se registre un total de 392 muertes
    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 days3
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days3
    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 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 Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Revisar sección 11 "Procedimientos administrativos", subsección "Consentimiento informado"
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 343
    F.4.2.2In the whole clinical trial 705
    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 Decision2009-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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