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    Summary
    EudraCT Number:2007-002942-40
    Sponsor's Protocol Code Number:HPC 01/2007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-09-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-002942-40
    A.3Full title of the trial
    EXPLORATORY STUDY OF THE EFFECT OF THREE DIFFERENT LEVELS OF DOSES OF TAMOXIFEN (20, 40 Y 60 MG/DAY) OVER THE PLASMATIC CONCENTRATION OF THE MAIN ACTIVE TAMOXIFEN METABOLITE (ENDOXIFEN) IN PATIENTS WITH HORMONO-SENSITIVE BREAST CANCER, CARRIERS OF A CYP2D6 GENOTYPE “POOR METABOLIZER”.
    Estudio exploratorio del efecto de tres diferentes niveles de dosis de tamoxifeno (20, 40 y 60 mg/día) sobre la concentración plasmática de su principal metabolito activo (endoxifeno) en pacientes con cáncer de mama hormonodependiente portadoras de un genotipo de CYP2D6 “metabolizador lento”
    A.4.1Sponsor's protocol code numberHPC 01/2007
    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 SponsorFundación de la Comunidad Valenciana Hospital Provincial de Castellón
    B.1.3.4CountrySpain
    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.2.5The 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 nameTamoxifen
    D.3.2Product code Tamoxifen
    D.3.4Pharmaceutical form Pillules
    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 INNTAMOXIFEN
    D.3.9.1CAS number 10540291
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    WOMEN WITH HORMONE-DEPENDENT RESECTED PRIMARY BREAST CANCER, WITHOUT EVIDENCE OF METASTATIC DISEASE AND CARRIERS OF A CYP2D6 GENOTYPE “POOR METABOLIZER”.
    Cáncer de mama operado y sin diseminación metastásica (AJCC, 2002), con receptores hormonales positivos (receptor estrogénico RE y/o receptor de progesterona RP).Las pacientes deberán ser “lentas metabolizadoras” de CYP2D6
    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
    TO COMPARE PLASMATIC CONCENTRATIONS OF ENDOXIFEN IN STUDY PATIENTS (POOR METABOLIZER OF CYP2D6) AT THE THREE DIFFERENT LEVELS OF DOSES OF TAMOXIFEN (20, 40 Y 60 MG/DAY), TO THE CONTROL GROUP PATIENTS (EXTENSIVE METABOLIZERS OF CYP2D6) TREATED WITH STANDARD DOSES OF TAMOXIFEN.
    Objetivo primario:
    Comparar las concentraciones plasmáticas de endoxifeno de las pacientes del estudio (“metabolizadoras lentas” de CYP2D6) en los tres niveles de dosis de tamoxifeno, con las de las pacientes del grupo control (metabolizadoras rápidas de CYP2D6) en tratamiento con dosis convencionales de tamoxifeno.
    E.2.2Secondary objectives of the trial
    ANALYZE THE DISTRIBUTION OF POLYMORPHISMS (SNPS) IN THE CYP2D6 GENE IN CASTELLON POPULATION
    TO CONFIRM THAT THE WOMEN POOR METABOLIZERS OF CYP2D6 TREATED WITH STANDARD DOSES OF TAMOXIFEN HAVE LOWER CONCENTRATIONS OF ENDOXIFEN THAN THE EXTENSIVE METABOLIZERS.
    TO ANALYZE THE CYP2D6 GENOTYPE BY MEANS OF ALTERNATIVE METHODS (RFLPS AND TAQMAN) AND STUDY ITS RELIABILITY COMPARED TO THE STANDARD METHOD (AMPLICHIP CYP450)
    Objetivos secundarios:·
    Analizar la frecuencia de los polimorfismos genéticos de CYP2D6 en la población de Castellón.·
    Confirmar que las metabolizadoras lentas de CYP2D6 en tratamiento con dosis estándar de tamoxifeno tienen concentraciones de endoxifeno inferiores a las metabolizadoras rápidas a las mismas dosis.·
    Analizar el genotipo de CYP2D6 mediante métodos alternativos (RFLPs y Taqman) y estudiar su fiabilidad con respecto a la técnica estándar (AmpliChip CYP450
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollement into the trial:
    · Female,18 years of age or older.
    · Karnofsky performance score ≥ 80.
    · Histologically proven diagnosis of hormone-dependent breast cancer, stage I, II, or III (T1-3, Nx, M0), without evidence of metastatic disease.
    · Patient must have received definitive surgery treatment for breast cancer ( lumpectomy or mastectomy) and must have completed adjuvant or neo-adjuvant therapy if indicated.
    · Adjuvant treatment with tamoxifen must be indicated. At the inclusion time, the patient can be about starting the endocrine therapy or can have yet started it, but in this last case it must be planned to continue this treatment for at least 8 months more.
    · Patient with variant forms of the CYP2D6 gene corresponding to a poor metabolim of CYP2D6, as defined in ANEXO 2.
    · Women of childbearing potencial must be using a medically accepted method of contraception. Postmenopausic women (non-histerectomized) must remain amenorrheic during at least 12 months to be considered infertile (or at least 24 months in case of amenorrhea induced by adjuvant chemotherapy.
    · Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days before study inclusion.
    · Adequate haematological function as defined by haemoglobin >10g/dL, absolute neutrophil count >
    > 1,5 x 109/L, platelet count > 100 x 109/L); Adequate hepatic function as defined by: (ASAT/SGOT, ALAT/SGPTand alxaline phosphatase < 2,5 x ULN, total bilirubin < 2,5 mg/dl) and adequate renal function as defined by: creatinine < 2.0 mg/dl (within 15 days before inclusion).
    · Normal ECG (or without clinically relevant abnormality) within 8 weeks before inclusion.
    · Normal X-Ray (or without clinically relevant abnormality) within 8 weeks before inclusion.
    · Patients must sign written informed consent to performance the CYP2D6 genotype testing. Afterwards, if patient is eligible, she ought to sign a written informed consent to participate in the clinical trial in the 15 days prior to the inclusion.
    9.4. Criterios de inclusión
    1. Mujeres ³ 18 años.
    2. Índice del estado funcional de Karnofsky ≥ 80 (ECOG 0,1).
    3. Diagnóstico de cáncer de mama histológicamente demostrado y hormonosensible (con receptores de estrógeno (RE) y/o receptores de progesterona (RPg) positivos), con estadio I, II o III (T1-3, M0), sin evidencia de diseminación a distancia.
    4. La paciente debe haber recibido un tratamiento quirúrgico definitivo para el cáncer de mama operable, bien mastectomía o bien cirugía conservadora, y debe haber completado el tratamiento quimioterápico adyuvante (o neoadyuvante) si éste estuviera indicado.
    5. El tratamiento hormonal adyuvante con tamoxifeno debe estar indicado. En el momento de la inclusión en el estudio la paciente puede estar pendiente de iniciar la terapia hormonal o puede haberla iniciado ya, pero en este último caso debe estar planeado continuar la administración de tamoxifeno durante al menos 8 meses más.
    6. Pacientes con un genotipo de CYP 2D6 “metabolizador lento”, según la definición recogida en el ANEXO 2.
    7. Las mujeres en edad fértil deben utilizar un método anticonceptivo fiable y apropiado. Las mujeres postmenopáusicas (no histerectomizadas) deben haber permanecido amenorreicas durante al menos 12 meses para ser consideradas como no fértiles (o al menos 24 meses si la amenorrea ha sido inducida por el tratamiento quimioterápico adyuvante).
    8. Prueba de embarazo negativa en orina o suero en las mujeres con potencial de fertilidad, realizada en los 14 días anteriores a la inclusión en el estudio.
    9. Ausencia de anomalías significativas en los parámetros de laboratorio: hemograma (hemoglobina >10g/dL, neutrófilos > 1,5 x 109/L, plaquetas > 100 x 109/L); parámetros de función hepática (ASAT/SGOT, ALAT/SGPT y fosfatasa alcalina < 2,5 veces el límite superior de normalidad, bilirrubina total < 2,5 mg/dl) y creatinina < 2.0 mg/dl (en los 15 días previos al registro de la paciente)
    10. Electrocardiograma normal (o con anomalías no significativas) realizado en las 8 semanas previas al registro de la paciente.
    11. Radiografía de tórax normal (o sin hallazgos patológicos relevantes) realizado durante las 8 semanas previas al registro de la paciente.
    12. La paciente deberá firmar previamente un Consentimiento Informado para la realización del análisis del genotipo de CYP 2D6. Posteriormente, si la paciente es elegible, deberá firmar un Consentimiento Informado por escrito para participar en el ensayo clínico en los 15 días previos al registro de la paciente (ANEXO 1).
    E.4Principal exclusion criteria
    Patient with estrogen receptor AND progesterone receptor both negative breast cancer.
    Patients for whom tamoxifen is contraindicated ( history of deep vein thrombosis, endometrial hyperplasia, or abnormal vaginal bleeding), or known hypersensitivity to tamoxifen.
    Pregnant or breast feeding women. Patients of childbearing potential and serum or urine pregnancy test unknown or positive within 14 days before inclusion.
    Patients concurrently receiving any other hormone therapy or anti-cancer therapy.
    Concomitant treatment for hot flushes and sweats.
    Concurrent treatment with strong inhibitors of CYP2D6 as the selective inhibitors of serotonine Reuptake SSRI (particularly paroxetine y fluoxetine) or other less potent inhibitors of CYP2D6 (as sertraline and citalopram among the SSRI, doxepine, celecoxib, difenhidramine, clorfeniramine, amiodarone, cimetidine, haloperidol y ticlopidine).
    Concomitant oral treatment with coumarin-derivative anticoagulant therapy.
    Patients not willing or not being able to compliance with the protocol.

    9.5. Criterios de exclusión
    1. Pacientes con tumores con receptores de estrógeno (RE) y receptores de progesterona ambos negativos.
    2. Mujeres con contraindicación para recibir tamoxifeno (antecedentes de enfermedad tromboembólica, hiperplasia endometrial o síntomas ginecológicos anormales como metrorragia), así como hipersensibilidad conocida a tamoxifeno.
    3. Pacientes embarazadas o en período de lactancia. Pacientes con potencial de fertilidad y un resultado desconocido o positivo en la prueba de embarazo en orina o suero, realizada en los 14 días anteriores a la inclusión en el estudio.
    4. Tratamiento concomitante con otra terapia hormonal sistémica, o con fármacos citotóxicos.
    5. Tratamiento médico concomitante para los sofocos o acaloradas postmenopáusicas.
    6. Tratamiento concomitante con inhibidores potentes de CYP2D6 como los inhibidores selectivos de la recaptación de serotonina (ISRS, especialmente paroxetina y fluoxetina) u otros inhibidores menos potentes de CYP2D6 (como sertralina y citalopram entre los ISRS, doxepina, celecoxib, difenhidramina, clorfeniramina, amiodarona, cimetidina, haloperidol y ticlopidina).
    7. Pacientes con tratamiento anticoagulante con derivados de cumarina.
    8. Pacientes que no quieran o no puedan cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    COMPARISON OF PLASMATIC CONCENTRATIONS OF ENDOXIFEN
    Comparación de la concentración plasmática de endoxifeno
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The 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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    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 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 state20
    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 Decision2007-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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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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