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    Summary
    EudraCT Number:2011-002162-21
    Sponsor's Protocol Code Number:JECF-VITD-2011-01
    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:2012-02-10
    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 number2011-002162-21
    A.3Full title of the trial
    A phase II randomized, prospective, multicenter, placebo-controlled clinical trial to evaluate the chemopreventive effect of vitamin D in women at high risk of breast cancer.
    Ensayo clínico en fase II, aleatorizado, prospectivo, multicéntrico, controlado con placebo para evaluar el efecto quimiopreventivo de la vitamina D en mujeres con alto riesgo de cáncer de mama.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the effect of vitamin D in women at high risk of developing breast cancer.
    Estudio sobre el efecto de la vitamina D en mujeres con alto riesgo de desarrollar cáncer de mama.
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D
    Vitamina D
    A.4.1Sponsor's protocol code numberJECF-VITD-2011-01
    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 SponsorJosé Esteban Castelao Fernández
    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 supportMinisterio de Sanidad y Política Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComplexo Hospitalario Universitario de Vigo
    B.5.2Functional name of contact pointCarmen M. Redondo
    B.5.3 Address:
    B.5.3.1Street AddressHospital Meixoeiro, Despacho Investigadores, 2ª planta
    B.5.3.2Town/ cityVigo (Pontevedra)
    B.5.3.3Post code36214
    B.5.3.4CountrySpain
    B.5.4Telephone number349868111111665
    B.5.5Fax number34986811173
    B.5.6E-mailcarmen.redondo.marey@sergas.es
    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 VITAMINA D3 KERN PHARMA solución oleosa
    D.2.1.1.2Name of the Marketing Authorisation holderKERN PHARMA, S.L.
    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 Oral drops, solution
    D.3.4.1Specific paediatric formulation No
    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 INNCOLECALCIFEROL-COLESTEROL
    D.3.9.3Other descriptive nameCOLECALCIFEROL-COLESTEROL
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 typeVITAMIN
    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 placeboOral solution
    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
    Women at high risk of developing breast cancer
    Mujeres con alto riesgo de desarrollar cáncer de mama
    E.1.1.1Medical condition in easily understood language
    Women at high risk of developing breast cancer
    Mujeres con alto riesgo de desarrollar cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Determination of the effects of vitamin D intake on mammographic density in patients at high risk of developing breast cancer.
    Determinar los efectos del consumo de Vitamina D sobre la densidad mamográfica en pacientes con alto riesgo de desarrollar cáncer de mama.
    E.2.2Secondary objectives of the trial
    1. Provide preliminary information on the effects that VD consumption has on cellular atypia and breast cell proliferation, measured in ductal lavage samples.
    2. To assess the effects that VD consumption has on the estrogen expression, on the apoptosis and on the angiogenesis-related proteins found in ductal lavage samples.
    3. To determine the effects that VD consumption has on circulating hormones and growth factors levels in blood samples.
    4. To assess the effects that VD consumption has on lipid peroxidation levels in blood and ductal lavage samples.
    1. Proporcionar datos preliminares sobre los efectos que el consumo de VD tiene sobre la atipia celular y la proliferación celular de mama, medidas en muestras de lavado ductal.
    2. Evaluar los efectos que el consumo de VD tiene en la expresión de los estrógenos, la apoptosis y las proteínas relacionadas con la angiogénesis encontradas en muestras de lavado ductal.
    3. Determinar los efectos que el consumo de VD tiene sobre las hormonas circulantes y los niveles de factores de crecimiento en sangre.
    4. Evaluar los efectos que el consumo de VD tiene sobre los niveles de peroxidación lipídica en muestras de sangre y lavado ductal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women at high risk of developing breast cancer (BC) with at least one of the following criteria:
    a. - Five-year Gail risk of at least 1.7%, or a calculated risk of at least 5 times the average for their age group (20-29 years - calculated Gail risk of at least 5 years 0.1% 30-39 years - calculated Gail risk of at least 5 years 1.0% 40 and older - calculated Gail risk of at least 5 years 1.7%).
    b. - Known BRCA1/BRCA2 mutation carrier.
    c. - Family history of hereditary BC (at least 4 family members with BC at any age / at least 2 first degree relatives under 50 years diagnosed with BC / BC and ovarian cancer (OC) diagnosed in the same relative / at least 2 BC cases and 1 OC case at any age in the family).
    d. - previous biopsy showing atypical hyperplasia or lobular carcinoma in situ.
    e. - Women with a history of unilateral DCIS or invasive BC in remission (stage I) who have completed standard systemic therapy and local levels.
    f. - A history of OC in remission for more than 5 years.
    2. Serum creatinine <= 2.0mg/dl. Albumin 3.4-4.8 g / dl. Ca 8.6-10.6 mg / dl. 25-OHD <32ng/ml (suboptimal level).
    3. Total bilirubin <= 2.0 upper limit of normal (ULN), transaminases (SGOT and / or SGPT) and alkaline phosphatase up to 2.5 x ULN, AGC >=1500, platelets >=100,000. Hemoglobin >=8.0 g / dl.
    4. Baseline mammogram within 6 months prior to study entry with no interpretation of suspicious for malignancy (BIRADS 1-3).
    5. SWOG performance less than or equal to 1.
    6. All patients must provide written informed consent.
    7. Age > 18 years.
    8. Patients are not candidates for standard BC reduction strategies (prophylactic oophorectomy, prophylactic mastectomy, tamoxifene, raloxifene).
    9. Patients of childbearing potential should be using, during the study period, non-hormonal contraceptive method (condom, diaphragm or non-hormonal IUD).
    10. Commitment not to take supplements of vitamin D (other than those of the study). It allows up to 1000 mg Ca / day.
    11. No adverse reactions to VD.
    1. Mujeres con alto riesgo de desarrollar CM con al menos uno de los siguientes criterios:
    a.- Cinco años de riesgo Gail de al menos 1.7%, o un riesgo calculado de al menos 5 veces la media para su grupo de edad (20-29 años - riesgo Gail calculado de 5 años de al menos 0,1%, 30-39 años - riesgo Gail calculado de 5 años de al menos 1,0%, 40 años en adelante - riesgo Gail calculado de 5 años de al menos 1.7%).
    b.- Portadora conocida de mutaciones BRCA1/BRCA2.
    c.- Coherente con historia familiar de CM hereditario (al menos 4 familiares con CM a cualquier edad / al menos 2 familiares de primer grado diagnosticadas con CM 50 años / CM y cáncer de ovario (CO) diagnosticados en el mismo familiar / al menos 2 casos de CM y 1 caso de CO a cualquier edad en la familia).
    d.- Biopsia previa presentando hiperplasia atípica o carcinoma lobulillar in situ.
    e.- Mujeres con historia previa de carcinoma ductal in situ unilateral o CM invasivo en remisión (estadio I) que hayan completado la terapia sistémica y local estándar.
    f.- Antecedentes de CO en remisión de más de 5 años.
    2. Creatinina sérica <= 2.0mg/dl. Albumina 3.4-4.8 g/dl. Ca 8.6-10.6 mg/dl. 25-OHD<32ng/ml (suboptimal level).
    3. Bilirrubina total <= 2.0 límite superior normal (ULN), transaminasas (SGOT y/o SGPT) y alcalino fosfatasa hasta 2.5 x ULN, AGC >= 1500, plaquetas >= 100,000. Hemoglobina >= 8.0 g/dl.
    4. Mamografía inicial en los 6 meses previos a la entrada en el estudio con interpretación de no sospechoso de malignidad (BIRADS 1-3).
    5. Rendimiento SWOG inferior o igual a 1.
    6. Todos los pacientes deben proporcionar consentimiento informado por escrito.
    7. Edad >18 años.
    8. Los pacientes no serán candidatos para estrategias estándar de reducción de CM (ooforectomía profiláctica, mastectomía profiláctica, tamoxifén, raloxifén).
    9. Las pacientes en edad fértil deberán utilizar durante la duración del estudio un método anticonceptivo no hormonal (preservativo, diafragma o diu no hormonal).
    10. Compromiso de no tomar suplementos de vitamina D (aparte de los del estudio) durante la duración del mismo. Se permite tomar hasta 1000 mg de Ca/día.
    11. No presentar reacciones adversas a VD.
    E.4Principal exclusion criteria
    1. Current or within 6 months prior to baseline use of hormonal replacement therapy (antiestrogens, estrogen, SERM's, aromatase inhibitors or progestins, hormonal contraceptives).
    2. Chronic and concomitant use of anti-inflammatory drugs (aspirin, ibuprofen, indomethacin, etc.) or COX-2 inhibitors in the 3 months prior to baseline (chronic use is the use of more than 3 times per week).
    3. Underlying medical conditions, psychiatric or social barriers that prevent patient treatment.
    4. Patients with a history of other invasive malignancies, except nonmelanoma skin cancer, will be excluded if there is evidence of another malignancy within the past 5 years. Patients will also be excluded if their previous cancer treatment is contraindicated with this therapy protocol.
    5. Bilateral mastectomy.
    6. Ongoing pregnancy or lactation.
    7. Participation in another clinical trial with medication.
    1. Terapia hormonal actual o en los 6 meses previos al inicio del estudio (antiestrógenos, estrógenos, SERM's, progestinas o inhibidores de aromatasa, contraceptivos hormonales).
    2. Uso crónico concomitante de anti inflamatorios no esteroideos (aspirina, ibuprofeno, indometacina, etc.) o inhibidores de COX-2 en los 3 meses previos al inicio del estudio (uso crónico es el uso de más de 3 veces por semana).
    3. Condiciones médicas subyacentes, psiquiátricas o sociales que impidan al paciente recibir tratamiento.
    4. Serán excluidos los pacientes con historia de otras malignidades invasivas, a excepción del cáncer de piel no melanoma, si hay evidencias de la otra malignidad dentro de los últimos 5 años. Los pacientes también serán excluidos si el tratamiento de su cáncer previo está contraindicado con la terapia de este protocolo.
    5. Mastectomía bilateral.
    6. Embarazo o lactancia en curso.
    7. Participación en otro ensayo clínico con medicamentos.
    E.5 End points
    E.5.1Primary end point(s)
    The main objective of this study is to determine changes in mammographic density. A mammogram will be carried out at the beginning (up to 6 months before study entry) and at the end of the participation in the study (12 months). Mammograms will be evaluated using the method described by Ursin (Ursin et al. 1998) and results will be compared.
    El objetivo principal de este estudio es determinar cambios en la densidad mamográfica. Se realizará una mamografía al inicio del estudio (hasta 6 meses antes de la entrada en el estudio) y otra al final de la participación en el mismo (12 meses después), se compararán los resultados obtenidos en ambas. Las mamografías serán evaluadas usando el método descrito por Ursin (Ursin et al. 1998).
    E.5.1.1Timepoint(s) of evaluation of this end point
    It will be evaluated at the end of the participation in the study (12 months after the beginning of vitamin D supplementation intake).
    Se evaluará al final de la participación de la paciente en el estudio (12 meses después de comenzar a tomar el suplemento de vitamina D).
    E.5.2Secondary end point(s)
    Secondary objectives of this study will evaluate changes in levels of circulating hormones, growth factors and markers of lipid peroxidation in blood samples (E1, E2, E1S, testosterone, DHEA-S, SHBG, prolactin, FSH, IGF-1 and IGFBP3). These levels will be determined at the beginning, at the end and every six months while participating in the study using chemo/electroluminescence, immunoenzymatic and radioisotopic techniques. Changes in levels of lipid peroxidation markers, cell proliferation and proteins involved in estrogen expression, apoptosis and angiogenesis (PCNA, Ki-67, SPF, cyclin D, caspase-3, bcl-2, p21 , bax, COX-2, VEGF, FGF, EGF, F2-isoprostanes, PS2, cathepsin D, CP15 and apolipoprotein D) will also be evaluated. They will be determined at the beginning and end of study using immunohistochemical and spectrophotometric techniques. Changes in cellular atypia (measured at the beginning and end of study using standard cytological techniques) will also be assesed.
    Determination of the VD levels will be carried out at the beginning, the end and every 3 months during participation in the study using chemoluminescence techniques.
    Los objetivos secundarios de este estudio evaluarán cambios en los niveles de hormonas circulantes, factores de crecimiento y marcadores de peroxidación lipídica en muestras de sangre (E1, E2, E1S, testosterona, DHEA-S, SHBG, prolactina, FSH, IGF-1 e IGFBP3). Serán determinados al inicio, al fin y cada seis meses durante la participación en el estudio usando técnicas de quimio/electroluminiscencia y técnicas inmunoenzimáticas o radioisotópicas. Se evaluarán también cambios en los niveles de marcadores de peroxidación lipídica, proliferación celular y de proteínas relacionadas con la expresión de los estrógenos, apoptosis y angiogénesis (PCNA; Ki-67, SPF, ciclina D, caspasa-3, bcl-2, p21, bax, COX-2, VEGF, FGF, EGF, F2-isoprostanos, PS2, catepsina D, CP15 y apolipoproteína D). Serán determinados al principio y al fin del estudio usando técnicas inmunohistoquímicas y de espectrofotometría. Se evaluarán cambios en la atipia celular (cuantificada al principio y al fin del estudio usando técnicas citológicas standard).
    Se determinarán también los niveles de VD al inicio, al fin y cada 3 meses durante la participación en el estudio usando técnicas de quimioluminiscencia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes in levels of circulating hormones, growth factors and markers of lipid peroxidation will be determined by comparing the initial levels with levels at 6 and 12 months after initiation of study participation.
    Changes in the levels of lipid peroxidation, cell proliferation and protein expression associated with estrogen, apoptosis and angiogenesis as well as changes in cellular atypia will be assessed by comparing the values ​​of those markers at the beginning and end of participation in the study.
    Vitamin D levels will be assessed every three months and compared to the initial ones.
    Los cambios en los niveles de hormonas circulantes, factores de crecimiento y marcadores de peroxidación lipídica se determinarán comparando los niveles iniciales de los mismos con los niveles a los 6 y 12 meses del inicio de la participación en el estudio.
    Los cambios en los niveles de peroxidación lipídica, proliferación celular y de proteínas relacionadas con la expresión de los estrógenos, apoptosis y angiogénesis así como los cambios en la atipia celular se evaluarán comparando los valores de estos marcadores al inicio y al fin de la participación en el estudio.
    Los niveles de vitamina D se evaluarán cada tres meses y se compararán los niveles obtenidos con el valor inicial obtenido.
    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) 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 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 concerned2
    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 No
    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
    The end of a subject's participation in the study will take place on her last visit to the center (12 months after her first visit).
    El final de la participación de un sujeto en el estudio se producirá en su última visita al centro para la última toma de muestras.
    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
    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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state140
    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)
    It will not be different from that indicated in the normal clinical practice for women at high risk of breast cancer
    No será diferente del indicado en la práctica clínica diaria para mujeres con alto riesgo de cáncer de mama.
    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 Decision2012-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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