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    The EU Clinical Trials Register currently displays   44235   clinical trials with a EudraCT protocol, of which   7336   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:2008-005544-17
    Sponsor's Protocol Code Number:EMR200038-010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-02-17
    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 number2008-005544-17
    A.3Full title of the trial
    A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally
    advanced, recurrent, or metastatic breast cancer
    STRIDE - STimulating immune Response In aDvanced brEast cancer

    Estudio aleatorizado de fase III, doble ciego, controlado, con Stimuvax® (L BLP25 o BLP25 vacuna liposomal) en combinación con tratamiento hormonal comparado a un tratamiento hormonal solo, como tratamiento de primera línea en mujeres post-menopáusicas con cáncer de mama localmente avanzado, inoperable, recurrente o metastásico con receptores de estrógenos (ER) positivos y/o receptores de progesterona (PgR) positivos
    STRIDE - STimulating immune Response In aDvanced brEast cancer (Respuesta inmunitaria estimulante en cáncer de mama avanzado)
    A.3.2Name or abbreviated title of the trial where available
    STRIDE
    A.4.1Sponsor's protocol code numberEMR200038-010
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 nameL-BLP25 (Stimuvax®; BLP25 liposome vaccine)
    D.3.2Product code EMD 531444
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEMD 531444
    D.3.9.3Other descriptive nameL-BLP25
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.77
    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) Yes
    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 Endoxana Injection 1g
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Health Care Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEndoxana Injection 1g
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclofosmamida
    D.3.9.1CAS number 50-18-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboPowder for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    tratamiento de primera línea en mujeres post-menopáusicas con cáncer de mama localmente avanzado, inoperable, recurrente o metastásico con receptores de estrógenos (ER) positivos y/o receptores de progesterona (PgR) positivos
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostración de la eficacia superior (determinada por el tiempo de SSP) de L-BLP25 en combinación con el tratamiento hormonal (TH) respecto a placebo más TH, cuando se utiliza como tratamiento de primera línea del cáncer de mama localmente avanzado, inoperable, recurrente o metastásico, y positivo para receptores hormonales (ER+ o PgR+).
    E.2.2Secondary objectives of the trial
    • Seguridad y tolerabilidad;
    • Tiempo de supervivencia global (SG);
    • Respuesta tumoral objetiva;
    • Duración de la respuesta;
    • Beneficio clínico;
    • Tiempo hasta la progresión (THP);
    • Tiempo hasta la quimioterapia;
    • Calidad de vida (CdV);
    • Utilización de recursos sanitarios (URS);
    • CA 15-3 en suero.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para la inclusión en el estudio, deben cumplirse todos los criterios de inclusión siguientes:
    • Consentimiento informado por escrito otorgado antes de realizar cualquier actividad relacionada con el estudio.
    • Paciente hospitalizada o ambulatoria.
    • Edad &#8805;18 años.
    • Post-menopáusica, definida por al menos uno (1) de los siguientes:
    - Sin menstruaciones espontáneas durante al menos cinco años.
    - Menstruaciones espontáneas en los cinco últimos años, pero amenorrea desde hace al menos 12 meses y lutropina (LH) y folitropina (FSH) dentro de los valores post-menopáusicos normales (las pacientes con amenorrea tras una histerectomía pero no sometidas a una salpingo-ovariectomía no pueden participar, salvo que presenten otras pruebas bioquímicas de menopausia, reflejadas por la supresión ovárica y los niveles plasmáticos de FSH y estradiol dentro del intervalo post-menopáusico).
    - Ovariectomía bilateral previa.
    - Castración e irradiación ovárica bilateral previa, con amenorrea desde al menos tres meses antes y niveles de FSH > 40 UI/l.
    - Sin período menstrual durante 12 meses o más y niveles séricos de estradiol dentro del intervalo post-menopáusico (&#8804; 22 pg/ml)
    • Carcinoma de mama primario, ER+ o PgR+, confirmado histológica o citológicamente (se puede aceptar el diagnóstico anatomopatológico institucional de CM).
    • Expresión de al menos uno de los siguientes cinco haplotipos de HLA, según la evaluación central mediante el genotipado de HLA en sangre: HLA-A2, -A3, -A11, -B7, o -B35.
    • CM localmente avanzado, recurrente o metastásico (la paciente debe presentar al menos una lesión no localizada en el hueso).
    • Enfermedad mensurable según RECIST e inoperable (no candidata a cirugía conservadora de la mama o mastectomía) sin una expectativa razonable de cirugía curativa ahora o en el futuro.
    • Estado funcional de ECOG (Eastern Cooperative Oncology Group) de 0 ó 1.
    • Esperanza de vida al menos de 12 semanas.
    • Función hematológica, hepática y renal adecuada en las dos semanas previas al inicio del tratamiento, definida por:
    - Leucocitos &#8805; 2500/mm3; recuento absoluto de neutrófilos &#8805; 1500/mm3; plaquetas &#8805; 100.000/mm3
    - Hemoglobina &#8805; 9 g/dl
    - Bilirrubina &#8804; 1,5 × el límite superior de la normalidad (LSN), o &#8804; 5 × LSN en caso de metástasis hepática.
    - Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) &#8804; 2,5 x LSN, o &#8804; 5 x LSN en caso de metástasis hepática.
    - Creatinina &#8804; 1,5 × LSN.
    - Cociente internacional normalizado (INR), tiempo de protrombina (TP) y tiempo de tromboplastina parcial (TTP) dentro del intervalo normal.
    • Voluntad de cumplir con los requisitos del protocolo del estudio.
    E.4Principal exclusion criteria
    Las pacientes no pueden participar en este estudio si cumplen uno o más de los siguientes criterios de exclusión:
    Estado de la enfermedad
    • EP durante el TH para cáncer de mama en estadio precoz (tratamiento adyuvante) o en los 12 meses siguientes a la finalización de ese tratamiento.
    • CM positivo para el receptor del factor de crecimiento epidérmico 2 humano (HER2+), definido como sigue:
    - Tinción de inmunohistoquímica (IHQ) de 3+ (tinción uniforme e intensa de la membrana de > 30% de las células tumorales invasivas), o
    - Resultado de hibridación in situ fluorescente (FISH) de > 6 copias del gen HER2 por núcleo, o
    - Cociente de &#61472;FISH (señales del gen HER2 frente a señales del cromosoma 17) > 2,2.
    Los datos históricos se confirmarán de forma sistemática por los laboratorios de anatomía patológica locales en caso de resultados históricos “equívocos” como sigue:
    o Mediante una prueba de FISH validada, si la expresión de la proteína HER2 es equívoca (p. ej., IHC 2+) o, si procede
    o Mediante una prueba de IHC validada, si la amplificación del gen HER2 es “equívoca” (p. ej., relación FISH 1,8-2,2 o copia del gen HER2 4,0-6,0)
    • Enfermedad autoinmunitaria que, en opinión del investigador, podría comprometer la seguridad de la paciente en este estudio (Se hará una excepción en el caso de la diabetes mellitus de tipo 1 bien controlada).
    • Inmunodeficiencia reconocida, incluidas las inmunodeficiencias celulares, hipogammaglobulinemia, o disgammaglobulinemia; inmunodeficiencias hereditarias o congénitas.
    • Infección por hepatitis B activa y comprobada o estado portador o infección por hepatitis C, infección por el virus de la inmunodeficiencia humana (VIH) activa y comprobada, o cualquier otro proceso infeccioso que, en opinión del investigador, pueda comprometer la capacidad de la paciente para obtener una respuesta inmunitaria o podría exponerle a la posibilidad de más efectos secundarios o que estos fueran más graves.
    • Antecedentes o presencia de neoplasia maligna que no sea el CM, excepto el cáncer de piel de tipo no melanoma tratado de forma curativa, carcinoma de cuello de útero in situ u otro cáncer tratado curativamente y sin indicios de enfermedad durante un mínimo de cinco años.
    Tratamientos previos
    • Administración de inmunoterapia (p. ej., interferones; factor de necrosis tumoral; interleucinas; factores de crecimiento, factor estimulante de colonias de macrófagos y granulocitos [GM-CSF], factor estimulante de colonias de granulocitos [G-CSF], factor estimulante de colonias de macrófagos [M-CSF], o anticuerpos monoclonales) en las cuatro semanas (28 días) anteriores a la aleatorización. Nota: Podrán participar las pacientes que hayan recibido anticuerpos monoclonales para técnicas de imagen.
    • Administración previa de fármacos sistémicos en fase de investigación (incluido el uso fuera de las indicaciones aprobadas de productos registrados) o cualquier tipo de tratamiento sistémico (quimioterapia, TH o inmunoterapia) para el cáncer de mama inoperable, localmente avanzado, recurrente o metastásico.
    • Radioterapia previa en el lugar del cáncer, si sólo se va a usar un lugar para la evaluación de la respuesta tumoral.
    Se permite el uso previo de bisfosfonatos o uso concomitante durante el tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal en este estudio es tiempo de SSP. Para este estudio, todas las TH de primera linea para cancer de mama fueron aprobadas en base a variables subrogadas( ya sea tasa de respuesta, tasa de respuesta y TTP, o TTP). En las guías acatuales, el tiempo de SSP normalmente se prefiere antes que el TTP como variable subrogada en estudios oncológicos. Como el tiempo de SSP tambien se considera una variable aceptable en situaciones donde terapias subsiguientes pueden tener un impacto sobre el tiempo de supervivencia global, se escogío el tiempo de SSP como variable primaria para este estudio.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Si el estudio no termina por alguna de las razaones dadas en la sección 5.3.3.3 del protocolo, se dará por terminado cuando se dé alguna de las siguientes circunstancias:
    - El último sujeto haya recibido la última dosis de medicación del estudio y haya realizado el seguimiento de seguridad tras 6 semanas
    - Se haya contestado a los objetivos del estudio
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1200
    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)
    Véase la sección 5.1.2 del protocolo: Los sujetos serán derivados a sus médicos respectivos para futuras opciones de tratamiento.
    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 Decision2009-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-07-29
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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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