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    Summary
    EudraCT Number:2007-004169-16
    Sponsor's Protocol Code Number:ML20382
    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:2007-09-24
    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 number2007-004169-16
    A.3Full title of the trial
    Estudio fase II multicéntrico, abierto, no aleatorizado para evaluar la eficacia de una combinación con bevacizumab y quimioterapia secuencial, como tratamiento de pacientes con cáncer de mama operable HER2 negativo
    A.4.1Sponsor's protocol code numberML20382
    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 SponsorRoche Farma, 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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    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 Concentrate for solution for infusion
    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 INNbevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAb, VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    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
    Adenocarcinoma de mama operable HER2 negativo, de más de 2 cm de tamaño, no tratado previamente.
    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
    -Determinar la proporción de respuestas completas patológicas (RCp) en mama y ganglios linfáticos.
    E.2.2Secondary objectives of the trial
    -Determinar la proporción de respuestas clínicas objetivas (RO).
    -Estimar la proporción de cirugía conservadora de la mama.
    -Evaluar el perfil de seguridad del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Antes del comienzo de los procedimientos específicos del protocolo, deberá obtenerse y documentarse el consentimiento informado por escrito.
    2. Mujeres con diagnóstico histológico o citológico de adenocarcinoma de mama operable, HER2 negativo, > 2 cm de tamaño.
    3. Edad >18 años.
    4. Estadio funcional ECOG < 1.
    5. Esperanza de vida > 12 semanas.
    6. Documentación del estado de receptores hormonales: receptores estrogénicos (RE)/receptores de progesterona (RP).
    7. Función orgánica adecuada según los siguiente criterios:
    a. Reserva medular: recuento absoluto de neutrófilos (RAN) > 1,5 x 109L, plaquetas > 100 x 109L y hemoglobina > 9 g/dL (se permite la transfusión sanguínea).
    b. INR  1,5 y TTP  1,5 veces el límite superior del rango de normalidad (LSN) en los 7 días previos a la inclusión.
    c. Función hepática: bilirrubina < 1,5 x LSN, AST y ALT < 2,5 x LSN.
    d. Función renal: creatinina sérica < 1,25 x LSN, o aclaramiento de creatinina calculado > 50 mL/min y proteinuria determinada por tira reactiva < 2+. Las pacientes con > 2+ en el análisis basal, deberán presentar < 1 g de proteínas en orina de 24 h.
    e. Función cardiaca normal (FEVI).
    8. Capacidad para cumplir los requisitos del protocolo.
    9. Las mujeres con útero intacto (excepto si se ha constatado amenorrea durante al menos 24 meses) deberán presentar una prueba de embarazo negativa (en suero u orina) en los 7 días anteriores al inicio del tratamiento. Asimismo, deberán utilizar métodos anticonceptivos eficaces (anticonceptivos orales, dispositivo intrauterino, métodos anticonceptivos de barrera, conjuntamente con gel espermicida, o esterilización quirúrgica) durante el estudio y hasta 6 meses tras la finalización del tratamiento.
    E.4Principal exclusion criteria
    1. Enfermedad metastásica.
    2. Tratamiento previo para el cáncer de mama (quimio, radio u hormonoterapia).
    3. Mujeres embarazadas o en período de lactancia.
    4. Neuropatía periférica preexistente de grado >2 en el momento de la inclusión.
    5. Pacientes sometidos a procedimientos de cirugía mayor, biopsias abiertas o aquellos que hayan tenido lesiones traumáticas significativas dentro de los 28 días anteriores al comienzo del tratamiento del estudio, o pacientes en los que esté previsto un procedimiento de cirugía mayor que necesariamente tenga que realizarse durante el curso del estudio.
    6. Cirugía menor, incluida la inserción de un catéter, en las 24 horas previas a la infusión de bevacizumab.
    7. Tratamiento actual o reciente (en los 10 días previos a la infusión de bevacizumab) con dosis altas de aspirina (>325 mg/día).
    8. Uso actual o reciente (dentro de los diez días anteriores al comienzo del tratamiento con bevacizumab) de anticoagulantes orales o parenterales a dosis completas o agentes trombolíticos, con intención terapéutica. Sí se permite el empleo profiláctico de anticoagulantes.
    9. Historia o evidencia de diátesis hemorrágica o coagulopatía con riesgo de sangrado.
    10. Hipertensión arterial descontrolada (sistólica >150 mmHg y/o diastólica >100 mmHg).
    11. Enfermedad cardiovascular clínicamente significativa (es decir activa), por ejemplo, angina inestable, infarto de miocardio (< 6 meses previos a la inclusión), insuficiencia cardiaca congestiva de grado > II de la New York Heart Association (NYHA), arritmias cardiacas severas que requieran medicación durante el estudio que podría interferir con la administración regular del tratamiento de estudio, o que no estén controladas con la medicación.
    12. Heridas no cicatrizadas, ulcus péptico activo o fractura ósea.
    13. Historia de fístula abdominal, perforación gastrointestinal o absceso intra-abdominal en los 6 meses previos al reclutamiento.
    14. Cualquier otra enfermedad, alteración neurológica o metabólica, hallazgo de la exploración física o de laboratorio clínico que proporcione indicios razonables para sospechar una enfermedad o afección para la que esté contraindicado el uso de alguno de los fármacos del estudio o que coloque al paciente en riesgo alto de experimentar complicaciones relacionadas con el tratamiento.
    15. Patología psiquiátrica que a juicio del investigador pudiera interferir con el cumplimiento adecuado del tratamiento prescrito en el estudio.
    16. Necesidad de uso concomitante del agente antiviral sorivudina o análogos químicamente relacionados, tales como brivudina.
    17. Tratamiento en la actualidad con otro fármaco en investigación o participación en otro estudio de investigación en los 28 días previos a la inclusión en el estudio.
    18. Hipersensibilidad conocida a cualquiera de los fármacos del estudio o sus componentes.
    19. Pacientes con diagnóstico de otras enfermedades malignas en los últimos 5 años, excepto carcinoma de piel no-melanoma o carcinoma de cerviz uterino resecado.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluación de la eficacia

    Respuestas patológicas

    La variable principal del estudio es la proporción de respuestas patológicas completas (pCR) tras el tratamiento de inducción: para determinarla, se hará un estudio anatomopatológico de la pieza quirúrgica y se evaluará según los criterios de Miller y Payne. Sólo se considerará pCR en caso de ausencia de células tumorales invasivas en la mama y en los nódulos linfáticos.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Information not present in EudraCT
    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 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 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 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 concerned6
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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 Decision2007-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-07
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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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