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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2010-021067-32
    Sponsor's Protocol Code Number:BO25430(TDM4529g)
    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:2011-11-03
    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 number2010-021067-32
    A.3Full title of the trial
    Estudio multicéntrico, de extensión abierta, de Trastuzumab MCC DM1 (T-DM1) administrado como agente único o en combinación con otras terapias anticancerosas a pacientes tratadas previamente con un régimen de T DM1 equivalente en un estudio clínico de T-DM1 promocionado por Genentech y/o F. Hoffmann La Roche
    An open-label, multicenter extension study of trastuzumab-MCC-DM1 (T-DM1) administered as a single agent or in combination with other anti-cancer therapies in patients previously treated with the equivalent T-DM1 regimen in a Genentech and /or F. Hoffmann-La Roche Ltd. - sponsored T-DM1 study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio de Trastuzumab MCC DM1 (T-DM1) administrado como agente único o en combinación con otras terapias anticancerosas a pacientes tratadas previamente con T DM1 equivalente en un estudio clínico de T-DM1.
    A.4.1Sponsor's protocol code numberBO25430(TDM4529g)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportNA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltdhe Farma, S.A.
    B.5.2Functional name of contact pointHead, EU/ROW Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberNANANANA
    B.5.5Fax numberNANANANA
    B.5.6E-mailna@na.com
    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 nametrastuzumab-MCC-DM1 (TDM-1)
    D.3.2Product code RO5304020/F02
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNn/a
    D.3.9.1CAS number 1018448-65-1
    D.3.9.2Current sponsor codeRO5304020
    D.3.9.3Other descriptive nameT-DM1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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) 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 typeAnticuerpo conjugado conteniendo un anticuerpo monoclonal humanizado (trastuzumab) y DM1
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 namepertuzumab (rhuMAb 2C4)
    D.3.2Product code RO4368451/F01
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNpertuzumab
    D.3.9.1CAS number 380610-27-5
    D.3.9.2Current sponsor codeRO4368451
    D.3.9.3Other descriptive nameruhMAb 2C4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420
    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) 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 typeAnticuerpo monoclonal Humanizado
    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
    Cáncer de Mama Metastásico
    E.1.1.1Medical condition in easily understood language
    Cancer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Proporcionar tratamiento continuado con T-DM1 como agente único o en combinación con un taxano (paclitaxel o docetaxel) o con pertuzumab ± un taxano a pacientes con cáncer de mama HER2-positivo incluidas previamente en un estudio clínico de T-DM1 promocionado por Genentech/Roche y que han obtenido beneficios clínicos con el tratamiento administrado en el estudio original (las pacientes no deben mostrar indicios de progresión sistémica de la enfermedad y deben presentar un perfil de toxicidad aceptable tras completar el estudio original o en el momento de terminar dicho estudio).
    Recoger datos de seguridad con respecto a la administración a largo plazo de T DM1 como agente único o en combinación con un taxano o con pertuzumab ± taxano.
    E.2.2Secondary objectives of the trial
    No apliacable-no objetivos secundarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Las pacientes deben cumplir los criterios de inclusión siguientes para poder participar en este estudio:
    1. Haber firmado el formulario o formularios de consentimiento informado para este estudio
    2. Haber completado el tratamiento con T-DM1 como agente único o en combinación en el estudio original o continuar recibiendo tratamiento con T-DM1 como agente único o en combinación en el momento de concluir el estudio original y haber recibido la última dosis del fármaco del estudio en las 6 semanas previas a la fecha prevista para la administración de la primera dosis del tratamiento del estudio en el estudio de extensión.
    3. El investigador debe tener expectativas de que la paciente puede seguir beneficiándose del tratamiento continuado con T-DM1 como agente único o en combinación
    4. El valor basal de FEVI debe ser ³40%, determinado por ECO o MUGA, en los 30 días previos a la inclusión en el estudio
    Las pacientes cuya FEVI sea ³40%45% deben presentar un cambio absoluto de 10% con respecto al valor basal (utilizando como referencia la FEVI basal registrada en el estudio original, antes de iniciar el tratamiento con T-DM1).
    Véase el Anexo F para conocer las instrucciones a seguir en caso de que la falta de tecnecio 99 (Tc-99m) impida la realización de gammagrafías óseas o
    MUGA.
    5. Presentar un estado funcional ECOG de 02 (véase Anexo C)
    6. La función de órganos debe ser adecuada en los 7 días previos a la administración de la primera infusión del fármaco en investigación en este estudio, lo que se definirá por los valores siguientes:
    Recuento absoluto de neutrófilos 1000 células/mm3
    Recuento de plaquetas 75.000 células/mm3
    Bilirrubina total 1,5 ´límite superior de normalidad (LSN)
    SGOT (AST) y SGPT (ALT) 5 ´LSN
    Creatinina 1,8 ´LSN
    7. Las mujeres potencialmente fértiles y los varones con pareja potencialmente fértil deben estar dispuestos a utilizar un método anticonceptivo no hormonal altamente eficaz o dos métodos anticonceptivos no hormonales eficaces y a continuar utilizándolos durante el tratamiento del estudio y como mínimo hasta 6 meses después de administrar la última dosis del tratamiento del estudio Los pacientes varones cuyas parejas estén embarazadas deben utilizar preservativos durante todo el embarazo. Para más información, consúltense las Secciones 5.1.5 y 5.3.1.h.
    E.4Principal exclusion criteria
    1. Acontecimientos adversos que hayan requerido la suspensión del tratamiento con
    T-DM1 como agente único o en combinación en el estudio original
    2. Acontecimientos adversos graves producidos en el estudio original que no se hayan resuelto
    3. Progresión de la enfermedad (excepto en el caso de las metástasis cerebrales aisladas en determinadas condiciones, según se describe en la Sección 3.1) con
    T-DM1 como agente único o con un régimen que contenga T-DM1 durante el estudio original o antes de iniciar el estudio de extensión, con la excepción de los pacientes del estudio TDM4688g con progresión de la enfermedad temprana que
    recibieron tratamiento con pertuzumab+T-DM1 y no han tenido ninguna progresión
    de la enfermedad adicional en el régimen de tratamiento combinado.
    Es obligatorio realizar tomografía computerizada (TAC) o resonancia magnética
    (RM) de tórax, abdomen y pelvis en los 30 días previos a la inclusión en el estudio.
    Es obligatorio realizar TAC o RM cerebral (en los 30 días previos a la inclusión en el estudio) en caso de que exista sospecha clínica de metástasis cerebrales.
    4. Neuropatía periférica de grado ³3, de acuerdo con los Criterios de Terminología
    Común para Acontecimientos Adversos del National Cancer Institute (NCI
    CTCAE), Versión 3.0
    5. Antecedentes de insuficiencia cardíaca congestiva (ICC) sintomática (clases II-IV de la New York Heart Association [NYHA]), arritmia ventricular que requiera tratamiento, angina de pecho inestable en la actualidad o antecedentes de infarto de miocardio en los 6 meses previos a la inclusión en el estudio
    6. Disnea severa en reposo debida a complicaciones de la enfermedad neoplásica avanzada o que requiera actualmente oxigenoterapia continuada
    7. Enfermedad sistémica severa, no controlada en la actualidad (p. ej. Enfermedad cardiovascular, pulmonar o metabólica clínicamente significativa)
    8. Pacientes sometidas a un procedimiento de cirugía mayor o que hayan sufrido traumatismos significativos en los 28 días previos a la inclusión en el estudio o que previsiblemente precisarán cirugía mayor en el transcurso del tratamiento del estudio
    9. Pacientes que estén actualmente embarazadas o en período de lactancia
    10. Pacientes que hayan recibido cualquier tratamiento en investigación u otras terapias sistémicas destinadas al control de cáncer (p. ej. quimioterapia,
    Herceptin, etc.) desde la administración de la última dosis del fármaco del estudio en el estudio original
    11. Antecedentes de hipersensibilidad al tratamiento previo con T-DM1 o a cualquier agente utilizado en combinación con T-DM1 en el estudio original, que impida continuar administrando el tratamiento
    12. Pacientes que, de acuerdo con el criterio del investigador, sean incapaces o no estén dispuestas a cumplir los requisitos del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Incidencia de los acontecimientos adversos que requieren la suspensión o la reducción de la dosis de T-DM1
    Incidencia de todos los acontecimientos adversos y los acontecimientos adversos grave
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Bulgaria
    France
    Korea, Republic of
    Spain
    United Kingdom
    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
    El tratamiento con el protocolo de extensión puede continuar hasta que ocurra alguno de los siguientes puntos: progresión de la enfermedad (a excepción de metástasis cerebrales aisladas en determinadas condiciones, según se describe en la Sección 3.1) toxicidad inaceptable, cierre del estudio
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 100
    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)
    Los pacientes pueden recibir tratamiento en estudio hasta la progresión de la enfermedad (con la excepción de metástasis cerebrales aisladas, como se describe más adelante) o toxicidad inaceptable. Se prevé que el estudio permanezca abierto hasta después de que se haya producido la última visita del paciente. Los pacientes randomizados al grupo de tratamiento no conteniendo T-DM1 en los estudios de T-DM1, no son elegibles para este estudio.
    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 Decision2011-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-07
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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