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    Summary
    EudraCT Number:2011-005334-20
    Sponsor's Protocol Code Number:MO28047
    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:2012-02-22
    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 number2011-005334-20
    A.3Full title of the trial
    A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer
    ESTUDIO MULTICÉNTRICO, ABIERTO, CON UN SOLO GRUPO DE TRATAMIENTO, DE PERTUZUMAB EN COMBINACIÓN CON TRASTUZUMAB Y UN TAXANO COMO TRATAMIENTO DE PRIMERA LÍNEA DE PACIENTES CON CÁNCER DE MAMA AVANZADO (METASTÁSICO O LOCALMENTE RECURRENTE) HER2-POSITIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer
    ESTUDIO MULTICÉNTRICO, ABIERTO, CON UN SOLO GRUPO DE TRATAMIENTO, DE PERTUZUMAB EN COMBINACIÓN CON TRASTUZUMAB Y UN TAXANO COMO TRATAMIENTO DE PRIMERA LÍNEA DE PACIENTES CON CÁNCER DE MAMA AVANZADO (METASTÁSICO O LOCALMENTE RECURRENTE) HER2-POSITIVO
    A.3.2Name or abbreviated title of the trial where available
    PERUSE
    A.4.1Sponsor's protocol code numberMO28047
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    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 numberNA
    B.5.5Fax numberNA
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 namePertuzumab (rhuMAb 2C4)
    D.3.2Product code RO 4368451/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 namerhuMAb 2C4
    D.3.9.4EV Substance CodeSUB16455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    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
    Advanced breast cancer (metastatic or locally recurrent)
    Cáncer de mama avanzado (metastásico o localmente recurrente)
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer
    Cáncer de mama avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    To evaluate the safety and tolerability of pertuzumab in combination with trastuzumab and a taxane.
    Evaluar la seguridad y tolerancia de pertuzumab en combinación con trastuzumab y un taxano.
    E.2.2Secondary objectives of the trial
    To evaluate pertuzumab in combination with trastuzumab and a taxane with respect to:
    ?Progression-free survival (PFS)
    ?Overall survival (OS)
    ?Overall response rate (ORR)
    ?Clinical benefit rate (CBR)
    ?Duration of response
    ?Time to response
    ?Quality of life (Functional Assessment of Cancer Therapy- Breast [FACT-B] questionnaire for female patients only).
    Los objetivos secundarios de este estudio son los siguientes:
    ?Evaluar pertuzumab en combinación con trastuzumab y un taxano con respecto a lo siguiente:
    ?Supervivencia libre de progresión (SLP)
    ?Supervivencia global (SG)
    ?Índice de respuesta global (IRG)
    ?Índice de beneficio clínico (IBC)
    ?Duración de la respuesta
    ?Tiempo hasta la respuesta
    ?Calidad de vida (evaluada mediante el cuestionario Functional Assessment of Cancer Therapy-Breast [FACT-B], que se aplicará sólo a las mujeres participantes en el estudio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent approved by the relevant Institutional Review Board (IRB), or Independent Ethics Committee (IEC).
    2. Male or female patients aged 18 years or over.
    3. Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection.
    4. HER2-positive (defined as either IHC 3+ or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor and/or metastatic site if primary tumor not available (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4).
    5. At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Appendix 5).
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix 3).
    7. LVEF of at least 50%.
    8. Negative serum pregnancy test in women of childbearing potential (WOCBP; premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).
    9. For WOCBP and male patients with partners of CBP who are sexually active, agreement to use a highly effective, non-hormonal form of contraception (such as surgical sterilization) or two effective forms of non-hormonal contraception (such as a barrier method of contraception in conjunction with spermicidal jelly) during and for at least 6 months post-study treatment (refer to Section 4.5.2.1 for details).
    10. Life expectancy of at least 12 weeks.
    1.Firmar el consentimiento informado por escrito, aprobado por el Consejo Institucional de Revisión (CIR) o Comité Ético Independiente (CEI) pertinente.
    2.Ser varón o mujer y tener 18 años de edad o mayores.
    3.Presentar adenocarcinoma de mama confirmado y documentado histológica o citológicamente, con enfermedad metastásica o localmente recurrente que no se pueda tratar con resección con intención curativa.
    4.Estado HER2 positivo (definido por una puntuación 3+ en IHC o positividad en hibridación in situ [ISH]), determinado en el laboratorio local en el tumor primario y/o en una lesión metastásica, si no hubiese una muestra de tumor primario disponible (la positividad en ISH se define como una relación ? 2,0 del número de copias del gen HER2 al número de señales en CEP17, o en las pruebas en las que se emplea una sola sonda, un recuento del gen HER2 superior a 4).
    5.Presentar, al menos, una lesión medible y/o enfermedad no medible que sea evaluable de acuerdo con los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) versión 1.1 (Anexo 5).
    6.Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0, 1 o 2 (Anexo 3).
    7.FEVI, al menos, 50%.
    8.Las mujeres potencialmente fértiles (MPF; aquellas que sean premenopáusicas o postmenopáusicas con amenorrea desde hace menos de 12 meses y que no estén esterilizadas quirúrgicamente) deben presentar un resultado negativo en la prueba de embarazo en suero.
    9.Las MPF y los pacientes masculinos con parejas femeninas potencialmente fértiles que sean sexualmente activos deben comprometerse a utilizar un método anticonceptivo no hormonal altamente eficaz (tal como esterilización quirúrgica) o dos métodos anticonceptivos no hormonales eficaces (tales como métodos de barrera conjuntamente con gel espermicida) durante el tratamiento del estudio y como mínimo, hasta 6 meses después de su terminación (para más detalles, consúltese la Sección 4.5.2.1).
    10.Esperanza de vida de 12 semanas, como mínimo.
    E.4Principal exclusion criteria
    1. Previous systemic non-hormonal anticancer therapy for the metastatic or locally recurrent disease.
    2. Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence within 6 months.
    3. Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting.
    4. Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting.
    5. History of persistent Grade 2 or higher (National Cancer Institute [NCI]-Common Toxicity Criteria [CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy.
    6. Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
    7. Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, Version 4.0).
    8. History of other malignancy within the last 5 years prior to 1st study drug administration (dosing), except for carcinoma in situ of the cervix or basal cell carcinoma.
    9. Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for treatment-related complications.
    10. Inadequate organ function, evidenced by the following laboratory results:
    ?Absolute neutrophil count <1,500 cells/mm3
    ?Platelet count <100,000 cells/mm3
    ?Hemoglobin <9 g/dL
    ?Total bilirubin greater than the upper limit of normal (ULN; unless the patient has documented Gilbert?s syndrome)
    ?Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 × ULN (> 5 × ULN in patients with liver metastases)
    ?Alkaline phosphatase levels > 2.5 × the ULN (> 5 × ULN in patients with liver metastases, or >10 × ULN in patients with bone metastases)
    ?Serum creatinine >2.0 mg/dL or 177 ?mol/L
    ?International normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) >1.5 × ULN (unless on therapeutic anti-coagulation).
    11. Uncontrolled hypertension (systolic >150 m m Hg and/or
    diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher, or serious cardiac arrhythmia requiring medication.
    12. Current known infection with HIV, Hepatitis B virus, or Hepatitis C virus.
    13. Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy.
    14. Major surgical procedure or significant traumatic injury within 28 days prior to 1st study drug administration (dosing) or anticipation of need for major surgery during the course of study treatment.
    15. Receipt of intravenous antibiotics for infection within 14 days prior to enrolment.
    16. Current chronic daily treatment with corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids.
    17. Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.
    18. History of receiving any investigational treatment within 28 days prior to 1st study drug administration (dosing).
    19. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
    20. Concurrent participation in any interventional clinical trial.
    1.Administración previa de terapia anticancerosa no hormonal sistémica para la enfermedad metastásica o localmente recurrente.
    2.Intervalo libre de enfermedad de 6 meses desde la terminación del tratamiento no hormonal sistémico adyuvante o no adyuvante hasta la recurrencia.
    3.Administración previa de agentes anti-HER2 aprobados o en investigación, en cualquier entorno del tratamiento del cáncer de mama, exceptuando trastuzumab y/o lapatinib utilizados en el entorno neoadyuvante o adyuvante.
    4.Progresión de la enfermedad durante el tratamiento con trastuzumab y/o lapatinib en el entorno adyuvante o neoadyuvante.
    5.Antecedentes de toxicidad hematológica de grado ?2 (de acuerdo con los Criterios de Toxicidad Común [CTC] del National Cancer Institute [NCI], Versión 4.0) persistente, a consecuencia del tratamiento previo adyuvante o neoadyuvante.
    6.Evidencia radiográfica de metástasis del sistema nervioso central (SNC) en la evaluación con tomografía computerizada (TAC) o resonancia magnética (RM).
    7.Neuropatía periférica de grado ?3 (NCI-CTC, Versión 4.0) en la actualidad.
    8.Antecedentes de otras neoplasias en los 5 años previos a la administración de la primera dosis del fármaco del estudio (tratamiento), exceptuando carcinoma in situ de cérvix o carcinoma basocelular.
    9.Enfermedad concomitante grave, no controlada, para la cual estaría contraindicado el uso de cualquiera de los fármacos en investigación utilizados en este estudio o que implicaría para el paciente un riesgo alto de complicaciones relacionadas con el tratamiento.
    10.Función de órganos inadecuada, evidenciada por los resultados de laboratorio siguientes:
    ?Recuento absoluto de neutrófilos <1500 células/mm3.
    ?Recuento de plaquetas <100.000 células/mm3.
    ?Hemoglobina <9 g/dl.
    ?Bilirrubina total por encima del límite superior de normalidad (LSN) (a menos que el paciente presente síndrome de Gilbert documentado).
    ?AST (SGOT) o ALT (SGPT) >2,5 × LSN (> 5 × LSN en pacientes con metástasis hepáticas).
    ?Concentraciones de fosfatasa alcalina > 2,5 × LSN (> 5 ×LSN en pacientes con metástasis hepáticas o >10 × LSN en pacientes con metástasis óseas).
    ?Creatinina sérica >2,0 mg/dl o 177 ?mol/l.
    ?Índice internacional normalizado (INR) y tiempo de tromboplastina parcial activada (aPTT) o tiempo de tromboplastina parcial (PTT) >1,5 × LSN (a menos que el paciente esté recibiendo tratamiento anticoagulante).
    11.Hipertensión no controlada (sistólica >150 mm Hg y/o diastólica >100 mm Hg) o enfermedad cardiovascular clínicamente significativa (es decir, activa): accidente cerebrovascular/ictus o infarto de miocardio en los 6 meses previos a la administración de la primera dosis de la medicación del estudio, angina de pecho inestable, insuficiencia cardíaca congestiva (ICC) de grado > II de la New York Heart Association (NYHA) o arritmias cardíacas graves que requieran medicación.
    12.Infección confirmada por VIH, virus de la hepatitis B o virus de la hepatitis C en la actualidad.
    13.Disnea en reposo debida a complicaciones de la enfermedad neoplásica avanzada u otras enfermedades que requieran oxigenoterapia continua.
    14.Pacientes sometidos a procedimientos de cirugía mayor o que hayan sufrido traumatismos significativos en los 28 días previos a la administración de la primera dosis del fármaco del estudio (tratamiento) o que previsiblemente deban someterse a un procedimiento de cirugía mayor en el transcurso del tratamiento del estudio.
    15.Administración de antibióticos intravenosos para el tratamiento de infecciones en los 14 días previos a la inclusión en el estudio.
    16.Tratamiento crónico diario con corticosteroides en la actualidad (con una dosis equivalente a ? 10 mg/día de metilprednisolona), exceptuando esteroides administrados por vía inhalatoria.
    17.Hipersensibilidad confirmada a cualquiera de las medicaciones del estudio o a los excipientes de los anticuerpos recombinantes humanos o humanizados.
    18.Tratamiento con cualquier fármaco en investigación en los 28 días previos a la administración de la primera dosis del fármaco del estudio (tratamiento).
    19.Pacientes que, en opinión del investigador, sean incapaces o no estén dispuestos a cumplir los requisitos del protocolo.
    20.Participación simultánea en cualquier ensayo clínico intervencionista.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of safety and tolerability
    Evaluar la seguridad y tolerancia
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all patients have been followed up for at least 12 months after the last patient receives last study treatment (defined as pertuzumab, trastuzumab and a taxane), unless they have been lost to follow up, withdrawn consent, or died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.
    In addition to final analysis, there will be three interim analyses for safety reporting and publication of safety and efficacy results, approximately after: 350, 700 and 1000 patients.
    El estudio terminará cuando se haya realizado un seguimiento de todos los pacientes, como mínimo, hasta 12 meses después de que el último paciente haya recibido el último tratamiento del estudio (que se define como pertuzumab, trastuzumab o un taxano), a menos que se pierda el seguimiento de los pacientes o que éstos retiren su consentimiento o fallezcan o que el promotor decida terminar prematuramente el estudio, dependiendo de lo que ocurra antes.Además del análisis final, se realizarán tres análisis intermedios para la notificación de la seguridad y la publicación de los resultados de eficacia y seguridad, después de que se hayan incluido aproximadamente 350, 700 y 1000 pacientes en el estudio.
    E.5.2Secondary end point(s)
    Analysis of efficacy
    Análisis de la eficacia
    E.5.2.1Timepoint(s) of evaluation of this end point
    When all patients have been followed up for at least 12 months after the last patient receives last study treatment (defined as pertuzumab, trastuzumab and a taxane), unless they have been lost to follow up, withdrawn consent, or died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.
    In addition to final analysis, there will be three interim analyses for safety reporting and publication of safety and efficacy results, approximately after: 350, 700 and 1000 patients.
    El estudio terminará cuando se haya realizado un seguimiento de todos los pacientes, como mínimo, hasta 12 meses después de que el último paciente haya recibido el último tratamiento del estudio (que se define como pertuzumab, trastuzumab o un taxano), a menos que se pierda el seguimiento de los pacientes o que éstos retiren su consentimiento o fallezcan o que el promotor decida terminar prematuramente el estudio, dependiendo de lo que ocurra antes.Además del análisis final, se realizarán tres análisis intermedios para la notificación de la seguridad y la publicación de los resultados de eficacia y seguridad, después de que se hayan incluido aproximadamente 350, 700 y 1000 pacientes en el 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 No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    Quality of life
    Calidad de vida
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned55
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA231
    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
    Algeria
    Argentina
    Brazil
    Canada
    Chile
    China
    Egypt
    European Union
    India
    Indonesia
    Israel
    Japan
    Kuwait
    Lebanon
    Mexico
    Peru
    Philippines
    Qatar
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    Turkey
    United Arab Emirates
    Uruguay
    Venezuela, Bolivarian Republic of
    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 study will end when all patients have been followed up for at least 12 months after the last patient receives last study treatment (defined as pertuzumab, trastuzumab and a taxane), unless they have been lost to follow up, withdrawn consent, or died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.
    El estudio terminará cuando se haya realizado un seguimiento de todos los pacientes, como mínimo, hasta 12 meses después de que el último paciente haya recibido el último tratamiento del estudio (que se define como pertuzumab, trastuzumab o un taxano), a menos que se pierda el seguimiento de los pacientes o que éstos retiren su consentimiento o fallezcan o que el promotor decida terminar prematuramente el estudio, dependiendo de lo que ocurra antes.
    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 months0
    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 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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state165
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1091
    F.4.2.2In the whole clinical trial 1500
    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)
    After discontinuation from the study patients will return to standard care.
    Después de la participación en el estudio, los pacientes volveran a recibir el tratamiento habitual.
    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 Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-20
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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