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    Summary
    EudraCT Number:2014-001458-40
    Sponsor's Protocol Code Number:BO29159
    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:2015-01-26
    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 number2014-001458-40
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, SINGLE-ARM SAFETY STUDY OF HERCEPTIN® SC IN COMBINATION WITH PERJETA® AND DOCETAXEL IN TREATMENT OF PATIENTS WITH HER2?POSITIVE ADVANCED BREAST CANCER (METASTATIC OR LOCALLY RECURRENT)
    Estudio multicéntrico, abierto, de un solo brazo de estudio de seguridad de Herceptin® en combinación con Perjeta® y docetaxel en el tratamiento de pacientes con cáncer de mama avanzado HER2 positivo (metastásico o localmente recurrente)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC with Perjeta and Docetaxel in Patients with HER2-positive Advanced Breast Cancer
    Estudio multicéntrico para evaluar la seguridad y tolerancia de Herceptin SC con Perjeta y Docetaxel en pacientes con cáncer de mama avanzado HER2 positivo.
    A.3.2Name or abbreviated title of the trial where available
    MetaPHer
    MetaPHer
    A.4.1Sponsor's protocol code numberBO29159
    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 SponsorRoche Farma, S.A. en nombre de F. 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 AddressGrenzacherstrassen 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+3491325 73 00
    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 Yes
    D.2.1.1.1Trade name Herceptin 600 mg/5 mL solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, U.K.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code Ro 045-2317/F07
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.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 Perjeta
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 436-8451/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 namePERTUZUMAB
    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
    HER2?POSITIVE METASTATIC OR LOCALLY RECURRENT ADVANCED BREAST CANCER
    Cáncer de mama avanzado HER2 positivo (metastásico o localmente recurrente)
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cáncer 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 18.0
    E.1.2Level PT
    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
    The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2?positive advanced (metastatic or locally recurrent) breast cancer.
    ? Overall safety profile as determined by adverse events of any grade of severity, and adverse events Grade ? 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 and cardiac function will be assessed including the following: cardiac events Grade ? 3, congestive heart failure (CHF), and cardiac death
    El objetivo principal de este estudio es evaluar la seguridad y la tolerabilidad de Herceptin s.c. en combinación con Perjeta i.v. más docetaxel en pacientes con cáncer de mama avanzado (metastásico o recidivante localmente) positivo para HER-2.
    - Se evaluarán el perfil global de seguridad, determinado por los acontecimientos adversos de cualquier grado de intensidad, y los acontecimientos adversos de grado ? 3 conforme a los criterios terminológicos comunes para los acontecimientos adversos del National Cancer Institute (CTCAE del NCI), versión 4.0, y la función cardíaca, incluidos los siguientes: acontecimientos
    cardíacos de grado ? 3, insuficiencia cardíaca congestiva (ICC), y muerte por causas cardíacas (véase la Sección 6.5)
    E.2.2Secondary objectives of the trial
    The secondary objectives for this study are to evaluate Herceptin SC in combination with Perjeta IV plus docetaxel with respect to:
    ? Efficacy parameters
    PFS
    OS
    Objective Response Rate (ORR)
    ? Incidence of anti-Herceptin and anti-rHuPH20 antibody formation
    El objetivo secundario de este estudio es evaluar Herceptin s.c. en combinación con Perjeta i.v. más docetaxel con respecto a:
    - Parámetros de la eficacia (véase la Sección 6.4)
    SSP
    SG
    Tasa de respuesta objetiva (TRO)
    - Incidencia de formación de anticuerpos frenta a Herceptin y frente a rHuPH20
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection. Patients with measurable and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 are eligible.
    - HER2-positive disease (defined as either immunohistochemistry [IHC] 3 + or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor or metastatic site if primary tumor not available
    - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
    - Left ventricular ejection fraction (LVEF) of at least 50%
    - Negative serum pregnancy test result at baseline and use of effective contraception as defined by the protocol
    - Adenocarcinoma de mama confirmado y documentado mediante histología o citología con metástasis o recidiva local no susceptible de resección curativa. Son elegibles las pacientes con tumor medible o no medible evaluable conforme a los
    criterios RECIST v1.1 (véase el Apéndice 5).
    - Enfermedad positiva para HER2 (definida como resultado positivo mediante IHQ 3 o ISH), determinada por el laboratorio local en el tumor primario o la zona de la metástasis si no se dispone del tumor primario
    - Estado funcional del Grupo Oncológico Cooperativo de la Costa Este (ECOG) de 0 o 1 (véase el Apéndice 3).
    - FEVI de al menos el 50 %.
    - Resultado negativo en una prueba de embarazo y uso d un método anticonceptivo no hormonal de gran eficacia definido por protocolo.
    E.4Principal exclusion criteria
    Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease. Note: Prior to study entry, up to two lines of hormonal therapy for metastatic or locally recurrent disease are permitted, one of which may be in combination with everolimus.
    - Disease-free interval of at least 6 months from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of breast cancer
    - Previous approved or investigative anti-HER2 agents as neoadjuvant or adjuvant therapy for any breast cancer treatment, except Herceptin
    - History of persistent Grade 2 or higher hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
    - Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
    - Current peripheral neuropathy of Grade 3 or greater
    - History of other malignancy within the last 5 years prior to first dose of study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
    - Inadequate organ function
    - Uncontrolled hypertension with or without medication
    - Clinically significant cardiovascular disease
    - History of LVEF decline to below 50% during or after prior Herceptin neo-adjuvant or adjuvant therapy
    - Current known infection with HIV, hepatitis B virus, or hepatitis C virus
    - Severe 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, including severe pulmonary conditions/illness
    - Pregnant or lactating women
    - Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy
    - History of receiving any investigational treatment within 28 days prior to first dose of study drug administration (dosing) or concurrent participation in any interventional clinical trial
    Tratamiento antineoplásico sistémico no hormonal previo para la enfermedad metastásica o recidivante localmente. Nota: Antes de la entrada en el estudio, se permiten hasta dos líneas de tratamiento hormonal para la enfermedad metastásica o recidivante localmente, una de las cuales puede ser en combinación con everolimús.
    -Intervalo sin enfermedad de al menos 6 meses desde la finalización del tratamiento sistémico no hormonal prequirúrgico o posquirúrgico hasta la recidiva del cáncer de mama.
    -Administración previa de fármacos anti HER2 aprobados o en investigación como tratamiento prequirúrgico o posquirúrgico para cualquier cáncer de mama, salvo Herceptin.
    -Antecedentes de toxicidad hemática persistente de grado 2 o superior derivada de un tratamiento prequirúrgico o posquirúrgico previo.
    -Pacientes con indicios radiográficos de metástasis en el SNC, evaluadas mediante tomografía computarizada o resonancia magnética (RM) si han sido tratadas y permanecido estables en los 3 meses anteriores a la selección y no requieren control con un tratamiento continuo con corticoesteroides.
    -Neuropatía periférica actual de grado 3 o superior.
    -Antecedentes de otra neoplasia maligna en los 5 años anteriores a la administración de la primera dosis del fármaco del estudio, a excepción de carcinoma de cuello de útero localizado o carcinoma basocelular.
    -Función orgánica inadecuada
    -Hipertensión no controlada con o sin medicación
    -Cardiovasculopatía clínicamente significativa
    -Antecedentes de disminución de la FEVI a menos del 50 % durante o después de un tratamiento prequirúrgico o posquirúrgico previo con Herceptin.
    -Infección actual conocida por el VIH, el virus de la hepatitis B o el virus de la hepatitis C.
    -Enfermedad concomitante grave no controlada que contraindicaría el uso de cualquiera de los fármacos en investigación empleados en este estudio o que pondría a la paciente en un mayor riesgo de sufrir complicaciones relacionadas con el tratamiento, como enfermedad sistémica no controlada (p. ej., neumopatía), o enfermedad metabólica, trastornos de la cicatrización de heridas, úlceras o fracturas óseas.
    -Mujeres embarazadas o en periodo de lactancia.
    -Disnea en reposo debido a complicaciones de una neoplasia maligna avanzada u otra enfermedad que requiera terapia continua con oxígeno.
    -Antecedentes de cualquier tratamiento en investigación en los 28 días anteriores a la administración de la primera dosis del fármaco del estudio o participación concurrente en un ensayo clínico intervencionista.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence and severity of adverse events Grade >/= 3, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0
    - Incidence of cardiac events (composite outcome measure): congestive heart failure (CHF) and cardiac death
    - Incidence of adverse events (AEs)
    - Incidencia e intensidad de los acontecimientos adversos de grado >/= 3 según los criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute, Versión 4.0
    - Incidencia de insuficiencia cardíaca y muerte por causas cardíacas
    - Incidencia e intensidad de todos los acontecimientos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Timeframe: Up to 24 months after the last patient has been enrolled, approximately 3.5 years
    - Timeframe: Up to 24 months after the last patient has been enrolled, approximately 3.5 years
    - Timeframe: Up to 24 months after the last patient has been enrolled, approximately 3.5 years
    - Periodo de tiempo: hasta 24 meses después de la inclusión de la última paciente, aproximadamente 3,5 años
    - Periodo de tiempo: hasta 24 meses después de la inclusión de la última paciente, aproximadamente 3,5 años
    - Periodo de tiempo: hasta 24 meses después de la inclusión de la última paciente, aproximadamente 3,5 años
    - Periodo de tiempo: hasta 24 meses después de la inclusión de la última paciente, aproximadamente 3,5 años
    E.5.2Secondary end point(s)
    - Progression-free survival, tumor assessments according to RECIST v1.1
    - Overall survival
    - Objective response rate, defined as a complete response (CR) or a partial response (PR)
    - Outcome Measure: Incidence of anti-Herceptin, anti-rHuPH20 antibodies
    - Supervivencia Sin Progresión según determine el investigador usando los actuales Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1
    - Supervivencia Global
    - Tasa de Respuesta Objetiva definida como como una remisión completa (RC) o una remisión parcial (RP)
    - Resultado medido: incidencia de anticuerpos frente a Herceptin y frente a rHuPH20
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Timeframe: Up to 3.5 years
    - Timeframe: Up to 3.5 years
    - Timeframe: Up to 3.5 years
    - Timeframe: Up to 3.5 years
    - Periodo de tiempo: hasta 3,5 años
    - Periodo de tiempo: hasta 3,5 años
    - Periodo de tiempo: hasta 3,5 años
    - Periodo de tiempo: hasta 3,5 años
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - tolerability of Herceptin subcutaneous (SC) in combination with Perjeta intravenous (IV) plus docetaxel
    - Incidence of anti-Herceptin and anti-rHuPH20 antibody formation
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    safety and tolerability of Herceptin SC in comb. with Perjeta/docetaxel
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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
    study will end at the time of the cutoff for final analysis, 24 months after last patient has been enrolled, or all patients in study have withdrawn consent, died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.
    patients still receiving study treatment at time of cutoff will have their post-treatment safety follow-up visit 28?35 days after the last dose of study treatment, and then will be considered as finished with their participation in the study
    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 months6
    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 months6
    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: 336
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    Patients will continue to be followed in accordance with the local standard of care.
    These patients may be provided with commercial drug for continuation of treatment. This will depend on the local availability of commercial Herceptin and Perjeta.
    The Sponsor will offer post-trial access to the study drug Herceptin and Perjeta free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, see section 4.3.4 of protocol.
    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 Decision2015-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-22
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