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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2014-000156-28
    Sponsor's Protocol Code Number:WO29217
    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:2014-04-25
    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 number2014-000156-28
    A.3Full title of the trial
    A MULTICENTER, MULTINATIONAL, PHASE II STUDY TO EVALUATE PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND STANDARD NEOADJUVANT ANTHRACYCLINE-BASED CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE, LOCALLY ADVANCED, INFLAMMATORY, OR EARLY-STAGE BREAST CANCER
    ESTUDIO DE FASE II MULTICÉNTRICO, MULTINACIONAL, DE EVALUACIÓN DE PERTUZUMAB EN COMBINACIÓN CON TRASTUZUMAB Y QUIMIOTERAPIA NEOADYUVANTE BASADA EN ANTRACICLINAS EN PACIENTES CON CÁNCER DE MAMA HER2 POSITIVO LOCALMENTE AVANZADO, INFLAMATORIO O PRECOZ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy as Neoadjuvant Therapy in Patients With HER2-Positive Early Breast Cancer
    Estudio de Perjeta (Pertuzumab) en combinación con Herceptin (Trastuzumab) y quimioterapia como neoadyuvante en pacientes con cáncer de mama HER2 positivo precoz
    A.3.2Name or abbreviated title of the trial where available
    BERENICE
    BERENICE
    A.4.1Sponsor's protocol code numberWO29217
    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+34 913257300
    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 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 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.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 Herceptin
    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 nameTrastuzumab
    D.3.2Product code Ro 045-2317/V03
    D.3.4Pharmaceutical form Powder for 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRo 045-2317
    D.3.9.3Other descriptive namerhuMAb HER2
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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, LOCALLY ADVANCED, INFLAMMATORY, OR EARLY-STAGE BREAST CANCER
    CÁNCER DE MAMA HER2 POSITIVO LOCALMENTE AVANZADO, INFLAMATORIO O PRECOZ
    E.1.1.1Medical condition in easily understood language
    early breast cancer
    Cáncer de mama precoz
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term 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 of this study is to evaluate the cardiac safety of neoadjuvant treatment with the following regimens:
    - ddAC-->T+ PH: Dose-dense doxorubicin and cyclophosphamide (ddAC) given every 2 weeks for four cycles with granulocyte colony-stimulating factor (G-CSF) support as needed according to local guidelines, followed by weekly paclitaxel (T) for 12 weeks, with pertuzumab and trastuzumab (PH) given every 3 weeks from the start of paclitaxel (Cohort A).
    - FEC-->D+ PH: 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) given every 3 weeks for four cycles, followed by docetaxel (D) given every 3 weeks for four cycles, with pertuzumab and trastuzumab (PH) given every 3 weeks from the start of docetaxel (Cohort B).
    El objetivo principal de este estudio es evaluar la seguridad cardiaca del tratamiento neoadyuvante con los siguientes regímenes:
    - ACdd-->T + PH: doxorubicina y ciclofosfamida a dosis densas (ACdd) administradas cada 2 semanas durante cuatro ciclos con tratamiento de soporte con factor estimulante de colonias de granulocitos (G-CSF) según se requiera de acuerdo con las directrices locales, seguidas de paclitaxel (T) semanal durante 12 semanas, con pertuzumab y trastuzumab (PH) administrados cada 3 semanas desde el comienzo del paclitaxel (cohorte A).
    - FEC -->D + PH: 5-fluorouracilo, epirubicina y ciclofosfamida (FEC) administrados cada 3 semanas durante cuatro ciclos, seguidos de docetaxel (D) administrado cada 3 semanas durante cuatro ciclos, con pertuzumab y trastuzumab (PH) administrados cada 3 semanas desde el comienzo del docetaxel (cohorte B).
    E.2.2Secondary objectives of the trial
    - Secondary safety objectives are to evaluate the safety profiles of the two treatment regimens during the pre-operative (neoadjuvant) and adjuvant treatment periods, including adverse events (graded according to NCI CTCAE Version 4.0), serious adverse events, laboratory abnormalities (graded according to NCI CTCAE Version 4.0), and serum levels of anti-therapeutic antibodies (ATAs) against pertuzumab.
    - The efficacy objectives for this study are as follows:
    - To make an assessment of the antitumor activity associated with each regimen, as indicated by the pCR rate (defined as eradication of invasive disease in the breast and axilla; i.e., ypT0/is ypN0, or tpCR rate)
    - To investigate the clinical response, event-free survival (EFS), invasive disease-free survival (iDFS), and overall survival (OS) for each treatment regimen
    Los objetivos de seguridad secundarios comprenden la evaluación de los perfiles de seguridad de los dos regímenes de tratamiento durante los periodos de tratamiento preoperatorio (neoadyuvante) y adyuvante, incluyendo acontecimientos adversos (clasificados de acuerdo a los CTCAE-NCI versión 4.0), acontecimientos adversos graves, alteraciones analíticas (clasificadas de acuerdo a los CTCAE-NCI versión 4.0) y concentraciones séricas de anticuerpos antiterapéuticos (AAT) frente a pertuzumab.
    Los objetivos de eficacia de este estudio son los siguientes:
    - Evaluar la actividad antitumoral asociada a cada régimen de acuerdo a la tasa de RCp (definida como la erradicación de la enfermedad invasiva en mama y axila; es decir, ypT0/is ypN0, o tasa de RCpt)
    - Estudiar la respuesta clínica, supervivencia sin acontecimientos (SSA), supervivencia sin enfermedad invasiva (SSEi) y supervivencia global (SG) para cada régimen de tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients, > o = 18 years of age
    - HER2-positive breast cancer confirmed by a central laboratory
    - Primary tumor > 2 cm in diameter, or > 5 mm in diameter and node-positive
    - Eastern Cooperative Oncology Group (ECOG) performance status < o = 1
    - Baseline LVEF > o = 55% (measured by ECHO or MUGA)
    - Edad > o = 18 años
    - Cáncer de mama HER2 positivo confirmado las en un laboratorio central
    - Tumor primario con diámetro > 2 cm o, diámetro > 5 mm y ganglios positivos
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) < o = 1
    - FEVI basal > o = 55% (determinada mediante ECO o MUGA)
    E.4Principal exclusion criteria
    - Any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
    - Metastatic disease (Stage IV) or bilateral breast cancer
    - Previous exposure to any investigational treatment within 4 weeks before the first dose of study treatment
    - History of non-breast malignancies within 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the
    skin.
    - Inadequate hematologic, renal or liver function
    - Pregnant or lactating women
    - History of congestive heart failure of any New York Heart Association (NYHA) criteria
    - angina requiring anti-anginal medication
    - history of myocardial infarction within 6 months of enrollment
    - serious or uncontrolled cardiac arrhythmia requiring treatment
    - History or evidence of poorly controlled hypertension
    - Severe, uncontrolled systemic disease
    - Positive for hepatitis B, hepatitis C or HIV infection
    - Cualquier terapia sistémica previa para el cáncer (incluida quimioterapia, inmunoterapia, agentes dirigidos a HER2 y vacunas antitumorales) o radioterapia para el cáncer
    - Enfermedad metastásica (estadio IV) o cáncer de mama bilateral
    - Pacientes que hayan recibido algún tratamiento en investigación en las 4 semanas previas a la primera dosis del estudio
    - Antecedentes de neoplasias malignas que no sean de mama en los 5 años previos a la incorporación en el estudio, excepto carcinoma in situ de cuello uterino, carcinoma in situ de colon, melanoma in situ y
    carcinoma cutáneo basocelular y de células escamosas.
    - Deterioro de la función hematológica, renal o hepática
    - Mujeres embarazadas o en periodo de lactancia
    - Antecedentes de Insuficiencia Cardiaca Congestiva de cualquier grado en la clasificación NYHA (New York Heart Association)
    - Angina que requiere medicación antianginosa
    - Antecedentes de infarto de miocardio en los 6 meses previos a inclusión
    - Arritmia cardiaca grave o no controlada que requiere tratamiento
    - Antecedentes de evidencia de hipertensión mal controlada
    - Enfermedad sistémica grave, no controlada
    - Pacientes con infección conocida por VIH, virus de la hepatitis B o virus de la hepatitis C
    E.5 End points
    E.5.1Primary end point(s)
    Cardiac safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic).
    Seguridad cardiaca: Incidencia de disfunción sistólica ventricular izquierda (sintomática o asintomática)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary cardiac safety evaluation will occur after all patients have completed neoadjuvant therapy (or have withdrawn from the study or are lost to follow up).
    Cardiac safety will continue to be assessed in all patients throughout the adjuvant and post-treatment period. Additional analyses of these parameters (and other safety and efficacy data) will be conducted after the primary analysis at the following timepoints:
    - After all patients have completed adjuvant anti-HER2 therapy (or have withdrawn from the study or are lost to follow up)
    - At the end of the study (5 years after the last patient was enrolled)
    La evaluación principal de la seguridad cardiaca tendrá lugar cuando todos los pacientes hayan completado el tratamiento neoadyuvante (o se hayan retirado del estudio o se haya perdido su seguimiento).
    La seguridad cardiaca seguirá evaluándose en todos los pacientes en el transcurso del periodo de tratamiento adyuvante y del periodo posterior al tratamiento. Se realizarán análisis adicionales de estos parámetros (y de otros datos de seguridad y eficacia) después del análisis principal, en los momentos siguientes:
    - Después de que todos los pacientes hayan completado el tratamiento adyuvante anti-HER2 (o se hayan retirado del estudio o se haya perdido su seguimiento)
    - Al final del estudio (5 años después de la inclusión del último paciente)
    E.5.2Secondary end point(s)
    - To make an assessment of the antitumor activity associated with each regimen, as indicated by the pCR rate
    - To investigate the clinical response, event-free survival (EFS), invasive disease-free survival (iDFS), and overall survival (OS) for each treatment regimen
    - Safety: Incidence of adverse events
    - Evaluar la actividad antitumoral asociada a cada régimen de acuerdo a la tasa de RCp
    - Estudiar la respuesta clínica, supervivencia sin acontecimientos (SSA), supervivencia sin enfermedad invasiva (SSEi) y supervivencia global (SG) para cada régimen de tratamiento
    - Seguridad: Incidencia de los acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy will be assessed at the time of the primary analysis and at other key timepoints:
    - After all patients have completed adjuvant anti-HER2 therapy (or have withdrawn from the study or are lost to follow up)
    - At the end of the study (5 years after the last patient was enrolled)
    La eficacia se evaluará en el momento del análisis principal y en otros momentos clave:
    - Después de que todos los pacientes hayan completado el tratamiento adyuvante anti-HER2 (o se hayan retirado del estudio o se haya perdido su seguimiento)
    - Al final del estudio (5 años después de la inclusión del último paciente)
    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 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 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 trial2
    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 EEA59
    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
    Canada
    Denmark
    France
    Italy
    Norway
    Portugal
    Brazil
    Germany
    Spain
    Poland
    United Kingdom
    United States
    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 end of the study will be 5 years after enrollment of the last patient in the study (or when all patients have died or the trial is terminated by the Sponsor, whichever is earliest). This data point will be considered last patient, last visit (LPLV).
    El final del estudio tendrá lugar 5 años después de la inclusión del último paciente en el estudio (o cuando todos los pacientes hayan fallecido o el promotor dé por terminado el estudio, lo que ocurra primero). Este momento se considerará la última visita del último paciente (UVUP).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 367
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    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)
    Currently, the sponsor does not have any plans to provide pertuzumab or trastuzumab or other study interventions to patients after the conclusion of the study or any earlier withdrawal.Patients who complete or withdraw from the study will be moved to appropriate treatment for breast cancer as determined by their doctor.
    Actualmente, el promotor no tiene intención de suministrar pertuzumab o trastuzumab u otro de los tratamientos del estudio a los pacientes después de la conclusión del estudio o abandono prematuro de algún paciente. Los pacientes que completen o abandonen el estudio serán transferidos para recibir el tratamiento adecuado para el cancer de mama según determine su médico.
    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 Decision2014-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-25
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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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