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    Summary
    EudraCT Number:2012-000738-21
    Sponsor's Protocol Code Number:CBKM120F2203
    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:2013-06-26
    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 number2012-000738-21
    A.3Full title of the trial
    "NeoPHOEBE: Pi3k inhibition in Her2 OverExpressing Breast cancEr A phase II, randomized, parallel cohort, two stage, double-blind, placebo-controlled study of neoadjuvant trastuzumab versus trastuzumab + BKM120 in combination with weekly paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer"
    "NeoPHOEBE: inhibición de Pi3k en cáncer de mama con sobreexpresión de Her2: estudio de fase II, aleatorizado, de cohortes paralelas, de dos etapas, doble ciego y controlado por placebo de trastuzumab neoadyuvante frente a trastuzumab + BKM120 en combinación con paclitaxel semanal en cáncer primario de mama HER2 positivo con y sin mutaciones en PIK3CA"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the addition of the tested drug (BKM120) to standard therapy (trastuzumab and paclitaxel) in the treatment of type HER2 positive early breast cancer before the surgery
    Estudio para evaluar la incorporación de BKM120 al tratamiento habitual (trastuzumab y paclitaxel) para el cancer de mama inicial tipo HER2 positivo antes de la cirugia.
    A.3.2Name or abbreviated title of the trial where available
    NeoPHOEBE
    A.4.1Sponsor's protocol code numberCBKM120F2203
    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 SponsorNovartis Farmaceutica SA
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933064464
    B.5.5Fax number0034933064290
    B.5.6E-maileecc.novartis@novartis.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 nameBKM120
    D.3.2Product code BKM120
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBuparlisib
    D.3.9.2Current sponsor codeBKM120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 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 nameBKM120
    D.3.2Product code BKM120
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBuparlisib
    D.3.9.2Current sponsor codeBKM120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.IMP: 3
    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
    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 nameHerceptin
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.4EV 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 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
    D.IMP: 4
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HER2-positive, newly diagnosed, primary breast
    cancer
    Cáncer de mama primario HER2 positivo recientemente diagnosticado
    E.1.1.1Medical condition in easily understood language
    A type of early breast cancer called "HER2 -positive", so called because of the presence of a marker on the breast cancer cells called HER2
    Un tipo de cancer de mama inicial llamado "HER2-positivo" debido a la presencia de un marcador en las células del cáncer de mama llamado HER2.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    To evaluate the pathological complete response (pCR) rate irrespective of lymph node involvement, at the time of surgery in patients with HER2- overexpressing or amplified operable breast cancer randomized to neoadjuvant trastuzumab plus BKM120 (followed by trastuzumab plus BKM120 placebo plus paclitaxel) OR trastuzumab plus BKM120 (followed by trastuzumab plus BKM120 plus paclitaxel) separately for PIK3CA mutant and wild-type cohorts
    Evaluar la tasa de respuesta patológica completa (RPC) (definida en base a criterios NSABP - ausencia de enfermedad invasiva en la mama [ypT0]) independientemente de afectación ganglionar durante la cirugía en pacientes con cáncer de mama operable con sobreexpresión o amplificación de HER2 aleatorizadas a trastuzumab neoadyuvante más BKM120 placebo (seguido de trastuzumab más BKM120 placebo más paclitaxel) O BIEN trastuzumab más BKM120 (seguido de trastuzumab más BKM120 más paclitaxel) por separado en las cohortes con y sin mutaciones en PIK3CA.
    E.2.2Secondary objectives of the trial
    To compare the objective (complete + partial) response rate by ultrasound or MRI at the end of the biological window (after week 6) between the two treatments arms separately for PIK3CA mutant and wild-type cohorts
    Comparar la tasa de respuesta objetiva (completa + parcial) por ecografía o RMN al final de la ventana de actividad biológica (al final de la semana 6) entre los dos grupos de tratamiento y por separado en las cohortes con y sin mutaciones en PIK3CA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is a female ? 18 years of age
    - Patient has an ECOG performance status of 0-1
    - Patient has a unilateral (multifocal or multicentric disease allowed), histologically
    confirmed, newly diagnosed early breast cancer>2cm by clinical examination and confirmed by ultrasound or by MRI
    - Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status
    - Patient has adequate bone marrow, renal and liver function
    - Patient is able to swallow and retain oral medication
    -La paciente es una mujer de ? 18 años de edad el día de su
    consentimiento a participar en el estudio.
    -La paciente tiene un estado funcional según el Grupo Oncológico
    Cooperativo del Este (ECOG) de 0-1.
    -La paciente tiene un cáncer de mama precoz unilateral (se permite
    enfermedad multifocal o multicéntrica) recién diagnosticado y
    confirmado histológicamente >2cm (no inflamatorio) por exploración
    clínica y confirmado por ecografía o RMN.
    -La paciente dispone de tejido tumoral (biopsia con aguja gruesa) para
    revisión central de RE, HER2; PIK3CA.
    -La paciente tiene una médula ósea y función orgánica adecuadas.
    -La paciente es capaz de tragar y retener la medicación oral.
    E.4Principal exclusion criteria
    - Patient has received previous treatment with PI3K inhibitors
    - Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
    - Patient has bilateral breast cancer or metastatic
    disease or inflammatory breast cancer
    - LVEF below 55% as determined by MUGA scan or ECHO
    - Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
    - Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
    - Patient is currently receiving warfarin or other
    coumarin derived anti-coagulants
    - Patient is currently receiving increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
    - Patient is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of CYP3A
    - Patient has certain scores on an anxiety and depression mood questionnaires
    - Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
    -La paciente ha recibido tratamiento previo con inhibidores de PI3K.
    -La paciente tiene una contraindicación al uso de trastuzumab, paclitaxel
    o pre-tratamiento estándar a paclitaxel con esteroides (ver Apartado
    Medicación concomitante).
    -La paciente tiene cáncer de mama bilateral, enfermedad metastásica o
    cáncer de mama inflamatorio.
    -Fracción de eyección ventricular izquierda (FEVI) por debajo del 55%
    medida por ventriculografía isotópica (MUGA) o ecocardiograma (ECO).
    -La paciente padece una cardiopatía activa o tiene antecedentes de
    disfunción cardiaca definidas en el protocolo.
    -La paciente presenta empeoramiento de la función gastrointestinal (GI)
    o enfermedad GI que puede alterar significativamente la absorción de
    BKM120.
    -La paciente está recibiendo actualmente warfarina u otro
    anticoagulante de tipo cumarínico para tratamiento, profilaxis, etc. Se
    permite terapia con heparina, heparina de bajo peso molecular (HBPM) o
    fondaparinux.
    -La paciente está recibiendo actualmente tratamiento incrementado o
    crónico (> 5 días) con corticosteroides u otro inmunosupresor.
    -La paciente está recibiendo actualmente tratamiento con fármacos
    inhibidores o inductores moderados o potentes de la isoenzima CYP3A.
    -El paciente tiene ciertos puntajes en el cuestionario de ansiedad y
    depresión del estado de ánimo.
    -Mujeres embarazadas o lactantes, pacientes que no utiliza un método
    anticonceptivo altamente eficaz como se define en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Pathological complete response (pCR) rate
    La variable principal de evaluación de ambas cohortes con y sin mutaciones en PIK3CA es la tasa RPC
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 18
    semana 18
    E.5.2Secondary end point(s)
    - Overall objective clinical response rate at the end of the biologic window and prior to surgery
    - Efficacy by other CR definitions
    - pCR and clinical rsponse by hormone receptor status (Estrogene Receptor (ER)+ versus ER-)
    - Number of patients with node-negative disease at definitive surgery (ypN0)
    - Rate of breast conserving surgery
    - Safety and tolerability
    Tasa de respuesta clínica objetiva global (completa + parcial) medida por ecografía bidimensional o por RMN, valorada por criterios de la OMS al final de la semana 6 y comparada con el nivel basal
    Otras variables secundarias RPC definida como ausencia de restos invasivos y no invasivos (CDIS) en mama y ganglios linfáticos (ypT0, pN0 [definición GBG]) RPC definida como ausencia de restos invasivos en mama y ganglios linfáticos (ypT0/Tis, ypN0 [definición MD Anderson]) Porcentaje de pacientes con restos de CDIS en mama en la cirugía definitiva independientemente de estado de ganglio linfático (ypTis, ypNx) Tasa de respuesta clínica objetiva global (completa + parcial) medida por ecografía bidimensional y valorada por criterios de la OMS antes de la cirugía RPC y respuesta clínica por estado del receptor hormonal (RE+ vs. RE-) Porcentaje de pacientes con enfermedad sin afectación ganglionar en la cirugía definitiva (ypN0) Tasa de cirugía conservadora de mama. - Acontecimientos adversos hematológicos y no hematológicos grado 1-4 y grado 3-4; retraso, interrupción, reducción o suspensión permanente del tratamiento especificando motivos. - Correlación entre las respuestas objetivas medidas por ecografía o RMN de mama y valoradas por criterios de la OMS al final de la semana 6, antes de la cirugía y por tasas de RPC por pacientes con la respuesta metabólica completa y parcial el día 15.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline for endpoints overall objective clinical trial response rate, efficacy by other pCR definitions, pCR and clinical response by hormone receptor status.
    +week 6 for the overall objective clinical response rate.
    +week 18 for all endpoints.
    En la visita basal para las variables globales de tasa de respuesta clinica objetiva, eficacia por otras definiciones de respuesta patológica completa, respuesta patológica completa y respuesta clinica por estado de receptor hormonal.

    semana 6 para la tasa global de respuesta clínica objetiva.
    semana 18 para todas las variables.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Australia
    Austria
    Belgium
    Brazil
    France
    Germany
    Italy
    New Zealand
    Peru
    Singapore
    Spain
    Switzerland
    Taiwan
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    Last Patient Last Visit
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial 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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 220
    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)
    Following completion of study treatment, surgical excision, additional adjuvant systemic therapy (either hormonal and/or chemotherapy) will be at the discretion of the investigator. Post-operative radiotherapy is suggested if breast conserving surgery has been performed and will be done as per institutional standards
    Tras la cumplimentación de tratamiento del estudio y la cirugia la terapia sistemica adjuvante posterior (hormono y/o quimioterapia) será administrada a criterio del investigador. La radioterapia post-operatoria esta indicada si se ha realizado cirugia conservadora de la mama y será administrada siguiendo la práctica clinica 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 Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-18
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