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    Summary
    EudraCT Number:2011-006326-24
    Sponsor's Protocol Code Number:D699BC00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-25
    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 number2011-006326-24
    A.3Full title of the trial
    A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated Wuith Any Hormonal Therapy
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y de grupos paralelos para comparar la eficacia y la tolerabilidad de fulvestrant (FASLODEXTM) 500 mg con anastrozol (ARIMIDEXTM) 1 mg como tratamiento hormonal de las mujeres posmenopáusicas con cáncer de mama localmente avanzado o metastásico con receptores hormonales positivos que no han sido tratadas previamente con hormonoterapia (FALCON)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global study to compare the effects of fulvestrant and arimidex in a subset of patients with breast cancer
    Un estudio global para comparar los efectos de fulvestrant y arimidex en un subconjunto de pacientes con cáncer de mama
    A.3.2Name or abbreviated title of the trial where available
    FALCON
    A.4.1Sponsor's protocol code numberD699BC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@astrazeneca.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 Faslodex 250 mg solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameFaslodex 250 mg solution for injection
    D.3.2Product code ZD9238
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFULVESTRANT
    D.3.9.1CAS number 129453-61-8
    D.3.9.2Current sponsor codeZD9238
    D.3.9.3Other descriptive nameICI 182780
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Arimidex 1 mg film coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameArimidex 1 mg film coated tablet
    D.3.2Product code ZD1033
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNanastrozole
    D.3.9.1CAS number 120511-73-1
    D.3.9.2Current sponsor codeZD1033
    D.3.9.3Other descriptive nameANASTROZOLE
    D.3.9.4EV Substance CodeSUB05502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    hormone receptor positive breast cancer, hormone naive, breast, cancer, neoplasm breast cancer, metastatic, tumour, neoplasm
    Receptor Hormonal positivo de cancer , mama, cancer, cancer de mama neoplasico, metastastásico, tumor, neoplasico
    E.1.1.1Medical condition in easily understood language
    hormone receptor positive breast cancer, hormone naive, breast, cancer, neoplasm, metastatic, tumour
    Receptor Hormonal positivo de cancer, mama. cancer, neoplasico, estastasico, tumor
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superior progression free survival for patients treated with fulvestrant 500mg versus patients treated with anastrozole 1mg
    demostrar la SSP superior de las pacientes tratadas con fulvestrant 500 mg en comparación con las tratadas con anastrozol 1 mg
    E.2.2Secondary objectives of the trial
    To compare the overall survival, objective responses, clinical benefit responses, quality of life and safety profile for study patients
    Demostrar la supervivencia global, respuesta objetiva, respuesta clinica objetiva, calidad de vida y perfil de seguridad para las pacientes del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Histological confirmation of breast cancer in post menopausal women (age >=60)
    2 Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
    3 EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
    4 At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
    5 Postmenopausal woman, fulfilling 1 of: Prior bilateral oophorectomy/Age ?60 years/Age <60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range
    1. Confirmación histológica del cáncer de mama.
    2. Receptores hormonales positivos (RE+, RPg+ o ambos) en tejido tumoral primario o metastásico, según la evaluación del laboratorio local.
    3. Presencia de:
    - Enfermedad localmente avanzada que no se preste a cirugía o radioterapia con intención curativa. Las pacientes pueden haber recibido una línea de quimioterapia citotóxica, tras de la cual deben seguir sin ser aptas para recibir tratamiento con intención curativa.
    O BIEN
    - Enfermedad metastásica.
    Las pacientes podrán haber recibido una línea de quimioterapia citotóxica como tratamiento previo del cáncer de mama, pero deben presentar progresión de la enfermedad antes de la inclusión.
    4. Al menos una lesión que pueda evaluarse con exactitud en el momento basal y sea adecuada para ser objeto de evaluaciones.
    5. Mujer posmenopáusica, definida como la que cumpla alguno de los criterios siguientes
    - Ovariectomía bilateral previa.
    - Edad ? 60 años.
    - Edad < 60 años y amenorrea durante 12 meses o más en ausencia de quimioterapia, tamoxifeno, toremifeno o supresión ovárica y concentraciones de FSH y estradiol en intervalos posmenopáusicos.
    E.4Principal exclusion criteria
    1 Presence of life-threatening metastatic disease - Any of: Extensive hepatic involvement/ involving brain or meninges/ symptomatic pulmonary lymph spread. Discrete lung metastases are acceptable if respiratory function is not significantly compromised
    2 Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation).
    3 Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation).
    4 Prior hormonal treatment for breast cancer.
    5 Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
    1. Presencia de enfermedad visceral metastásica potencialmente mortal, definida como afectación hepática extensa, cualquier grado de afectación encefálica o leptomeníngea o diseminación linfangítica pulmonar sintomática. Podrán participar las pacientes con metástasis parenquimatosas pulmonares definidas siempre que su función respiratoria no se encuentre significativamente afectada como consecuencia de la enfermedad según el criterio del investigador.
    2. Tratamiento sistémico previo contra el cáncer de mama distinto de una línea de quimioterapia citotóxica (la última dosis de quimioterapia tendrá que haberse recibido más de 28 días antes de la aleatorización).
    3. Radioterapia, en caso de no haberse finalizado en los 28 días previos a la aleatorización (excepto la radioterapia administrada para controlar el dolor óseo, que debe haber terminado antes del día de la aleatorización).
    4. Tratamiento previo con un fármaco para el cáncer de mama.
    5. Neoplasia maligna actual o previa (distinta del cáncer de mama o de un carcinoma basocelular o espinocelular de piel o un carcinoma in situ de cuello uterino debidamente tratado), salvo que se haya tratado con intención curativa y no haya habido indicios de enfermedad durante los 3 años previos.
    E.5 End points
    E.5.1Primary end point(s)
    Compare the progression free survival (PFS) in patients treated with fulvestrant with those treated with anastrozole
    Comparar la progresion sin supervivencia en pacientes tratadas con fulvestrant con aquellas tratadas con anastrazol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease.
    Valoracion RECIST 1.1 y luego cada 12 semanas hasta la primer evidencia de progresion de la enfermedad, pacientes fallecidas o tienen cirugia/radioterapia para su enfermedad.
    E.5.2Secondary end point(s)
    1 Compare the Overall Survival (OS, death due to any cause) in patients treated with fulvestrant with those treated with anastrozole when 50% of patients are recorded as having died.
    2 Measure objective response rate (ORR) for fulvestrant treatment versus anastrozole. (ORR =% of patients recording partial (PR) or complete response (CR)
    3 Measure the duration of response (DoR) for fulvestrant treatment versus anastrozole. (DoR = days from PR/CR response to objective disease progression)
    4 Measure expected duration of response (EDoR) for fulvestrant treatment versus anastrozole. (EDoR = p Efp(x), where x=DoR, p=proportion of responders, Efp(x) is mean duration of response)
    5 Measure clinical benefit rate (CBR) for fulvestrant treatment versus anastrozole. (CBR= proportion of patients recording RECIST assessments of CR/PR or stable disease (SD) over at least 154 days
    6 Measure the duration of clinical benefit (DoCB) for fulvestrant versus anastrozole treatment. (DoCB = for patients recording clinical benefit responses only; days from randomization to date of disease progression)
    7 Measure expected duration of clinical benefit (EDoCB) for fulvestrant treatment versus anastrozole. (EDoCB = p Efp(x), where x=DoCB, p=proportion of responders, Efp(x) is mean duration of clinical benefit)
    8 Compare the effect of fulvestrant treatment versus anastrozole treatment on Health Related Quality of Life (HRQoL)
    9 Compare the safety of fulvestrant treatment versus anastrozole by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and haematology and clinical chemistry assessments
    1. Comparar la supervivencia global (SG, de muerte por cualquier causa) en pacientes tratadas con fulvestrant versus aquellas tratadas con anastrazol cuando el 50% de las pacientes estas registradas como fallecidas.
    2. Medir la tasa de respuestas objetiva (ORR) para el tratamiento con fulvestrant versus anastrazol. (ORR=% de pacientes con respuesta parcial (PR) o respuesta completa (CR))
    3. Medir la duracion de la respuesta (DoR) para el tratamiento con fulvestrant versus tratamiento con anastrazol (DoR= dias desde respuesta PR/PC a progresion objetiva de la enfermedad)
    4. Medir la duracion estimada de respuesta (EDoR) para tratamiento con fulvestrant versus anastrazol (EDoR= pEfp(x), donde p= proporcion de pacientes que responden, Efp(x) es la duracion de la respuesta.)
    5. Medir la duracion del beneficio clínico (CBR) para el tratamiento con fulvestrant versus anastrazol. (CBR= proporcion de pacientes registrados mediante valoracion RECIST de CR/PR o enfermedad estable (SD) al menos sobre 154 dias)
    6. Medir la duracion estimada del beneficio clinico (EDoCB) para tramiento de fulvestrant versus tratamiento de anastrazol. (DoCB=para pacientes registrados solo con respuesta clinica beneficiosa; dias desde randomizacion hasta fecha de proigresion de la enfermedad)
    7. Medir la duracio estimada del beneficio clinico (EDoCB) para tratamiento de fulvestrant versus anastrazol.(EDoCB=pEfp(x), donde x= DoCB, p=proporcion de pacientes que responden, Efp(x) es la duracion del beneficio clinico)
    8. Comparar el efecto del tratamiento de fulvestrant versus tratamiento de anastrazol
    9. Comparar la seguridad del tratamiento de fulvestrant versus anastrazol por valoracion de medida de eventos adversos: examen fisico, electrocardiograma, pulso y presion sanguinea, peso y valoraciones de hematologia y quimica clinica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 Following progression, patients will be contacted at 12 weekly intervals to determine survival status

    Nos 2-7 Baseline RECIST 1.1 assessments and then every 12 weeks

    8 Quality of life questionnaires completed at baseline, 12 weekly whilst on treatment, or 24 weekly for patients being followed for survival

    9 Up to the primary analysis: Adverse event will be collected from consent to 56 days after final injection. Vital signs will be collected at each on-treatment visit; ECGs, clinical chemistry and haematology collected from randomization and every 12 weeks until 35 days after final injection. Following the primary analysis, only serious adverse events are recorded.
    1 seguimiento de la progresion, pacientes seran contactadas cada 12 semanas para determinar el estado de supervivencia.
    Numeros 2-7, momento basal valoraciones RECIST 1.1 y cada 12 semanas
    8 Cuestionarios de calidad de vida completados en el momento basal, cada 12 semanas con tratamiento, o 24 semanas para pacientes que estan siendo seguidas para la supervivencia
    9. Hasta el analisis primario: eventos adversos seran recogidos desde el consentimiento hasta 56 dias despues de la ultima inyeccion. Signos viyales seran recogidos en cada visita de tratamiento; ECGs, quimica clinica y hematologia recogida desde la randomizacion y cada 12 semanas hasta 35 dias despues de la ultima inyeccion. Seguimiento de analisis primario, solo los acontecimientos graves son registrados.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Argentina
    Brazil
    Canada
    China
    Czech Republic
    India
    Italy
    Japan
    Mexico
    Peru
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Taiwan
    Turkey
    Ukraine
    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 study database will close after the last patient assessment/visit contributing to the overall survival analysis, which will be conducted when approximately 50% patients have died. The end of the study is defined as the last visit of the last patient, occurring when the last patient has discontinued study therapy
    La base de datos del estudio se cerrará despues de la ultima visita/valoracion del ultimo paciente copntribuyendo al analisis de supervivencia global, el cual se realizará cuando aproximadamente el 50% de las pacientes hayan fallecido. El final del estudio esta definido como la ultima visita del ultimo paciente, ocurrida cuando el ultimo paciente has discontinuado la terapia del estudio.
    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 months9
    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 months9
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 450
    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 receive sudy treatment beyond the closure of the database if, in the opinion of the investigator, they are continuing to receive benefit from treatment with fulvestrant or anastrozole and cannot access appropriate treatment outside of the clinical study protocol.
    Las pacientes seguirán recibiendo el tratamiento del estudio despues del cierre de la base de datos si en opinion del investigador, ellas contiuan recibiendo beneficios del tratamiento con fulvestrant o anastrazol y no pueden acceder a un tratamiento adecuado fuera del protocolo del estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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