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    Summary
    EudraCT Number:2011-006326-24
    Sponsor's Protocol Code Number:D699C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-28
    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 ConcernedItaly - Italian Medicines Agency
    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 (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy (FALCON)
    Studio di fase III, randomizzato, in doppio cieco, a gruppi paralleli, multicentrico, per confrontare l'efficacia e la tollerabilita' del Fulvestrant (FASLODEXTM) 500 mg con Anastrozolo (ARIMIDEXTM) 1 mg come trattamento ormonale per donne in post-menopausa, affette da cancro al seno localmente avanzato o metastatico positivo a recettori ormonali che non siano state precedentemente trattate con una terapia ormonale (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
    Uno studio globale per confrontare gli effetti del fulvestrant ed arimidex in una sottopopolazione di pazienti con cancro al seno
    A.3.2Name or abbreviated title of the trial where available
    FALCON
    FALCON
    A.4.1Sponsor's protocol code numberD699C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01602380
    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 AB
    B.5.2Functional name of contact pointINFORMATION CENTER
    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.5.4Telephone numberNOT APPLICABLE
    B.5.5Fax numberNOT APPLICABLE
    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*IM 2SIR 5ML+2AGHI
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder and solvent for solution for injection/infusion
    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 codeICI 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*28CPR RIV 1MG
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.4EV 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 placeboConcentrate for solution for injection/infusion
    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
    Cancro al seno positivo per i recettori degli estrogeni, naive per terapia ormonale, cancro al seno, cancro al seno neoplastico, tumore metastatico, neoplasia
    E.1.1.1Medical condition in easily understood language
    hormone receptor positive breast cancer, hormone naive, breast
    cancer, neoplasm, metastatic tumour
    Cancro al seno positivo per i recettori degli estrogeni, naive per terapia ormonale, cancro al seno, tumore metastatico, neoplasia
    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
    Dimostrare una superiore sopravvivenza senza progressione (progression-free survival, PFS) nelle pazienti trattate con fulvestrant 500 mg rispetto alle pazienti trattate con anastrozolo 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
    Confrontare la sopravvivenza generale, la risposta oggettiva, la risposta in termini di beneficio clinico, la qualità della vità, il profilo di sicurezza, per i pazienti in studio
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:1.0
    Date:2012/05/01
    Title:A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study
    to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM)
    500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for
    Postmenopausal Women with Hormone Receptor-Positive Locally
    Advanced or Metastatic Breast Cancer Who Have Not Previously Been
    Treated With Any Hormonal Therapy (FALCON)
    Objectives:The exploratory objective of the study is to explore how variations in tumour biomarkers(DNA, RNA and/or protein based) may be related to factors that may influence development of cancer and/or study treatment response and resistance.

    FARMACOGENETICA:
    Vers:1.0
    Data:2012/05/01
    Titolo: Studio di fase III, randomizzato, in doppio cieco, a gruppi paralleli, multicentrico, per confrontare l’efficacia e la tollerabilità del Fulvestrant (FASLODEXTM) 500 mg con Anastrozolo (ARIMIDEXTM) 1 mg come trattamento ormonale per donne in post-menopausa, affette da cancro al seno localmente avanzato o metastatico positivo a recettori ormonali che non siano state precedentemente trattate con una terapia ormonale (FALCON).
    Obiettivi:Esplorare come le variazioni nei biomarcatori tumorali (DNA, RNA e/o proteici) possano essere correlate a fattori che potrebbero influenzare lo sviluppo del cancro e/o la risposta e la resistenza al trattamento in studio.

    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 Conferma istologica del carcinoma mammario in donne in post menopausa (età≥60).
    2 Positività del recettore ormonale (positività ER e/o positività PgR) del tessuto tumorale primario o metastatico in base a valutazione del laboratorio locale.
    3 Avere O
    una malattia localmente avanzata, non idonea per chirurgia o radioterapia con intento curativo. Le pazienti possono aver avuto una linea di chemioterapia citotossica, ma devono restare non idonee per una terapia con intento curativo.
    OPPURE
    una malattia metastatica.
    Le pazienti possono aver avuto una linea di chemioterapia citotossica come precedente trattamento del carcinoma mammario, ma devono mostrare progressione di malattia prima dell’arruolamento.
    4 Almeno 1 lesione (misurabile e/o non misurabile) che possa essere accuratamente valutata al basale e sia idonea per valutazioni ripetute .
    5 Donna postmenopausale, definita come una donna che soddisfi 1 qualsiasi dei seguenti criteri :
    Ovariectomia bilaterale pregressa
    Età ≥60 anni
    Età &lt;60 anni e amenorreiche da 12 mesi o più in assenza di chemioterapia, tamoxifene, toremifene, o soppressione ovarica e ormone follicolo-stimolante ed estradiolo nell’intervallo postmenopausale.
    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. Presenza di malattia metastatica che mette in pericolo di vita, definita come esteso coinvolgimento epatico o qualsiasi grado di coinvolgimento cerebrale o leptomeningeo, oppure diffusione linfangitica polmonare sintomatica. Sono idonee le pazienti con singole metastasi parenchimali polmonari, a condizione che la loro funzione respiratoria non sia compromessa in modo significativo.
    2. Precedente terapia sistemica per il carcinoma mammario, diversa da una linea di chemioterapia citotossica (l’ultima dose di chemioterapia deve essere stata ricevuta più di 28 giorni prima della randomizzazione).
    3. Radioterapia, se non completata entro 28 giorni prima della randomizzazione (con l’eccezione della radioterapia fornita per il controllo del dolore osseo, che deve essere completata prima del giorno di randomizzazione).
    4. Precedente trattamento ormonale per il carcinoma mammario.
    5. Malignità attuale o pregressa (diversa dal carcinoma mammario o dal carcinoma cutaneo basocellulare o squamocellulare adeguatamente trattato oppure dal carcinoma della cervice in situ).
    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
    Confrontare la sopravvivenza libera da progressione in pazienti trattati con fulvestrant rispetto pazienti trattati con anastrozole
    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.
    Valutazione RECIST 1.1 al baseline e successivamente ogni 12 settimane sino a evidente progressione di malattia, o morte del paziente o chirurgia/radioterapia per la malattia
    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 Confrontare la sopravvivenza complessiva (overall survival, OS) nelle pazienti trattate con fulvestrant 500 mg rispetto alle pazienti trattate con anastrozolo 1 mg, quando il 50% dei pazienti sono classificati come deceduti
    2 Confrontare il tasso di risposta obiettiva (objective response rate, ORR), nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo. (ORR= % di pazienti classificati come in risposta parziale PR o in risposta completa CR)
    3 Confrontare la durata della risposta (DoR) nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo. (DoR= giorni dalla PR/CR alla progressione oggettiva della malattia)
    4 Confrontare la durata della risposta attesa (expected duration of response, EDoR) nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo. (EDoR= p Efp(x), dove x=DoR, p=proporzione dei responders, Efp(x) significa durata della risposta
    5 Confrontare il tasso di beneficio clinico (clinical benefit rate, CBR), nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo. (CBR = proportion di pazienti classificati come in PR /CR o malattia stabile per almeno 154 giorni
    6 Confrontare la durata del beneficio clinico (duration of clinical benefit, DoCB) nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo. (DoCB= per i pazienti classificati come responders per solo beneficio clinico, giorno dalla randomizzazioni sino alla data della progressione della malattia).
    7 6 Confrontare durata del beneficio clinico atteso (expected duration of clinical benefit, EDoCB) nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo. (EDoCB=p Efp(x), dove x=DoCB, p=proporzione dei responders, Efp(x) significa durata del beneficio clinico.
    8 Confrontare la qualità di vita correlata alla salute (health related quality of life, HRQoL) nelle pazienti trattate con fulvestrant rispetto alle pazienti trattate con anastrozolo.
    9 Valutare la sicurezza e la tollerabilità del trattamento con fulvestrant rispetto a quello con anastrozolo dall’analisi degli eventi avversi, esame obiettivo, ECG, segni vitali, peso, analisi ematologiche e biochimiche.
    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 Dopo progressione i pazienti saranno contattati ad intervalli regolari di 12 settimane per determinare lo stato di sopravvivenza.
    2 Gli obiettivi 2-7, valutazione RECIST 1.1 al baseline ed ogni 12 settimane
    8 Questionari di qualità della vita completati al baseline, ogni 12 settimane durante il trattamento, o ogn 24 settimane per i pazienti in follow-up seguiti per la sopravvivenza.
    9 per l'analisi primaria:Gli eventi avversi saranno raccolti dalla firma del consenso sino a 56 giorni dopo l'ultima iniezione. I segni viatali saranno raccolti ad ogni visita di trattamento; ECGs, ematologia e biochimica saranno condotti dalla randomizazzione ogni and 12 settimane sino a 35 giorni dopo l'ultima iniezione. A seguito dell'analisi primaria solo i SAE saranno raccolti.
    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
    India
    Japan
    Mexico
    Peru
    Russian Federation
    South Africa
    Taiwan
    Turkey
    Ukraine
    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
    Il database è chiuso dopo l'ultima visita/analisi paziente che contribuisce all'analisi di sopravvivenza generale, condotta quando circa 50% dei pazienti son deceduti.La fine dello studio è definita come ultima visita ultimo paziente, quando discont
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months57
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months57
    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.1.1Number of subjects for this age range: 0
    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 state38
    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 study 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.
    I pazienti continueranno a ricevere il trattamento di studio oltre la chiusura del database, se ad opinione dello sperimentatore, continuano ad ottenere beneficio dal trattamento con fulvestrant o anastrozole, e non possono accedere ad un trattamento appropriato fuori dal protocollo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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