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    Summary
    EudraCT Number:2013-000287-29
    Sponsor's Protocol Code Number:ET-FES00119
    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:2014-03-27
    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 number2013-000287-29
    A.3Full title of the trial
    EARLY PREDICTION OF EFFICACY OF ENDOCRINE THERAPY IN BREAST CANCER: PILOT STUDY AND VALIDATION WITH 18F FLUOROESTRADIOL (FES) PET/CT
    Valutazione precoce dell’efficacia del trattamento ormonale nel carcinoma mammario: studio di validazione della metodica CT/PET con 18F Fluoroestradiolo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EARLY PREDICTION OF EFFICACY OF ENDOCRINE THERAPY IN BREAST CANCER: PILOT STUDY AND VALIDATION WITH 18F FLUOROESTRADIOL (FES) PET/CT
    Valutazione precoce dell’efficacia del trattamento ormonale nel carcinoma mammario: studio di validazione della metodica CT/PET con 18F Fluoroestradiolo
    A.3.2Name or abbreviated title of the trial where available
    ET-FES
    ET-FES
    A.4.1Sponsor's protocol code numberET-FES00119
    A.5.4Other Identifiers
    Name:alessandra.gennari@med.uniupo.itNumber:stefania.cresta@med.uniupo.it
    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 SponsorUniversità del Piemonte Orientale
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTRANSCAN
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisatione.o. ospedali galliera
    B.5.2Functional name of contact pointalessandra.gennari@med.uniupo.it
    B.5.3 Address:
    B.5.3.1Street Addressstefania.cresta@med.uniupo.it
    B.5.3.2Town/ citygiancarlo.avanzi@med.uniupo.it
    B.5.3.3Post code16128
    B.5.3.4CountryItaly
    B.5.4Telephone number00390105634212
    B.5.6E-mailsara.campora@galliera.it
    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 name16-α-[18F]fluoro-17-β-fluoroestradiol
    D.3.2Product code 16-α-[18F]fluoro-17-β-fluoroestradiol
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular and intravenous use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN18-F Fluoroestradiol
    D.3.9.2Current sponsor code18 FES
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/g megabecquerel(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with histologically or cytologically confirmed ER-positive MBC at first evidence of metastatic disease.
    tumore alla mammella metastatico
    E.1.1.1Medical condition in easily understood language
    Patients with histologically or cytologically confirmed ER-positive MBC at first evidence of metastatic disease.
    tumore alla mammella metastatico
    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
    Disease Control Rate, as defined by the proportion of patients who do not experience disease progression within 3 months of treatment.
    : L'obiettivo primario di questo studio è quello di confrontare l'attività della prima linea di terapia endocrina contro una prima linea di chemioterapia nel carcinoma mammario metastatico in pazienti con fenotipi ER-positivi e SUV 18F-FES <2 alla valitazione basale con TAC / PET
    E.2.2Secondary objectives of the trial
    The primary objective of this study is to compare the activity of first line endocrine
    therapy versus first line chemotherapy in MBC in patients with ER-positive
    phenotypes and SUV 18F-FES < 2 at basal CT/PET scan.
    1.Valutare il Rate di Controllo della Malattia con tp endocrina in pz con 18F-FES SUV>2
    2.Confrontare il Rate di Controllo della Malattia con tp endocrina osservata nei pz con 18F-FES SUV>2 e con 18F-FES SUV<2
    3.Valutare il Rate di Controllo della Malattia, entro 24 sett di tp
    4.Correlare espressione di ER nel primitvo e in generale FES-uptake in mts
    5.Correlare l'espressione di ER in biopsie sul tumore mts(se possibile)e nel primitivo.
    6.Valutare espressione genica degli estrogeni correlati mediante PCR sui primitvi e mts(sedisponibili)
    7.Correlare tasso di risp(RECIST1.1) di singole lesioni mts con il loro assorbimento attraverso il 18F-FES
    8.Sviluppare e validare nuovi test per predire la resistenza endocrina nei tumori ER+,sulla valutazione di fattori quali espressione ER/PgR, HER2/3, membri della famiglia SRCs
    (steroid co-receptor activators).
    9.Combinare le info biologiche e funzionali per costruire un algoritmo di predizione
    della risposta a tp endocrina in pz ER+ MBC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed breast cancer
    - Metastatic disease, stage IV
    - No prior treatments for metastatic breast cancer
    - HER2 negative disease, as measured locally by IHC or FISH (standard clinical practice)
    - Endocrine-sensitive disease as evaluated locally, by ER expression at the time of diagnosis on the primary tumor.
    - Prior endocrine therapy is allowed only in the adjuvant setting
    - Prior adjuvant/neoadjuvant chemotherapy is allowed provided it is terminated at least 12 months before study entry. Adjuvant anthracyclines and adjuvant taxanes are allowed.
    - Patients progressed during or after adjuvant endocrine therapy are eligible
    - Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
    - Measurable or non measurable, but evaluable disease.
    - Visceral, and/or soft tissue and/or bone metastases
    - Eastern Cooperative Oncology Group (ECOG) performance status < 2
    - Life expectancy > 3 months
    - No history of other malignancies
    - Signed written informed consent
    - Ability to comply with the study protocol
    - Age 18 years or older
    - Availability of an FFPE block from the primary tumor (breast lesion) for submission to central pathology review.
    - A biopsy of metastatic lesions is recommended, if technically feasible.
    -Tumore alla mammella confermato istologicamente o citologicamente
    -Malattia metastatica, stadio IV
    -Nessun precedente trattamento per il tumore alla mammella metastatico
    -Malattia HER2 negativo, misurata a livello locale da IHC o FISH (pratica clinica standard)
    -Patologia endocrino sensibile, valutato localmente mediante espressione di ER al momento della diagnosi sul tumore primario
    -Precedente terapia endocrina è consentita solo nel trattamento adiuvante
    -Precedente chemioterapia adiuvante/neoadiuvante è consentita a condizione che sia terminata almeno 12 mesi prima dell'ingresso nello studio. Sono ammesse antracicline adiuvanti e taxani adiuvanti
    -Sono ammessi i pazienti che sono progrediti durante o dopo la terapia endocrina adiuvante
    -La radioterapia, se effettuata e indipendentemente dalla sede, deve essere completata almeno 2 settimane prima della randomizzazione
    -Malattia misurabile o non misurabile, ma valutabile
    -Viscerale, e/o dei tessuti molli e/o metastasi ossee
    -Eastern Cooperative Oncology Group (ECOG) performance status < 2
    -Aspettativa di vita > 3 mesi
    -Non precedenti altri tumori maligni
    -Firmato il consenso informato scritto
    -Capacità di rispettare il protocollo di studio
    -Maggiori di 18 anni
    -Disponibilità di un blocco FFPE del tumore primario (lesione del seno) per la revisione centralizzata
    -Una biopsia sulla lesione metastatica è consigliata, se tecnicamente possibile
    E.4Principal exclusion criteria
    - HER-2 positive disease
    - Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the two weeks before entry into the study
    - Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
    - Brain or leptomeningeal metastases
    - Malattia HER-2 positivo
    - L'uso di ligandi del recettore degli estrogeni, inclusi tamoxifene, fulvestrant o estrogeni, durante le due settimane prima dell'entrata in studio
    -Storia di precedente altra neoplasia (tranne il carcinoma delle cellule basali adeguatamente controllata della pelle, carcinoma in situ della cervice, carcinoma in situ della vescica)
    - Metastasi cerebrali o leptomeningee
    E.5 End points
    E.5.1Primary end point(s)
    Disease Control Rate, as defined by the proportion of patients who do not experience disease progression within 3 months of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36
    E.5.2Secondary end point(s)
    3. To evaluate Disease Control Rate, within 24 weeks of treatment.
    4. To correlate ER expression in the primary tumor and overall FES-uptake in metastases.
    5. To correlate ER expression in metastatic biopsies (when available) and in the primary tumor.
    6. To evaluate estrogen-related gene expression by PCR on primary tumors and available metastatic biopsies.
    7. To correlate the response rate (according to RECIST 1.1) of individual metastatic lesions with their 18F-FES uptake.
    8. To develop and validate newer tests able to predict endocrine resistance in ER+
    tumors, based on the assessment of factors such as PgR expression, oncogenerelated
    escape pathways and steroid receptor co-activators.
    9. To combine biological and functional information to construct a prediction
    algorithm of endocrine responsiveness in ER+ MBC
    1. Valutare il Rate di Controllo della Malattia con la terapia endocrina in pazienti con 18F-FES
    SUV>2.
    2. Confrontare il Rate di Controllo della Malattia con la terapia endocrina osservata nei pazienti con
    18F-FES SUV>2 con quella di pazienti con 18F-FES SUV<2.
    3. Valutare il Rate di Controllo della Malattia, entro le 24 settimane di trattamento.
    4. Correlare l'espressione di ER nel tumore primario e in generale FES-uptake in metastasi.
    5. Correlare l'espressione di ER in biopsie sul tumore metastatico (quando disponibili) e nel tumore
    primario.
    6. Valutare l’espressione genica degli estrogeni correlati mediante PCR sui tumori primari e
    metastatici in cui sono disponibili le biopsie.
    7. Correlare il tasso di risposta (secondo RECIST 1.1) di singole lesioni metastatiche con il loro
    assorbimento attraverso il 18F-FES.
    8. Sviluppare e validare nuovi test in grado di predire la resistenza endocrina nei tumori ER +, in
    base alla valutazione di fattori quali espressione ER/PgR, HER2/3, membri della famiglia SRCs
    (steroid co-receptor activators).
    9. Combinare le informazioni biologiche e funzionali per la costruzione di un algoritmo di predizione
    della risposta alla terapia endocrina in pazienti ER + MBC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 310
    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)
    Follow-up clinico e strumentale
    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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-22
    P. End of Trial
    P.End of Trial StatusOngoing
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