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    Summary
    EudraCT Number:2013-000287-29
    Sponsor's Protocol Code Number:ET-FES-STUDY-174-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-02-09
    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 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
    Predicción precoz de eficacia de la terapia endocrina en cáncer de mama: estudio piloto y validación con 18F Fluoroestradiol (FES) PET/TC.
    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
    Predicción precoz de eficacia de la terapia endocrina en cáncer de mama: estudio piloto y validación con 18F Fluoroestradiol (FES) PET/TC.
    A.3.2Name or abbreviated title of the trial where available
    ET-FES STUDY 174-01
    ET-FES STUDY 174-01
    A.4.1Sponsor's protocol code numberET-FES-STUDY-174-01
    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 Sponsore.o. ospedali galliera
    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 supporte.o. ospedali galliera
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Vall Hebron
    B.5.2Functional name of contact pointSecretaria Servicio Oncologia
    B.5.3 Address:
    B.5.3.1Street AddressPasseig de la Vall d'Hebron 119
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number00349348930006085
    D. IMP Identification
    D.IMP: 1
    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 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-?-[18F]fluoro-17-?-fluoroestradiol
    D.3.2Product code 16-?-[18F]fluoro-17-?-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 INN16-?-[18F]fluoro-17-?-fluoroestradiol
    D.3.9.3Other descriptive name16ALFA-18F-FLUORO-17BETA-ESTRADIOL
    D.3.9.4EV Substance CodeSUB130959
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    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.
    Pacientes con cáncer de mama metastásico (MBC) ERpositivo confirmado por histología o citología en la primera evidencia de metástasis.
    E.1.1.1Medical condition in easily understood language
    metastatic breast cancer
    cáncer de mama metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Disease Control Rate, as defined by the proportion of patients who do not experience disease progression within 3 months of treatment.
    El objetivo principal de este estudio es comparar la actividad de primera línea de tratamiento endocrino frente a la quimioterapia de primera línea en pacientes con MBC en fenotipos ER-positivos y SUV 18F - FES < 2 en TC / PET basal.
    E.2.2Secondary objectives of the trial
    1. To evaluate Disease Control Rate with endocrine therapy in patients with 18F-FES SUV > 2.
    2. To compare the Disease Control Rate with endocrine therapy observed in patients with 18F-FES SUV > 2 with that of patients with 18F-FES SUV < 2.
    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.
    1. Evaluar la tasa de beneficio clínico con la terapia endocrina en pacientes con 18F-FES SUV ? 2.
    2. Comparar la tasa de beneficio clínico con la terapia endocrina observado en pacientes con 18F - FES SUV ? 2 con la de los pacientes con 18F - FES SUV < 2.
    3. Evaluar la tasa de beneficio clínico, dentro de las 24 semanas de tratamiento.
    4. Correlacionar la expresión de ER en el tumor primario y la absorción de FES en las metástasis.
    5. Correlacionar la expresión de ER en las biopsias de metástasis (cuando está disponible) y en el tumor primario.
    6. Evaluar la expresión génica relacionada con estrógenos mediante PCR en biopsias de tumores primarios y metastásicos disponibles.
    7. correlacionar la tasa de respuesta (según RECIST 1.1) de las lesiones metastásicas individuales con su captación de 18F-FES.
    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.
    - Cáncer de mama confirmado Histológicamente o citológicamente
    - Enfermedad metastásica, estadio IV
    - Sin tratamientos previos para el cáncer de mama metastásico.
    - Tumor HER2 negativo, determinado a nivel local por IHC o FISH (según la práctica clínica estándar)
    - Enfermedad sensible a terapia endocrina evaluada localmente, por la expresión ER en el momento del diagnóstico sobre el tumor primario.
    - Terapia endocrina previa, sólo se permite en el tratamiento adyuvante
    - Se permite quimioterapia adyuvante/neoadyuvante previa siempre y cuando finalice al menos 12 meses antes de entrar en el estudio. Se permiten antraciclinas y taxanos en contexto adyuvante.
    - Los pacientes que progresaron durante o después de la terapia endocrina adyuvante son elegibles
    - La radioterapia, si se les da y con independencia de sitio, debe ser completada por lo menos 2 semanas antes de la aleatorización.
    - Enfermedad medible o no medible, pero evaluable.
    - Metástasis viscerales, y/o de los tejidos blandos y/o óseas.
    - Eastern Cooperative Oncology Group ( ECOG ) PS < 2
    - Esperanza de vida > 3 meses
    - Sin antecedentes de otras neoplasias malignas
    - Firmar el consentimiento informado por escrito
    - Capacidad para cumplir con los procedimientos del estudio
    - Edad >18 años
    - Disponibilidad de un bloque FFPE del tumor primario (lesión de la mama) para someterlo a revisión central .
    - Se recomienda una biopsia de las lesiones metastásicas, si es técnicamente factible.
    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
    - HER- 2 positivo
    - El uso de ligandos del receptor de estrógeno , incluyendo el tamoxifeno, fulvestrant o estrógenos, durante las dos semanas antes de entrar en el estudio
    - Historia previa de otro cáncer invasivo (excepto para el carcinoma de células basales adecuadamente controlada de la piel, carcinoma in situ del cuello uterino, carcinoma in situ de la vejiga).
    - Metástasis cerebrales o leptomeníngeas.
    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.
    Tasa de beneficio clínico, según la definición de la proporción de pacientes que no experimentan progresión de la enfermedad dentro de 3 meses de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    E.5.2Secondary end point(s)
    No secondary end point
    No hay variables secundarias
    E.5.2.1Timepoint(s) of evaluation of this end point
    No secondary end point
    No hay variables secundarias
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    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)
    Clinical and instrumental monitoring
    Seguimiento clínico e instrumental
    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 Decision2015-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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