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    Summary
    EudraCT Number:2021-003601-21
    Sponsor's Protocol Code Number:ZX-2021-FES-ESTROTIMP-4.
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003601-21
    A.3Full title of the trial
    Impact of 18F-FES TEP on therapeutical management in patients with metastatic breast cancer, ER positive and HER2 negative, in relapse after a first line of treatment combining hormonal therapy
    Impact de la Tomographie par Emission de Positons (TEP) au 18FFluoroestradiol (FES) sur la prise en charge thérapeutique chez des patientes atteintes d’un cancer du sein métastatique RE+ et HER2- en rechute après une première ligne associant l’hormonothérapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of 18F-FES TEP on therapeutical management in patients with metastatic breast cancer, ER positive and HER2 negative, in relapse after a first line of treatment combining hormonal therapy
    Impact de la Tomographie par Emission de Positons (TEP) au 18FFluoroestradiol (FES) sur la prise en charge thérapeutique chez des patientes atteintes d’un cancer du sein métastatique RE+ et HER2- en rechute après une première ligne associant l’hormonothérapie
    A.3.2Name or abbreviated title of the trial where available
    ESTROTIMP
    A.4.1Sponsor's protocol code numberZX-2021-FES-ESTROTIMP-4.
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/055/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorZionexa
    B.1.3.4CountryFrance
    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 supportZionexa
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZionexa
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address4 allée du groupe Nicolas Bourbaki
    B.5.3.2Town/ cityAUBIERE
    B.5.3.3Post code63170
    B.5.3.4CountryFrance
    B.5.4Telephone number+336 74 03 86 00
    B.5.5Fax number+334 20 10 00 50
    B.5.6E-mailclinicaltrials@zionexa.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 ESTROTEP 500 MBq/mL, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderZionexa
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression of HER2, relapsing after a first therapeutic line combining hormone therapy.
    Patientes atteintes d'un cancer du sein métastatique présentant initialement une surexpression des récepteurs aux estrogènes (RE) et l’absence de surexpression d’HER2, en rechute après une première ligne thérapeutique associant l’hormonothérapie.
    E.1.1.1Medical condition in easily understood language
    metastatic breast cancer
    cancer du sein métastatique
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of FES PET / CT on the management of patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression of HER2, relapsing after a first therapeutic line combining hormone therapy.
    Évaluer l'impact de la TEP/TDM au FES sur la prise en charge des patientes atteintes d'un cancer du sein métastatique présentant initialement une surexpression des récepteurs aux estrogènes (RE) et l’absence de surexpression d’HER2, en rechute après une première ligne thérapeutique associant l’hormonothérapie.
    E.2.2Secondary objectives of the trial
    Clinical:
    1. Evaluate the impact of substantial therapeutic measures on progression-free survival of the 2nd midline, with constitution of a historical group
    2. Determine the relevance at 3 months of the therapeutic measures put in place following the FES PET / CT performed at baseline
    3. Identify parameters of FES PET / CT associated with substantial therapeutic measure
    Exploratory analyzes:
    1. The primary endpoint will be evaluated in the following sub-groups:
    - The type of breast cancer: ductal or lobular
    - Oligometastatic disease or not (threshold> 5 lesions)
    The stage of metastatic disease: metastatic from the outset or recurrent after curative treatment
    2. Compare the Quality of life of patients with substantial therapeutic measures versus others
    3. Perform a radiomic analysis of the imaging data (PET / CT FES baseline and images defining the 2nd line relapse (PET / CT FDG or scanner).
    Cliniques :
    1. Evaluer l’impact des mesures thérapeutiques substantielles sur la survie sans progression de 2ème ligne médiane, avec constitution d’un groupe historique
    2. Déterminer la pertinence à 3 mois des mesures thérapeutiques mises en place suite à la TEP/TDM au FES effectuée à baseline
    3. Identifier les paramètres de la TEP/TDM au FES associés à une mesure thérapeutique substantielle
    Analyses à titre exploratoire :
    1. Le critère principal sera évalué dans les sous-groupes suivants :
    - Le type de cancer du sein : canalaire ou lobulaire
    - La maladie oligométastatique ou non (seuil > 5 lésions)
    Le stade de la maladie métastatique : métastatique d’emblée ou récidivant après traitement curatif
    2. Comparer la Qualité de vie des patientes avec mesures thérapeutiques substantielles versus les autres
    3. Effectuer une analyse radiomique des données d’imagerie (TEP/TDM FES de baseline et images définissant la rechute de 2ème ligne (TEP/TDM FDG ou scanner).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Centralized proofreading as part of an ancillary study carried out after the end of the test could
    be considered.
    Une relecture centralisée dans le cadre d’une étude ancillaire réalisée après clôture de l’essai pourrait
    être envisagée.
    E.3Principal inclusion criteria
    1. Woman aged at least 18 years old on inclusion
    2. Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%)
    3. Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative)
    4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a hepatic lesion
    5. Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy
    6.Patient having performed a PET / CT with FDG during the follow-up of the first metastatic line defining the relapse or accepting to perform a PET / CT with the baseline FDG for the extension assessment (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES).
    7.ECOG 0, 1 or 2
    8. Life expectancy of at least 12 months
    1. Femme âgée de minimum 18 ans à l’inclusion
    2. Cancer du sein primitif exprimant les récepteurs hormonaux aux estrogènes en IHC (RE ≥ 10 %)
    3. Tumeur du sein primitive HER2 négatif (0, 1+, 2+ FISH négatif)
    4. Stade métastatique avec au moins une lésion identifiable sur le bilan conventionnel autre qu'une lésion hépatique
    5. Patiente en situation de récidive de la première ligne de traitement associant un inhibiteur CDK4/6 et une
    hormonothérapie
    6. Patiente ayant réalisée une TEP/TDM au FDG au cours du suivi de la première ligne métastatique définissant la rechute ou acceptant de réaliser une TEP/TDM au FDG de baseline pour le bilan d’extension (selon les recommandations du GBU des examens d’imagerie médicale). Un délai de 2 à 28 jours sera respecté entre les 2 TEP/TDM (FDG/FES).
    7. ECOG 0, 1 ou 2
    8. Espérance de vie d’au moins 12 mois
    E.4Principal exclusion criteria
    1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
    2. Patients in the first metastatic line or beyond the second metastatic line
    3. Person with a known allergy to any of the components of EstroTep
    4. Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD
    5. Woman of childbearing potential without effective contraception
    6. Serious intercurrent illness or co-morbidity assessed as risk
    1. Métastases hépatiques isolées (compte tenu de la fixation hépatique physiologique élevée du FES)
    2. Patientes en première ligne métastatique ou au-delà de la deuxième ligne métastatique
    3. Personne présentant une allergie connue à l’un des composants d’EstroTep
    4. Patientes ayant été traitées par un inhibiteur de CDK4/6 en association avec un SERM ou SERD en première ligne métastatique
    5. Femme en âge de procréer ne disposant pas de moyen de contraception efficace
    6. Maladie grave intercurrente ou comorbidité évaluée à risque
    E.5 End points
    E.5.1Primary end point(s)
    The therapeutic impact will be assessed by the percentage of patients for whom a substantial therapeutic measure has been implemented following the analysis of the PET-FES examination. This evaluation will be done using a standardized questionnaire filled in by the prescribing clinician prospectively, when requesting
    PET / CT at FES. This questionnaire will be completed again within a maximum of 15 days after the PET / CT FES in order to specify the final therapeutic measure. The treatment modality initially planned and that finally implemented can be determined in the RCP according to the centers. For the same patient, the questionnaire will be completed by the same investigator.
    Any modification of:
    - therapeutic modalities
    • change in the type of hormone therapy molecule
    • change in the type of chemotherapy molecule
    • addition of a systemic treatment molecule
    • withdrawal of a systemic treatment molecule
    • addition of radiotherapy treatment
    • stopping radiotherapy treatment
    • change in radiotherapy technique
    • change in radiotherapy protocol
    • programming of surgery
    • deprogramming of surgery
    - diagnostic modalities:
    • addition of a complementary exam
    • withdrawal of an additional examination
    • performing a biopsy
    - monitoring methods
    • adding an exam
    • withdrawal of an exam
    • increased frequency of follow-up
    • decrease in frequency of follow-up
    The other therapeutic measures will not be considered as substantial:
    - changes in processing methods
    • increase in dosage
    • decrease in dosage
    • increase in duration
    • reduction in duration
    - changes to the radiotherapy protocol: enlarged or restricted irradiation field of an already identified area
    L’impact thérapeutique sera évalué par le pourcentage de patientes pour lesquelles a été mise en place une mesure thérapeutique substantielle à la suite de l’analyse de l’examen TEP-FES. Cette évaluation se fera grâce à un questionnaire standardisé rempli par le clinicien prescripteur de façon prospective, lors de la demande de
    TEP/TDM au FES. Ce questionnaire sera à nouveau complété dans un délai maximum de 15 jours après la TEP/TDM FES afin de préciser la mesure thérapeutique finale. La modalité de prise en charge prévue initialement et celle mise en application finalement pourront être déterminés en RCP selon les centres. Pour une même patiente le questionnaire sera rempli par le même investigateur.
    Seront considérées comme mesures thérapeutiques substantielles toutes les modifications de :
    - modalités thérapeutiques
    • changement du type de molécule d’hormonothérapie
    • changement du type de molécule de chimiothérapie
    • ajout d’une molécule de traitement systémique
    • retrait d’une molécule de traitement systémique
    • ajout d’un traitement par radiothérapie
    • arrêt d’un traitement par radiothérapie
    • changement de technique de radiothérapie
    • changement du protocole de radiothérapie
    • programmation d’une chirurgie
    • déprogrammation d’une chirurgie
    - modalités diagnostiques :
    • ajout d’un examen complémentaire
    • retrait d’un examen complémentaire
    • réalisation d’une biopsie
    - modalités de suivi
    • ajout d’un examen
    • retrait d’un examen
    • augmentation de la fréquence du suivi
    • diminution de la fréquence du suivi
    Les autres mesures thérapeutiques ne seront pas considérées comme substantielles :
    - modifications des modalités du traitement
    • augmentation de la posologie
    • diminution de la posologie
    • augmentation de la durée
    • diminution de la durée
    - modifications du protocole de radiothérapie : champ d’irradiation élargi ou restreint d’une zone déjà identifiée
    E.5.1.1Timepoint(s) of evaluation of this end point
    After FES PET/CT (30 days max after inclusion)
    Après la TEP/TDM au FES (30 jours au maximum après inclusion)
    E.5.2Secondary end point(s)
    Primary secondary endpoints
    - 2nd line progression-free survival (PFS) is defined as the time between the date of the final therapeutic measure and relapse, by comparing the medians of progression-free survival (PFS) in the study population and in the cohort historical. The comparison will be made by the Kaplan Meier test with a 12-month censorship.
    - The relevance of the therapeutic measures put in place following the baseline PET / CT FES will be determined at 3 months on all the data in the patient's medical file (including the evaluation of the response to treatment) of the patient by an independent jury clinicians, made up of multidisciplinary members (an oncologist, a nuclear physician and a radiotherapist).
    Critères d’évaluation secondaires principaux
    - La survie sans progression (PFS) de 2ème ligne est définie comme le délai entre la date de la mesure thérapeutique finale et la rechute, en comparant les médianes des survies sans progression (PFS) dans la population de l’étude et dans la cohorte historique. La comparaison sera faite pas le test de Kaplan Meier avec une censure à 12 mois.
    - La pertinence des mesures thérapeutiques mises en place suite à la TEP/TDM FES de baseline sera déterminée à 3 mois sur l’ensemble des données du dossier médical (intégrant l’évaluation de la réponse au traitement) de la patiente par un jury indépendant de cliniciens, composé de membres multidisciplinaires (un oncologue, un médecin nucléaire et un radiothérapeute).
    E.5.2.1Timepoint(s) of evaluation of this end point
    -At 12 months
    -At 3 months
    -A 12 mois
    -A 3 mois









    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    Non randomisée avec ajout d'un groupe historique
    Non randomized with addition of historical group
    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 trial1
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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
    Last visit of last subject
    Dernière visite du dernier patient dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Constitution of a historical control group (retrospective observational of 152 patients)
    Constitution d’un groupe témoin historique (observationnel rétrospectif de 152 patientes)
    F.4 Planned number of subjects to be included
    F.4.1In the member state152
    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)
    None
    Aucun
    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 Decision2021-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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