Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001552-36
    Sponsor's Protocol Code Number:18SEIN08
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-07-03
    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 number2018-001552-36
    A.3Full title of the trial
    The use of FES-PET imaging as a tool to detect a possible reversion of Estrogen Receptor (ER)-α status in patients with metastatic breast cancer HER2 + and ERα neg treated with trastuzumab + pertuzumab + taxane.
    La TEP-FES comme outil de détection d’une possible réversion du statut REα chez des patientes présentant un cancer du sein métastatique HER2+ et REα neg traitées par trastuzumab + pertuzumab + taxane.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of FES-PET imaging as a tool to detect a possible reversion of Estrogen Receptor (ER)-α status in patients with metastatic breast cancer HER2 + and ERα neg treated with trastuzumab + pertuzumab + taxane.
    La TEP-FES comme outil de détection d’une possible réversion du statut REα chez des patientes présentant un cancer du sein métastatique HER2+ et REα neg traitées par trastuzumab + pertuzumab + taxane.
    A.3.2Name or abbreviated title of the trial where available
    REVER
    REVER
    A.4.1Sponsor's protocol code number18SEIN08
    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 SponsorINSTITUT CLAUDIUS REGAUD
    B.1.3.4CountryFrance
    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 supportCyclopharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT CLAUDIUS REGAUD
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressIUCT-O - 1, avenue Irène Joliot-Curie
    B.5.3.2Town/ cityTOULOUSE Cedex 09
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number+33531 15 51 04
    B.5.5Fax number+33531 15 58 96
    B.5.6E-maildalenc.florence@iuct-oncopole.fr
    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®
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Cyclopharma S.A.
    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 Solution for 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 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
    Metastatic breast cancer HER2 + and ERα neg.
    Cancer du sein métastatique HER2+ et REα neg.
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer HER2 + and ERα neg.
    Cancer du sein métastatique HER2+ et REα neg.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The main objective of the study is to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.
    L’objectif principal de l’étude est de mettre en évidence par TEP-18FES, qu’un traitement anti-HER2 par trastuzumab + pertuzumab peut reverser le statut REα chez des patientes présentant un cancer du sein métastatique HER2+ et REα neg.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - Evaluate if there is a discrepancy between the RE α neg phenotype determined in immuno-histochemistry and by FES-PET imaging before any treatment.
    - Study the expression of the ER α by FES-PET imaging according to the tumor metastatic sites before and during the anti-HER2 treatment.
    - Correlate the fixation obtained between FDG-PET and FES-PET imaging before the start of the treatment.
    - Correlate the fixation obtained in FES-PET imaging before and during the treatment.
    - Evaluate the adverse effects of FES-PET imaging.
    Les objectifs secondaires sont les suivants :
    - Evaluer s’il existe avant tout traitement, une discordance entre le phénotype REα neg déterminé en immuno-histochimie et par TEP-18FES.
    - Etudier l’expression du REα en TEP-FES selon les sites métastatiques tumoraux avant et pendant le traitement anti-HER2.
    - Corréler la fixation obtenue entre TEP au FDG et TEP au FES avant le début du traitement.
    - Corréler la fixation obtenue en TEP-FES avant et pendant le traitement.
    - Evaluer les effets indésirables de la TEP-18FES.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
    3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
    4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
    5. OMS ≤ 2.
    6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
    7. Patient affiliated to a Social Health Insurance in France.
    8. Patient must provide written informed consent prior to any study specific procedures.
    1. Age ≥ 18 ans.
    2. Patiente présentant un cancer du sein métastatique HER2+ (IHC +++ et/ou amplification de HER2 en ISH selon les recommandations de l’ASCO), REα neg (soit 0% en IHC) et RP neg (soit 0% en IHC).
    3. Patiente éligible selon l’investigateur pour un traitement par trastuzumab + pertuzumab + taxane en première ligne métastatique.
    4. Biopsie d’une lésion tumorale disponible (matériel archivé) ou lésion tumorale biopsiable pour l’étude (tumeur primitive ou métastase autre qu’osseuse).
    5. OMS ≤ 2.
    6. Pour les patientes non ménopausées, utilisation d’une méthode contraceptive efficace à l’entrée dans l’étude et pendant toute la durée de l’étude.
    7. Patiente affiliée à un régime de Sécurité Sociale en France.
    8. Patiente ayant signé son consentement éclairé avant l’inclusion dans l’étude et avant toute procédure spécifique pour l’étude.
    E.4Principal exclusion criteria
    1. Any previous treatment for metastatic disease.
    2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
    3. Patient with isolated hepatic metastasis.
    4. Patient with hemostasis disorders.
    5. Unbalanced Diabètes.
    6. Patient with usual formal contraindication to PET/TDM Imaging.
    7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.
    8. Pregnant or breastfeeding women.
    9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
    10. Patient protected by law.
    1. Tout traitement antérieur pour la maladie métastatique.
    2. Traitement adjuvant antérieur par anticorps anti-HER2 datant de moins de 6 mois.
    3. Patiente ayant des métastases hépatiques isolées.
    4. Patiente ayant des troubles de l’hémostase.
    5. Diabète non équilibré.
    6. Patiente présentant une contre-indication formelle habituelle à l’examen TEP/TDM.
    7. Patiente ayant déjà débuté son traitement par trastuzumab, pertuzumab et taxane.
    8. Femme enceinte ou allaitante.
    9. Toute condition psychologique, familiale, géographique ou bien sociologique ne permettant pas de respecter le suivi médical et/ou les procédures prévues dans le protocole de l'étude.
    10. Patiente protégée par la loi.
    E.5 End points
    E.5.1Primary end point(s)
    The main judgment criterion is the rate of patients with conversion of FES - lesions in FES + lesions.
    Le critère de jugement principal est le taux de patientes présentant une conversion des lésions de FES – en FES +.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 3 Day 1 for each patient.
    Cycle 3 Jour 1 pour chaque patiente.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    - The discrepancy rate between the REα neg phenotype determined in immuno-histochemistry and by 18FES-PET imagiging before treatment.
    - The adverse events due to FES-PET imaging evaluated by the NCI-CTCAE version 4.03.
    Les critères secondaires sont :
    - Le taux de discordance entre le phénotype REα neg déterminé en immunohistochimie et par TEP-18FES avant traitement.
    - Les effets indésirables de la TEP-18FES évalués par le NCI-CTCAE version 4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cycle 4 Day 1 for each patient.
    Cycle 4 Jour 1 pour chaque patiente.
    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 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 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.8.3 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
    LVLS
    Dernière visite de la dernière patiente.
    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 months27
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months27
    E.8.9.2In all countries concerned by the trial days15
    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: 33
    F.1.3Elderly (>=65 years) No
    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 state33
    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
    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 Decision2020-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 10 00:34:31 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA