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    Summary
    EudraCT Number:2013-001710-15
    Sponsor's Protocol Code Number:GINECO-BR110
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-03
    Trial results View 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 number2013-001710-15
    A.3Full title of the trial
    Phase II study in patient in first line for HER - metastasis breast cancer treated with eribulin and bevacizumab
    ESSAI DE PHASE II EVALUANT L’ASSOCIATION ÉRIBULINE (HALAVEN®) + BEVACIZUMAB (AVASTIN®) CHEZ LES PATIENTES AYANT UN CANCER DU SEIN METASTATIQUE HER -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study in patient in first line for HER - metastasis breast cancer treated with eribulin and bevacizumab
    A.4.1Sponsor's protocol code numberGINECO-BR110
    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 SponsorARCAGY-GINECO
    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 supportRoche
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportEisai
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARCAGY-GINECO
    B.5.2Functional name of contact pointMARMION
    B.5.3 Address:
    B.5.3.1Street AddressHopital hotel dieu, 1 place du parvis de Notre dame
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75004
    B.5.3.4CountryFrance
    B.5.4Telephone number1 42348323
    B.5.5Fax number143262673
    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 HALAVEN
    D.2.1.1.2Name of the Marketing Authorisation holderEISAI
    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.3.1Product nameHalaven
    D.3.2Product code eribulin
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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 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 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 AVASTIN
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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.3.1Product namebevacizumab
    D.3.2Product code L01XC07
    D.3.4Pharmaceutical form Solution for infusion
    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) Yes
    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
    Patient with breast adenocarcinoma
    Patiente atteinte d’un adénocarcinome mammaire métastatique, histologiquement prouvé.
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Patiente atteinte d'un cancer du sein.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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
    evaluate the rate of non progressive patients at 12 months, -( control rate or non progressive rate)

    The desease controle rate will be evaluate with RECIST criteria1.1.
    Déterminer la proportion de patientes non progressives à 12 mois (Taux de contrôle de la maladie ou taux de non progression).
    Le taux de contrôle de la maladie sera évalué par le RECIST v1.1 et est défini comme le pourcentage de patientes dont le statut tumoral, un an après l’inclusion, est soit rémission complète, soit rémission partielle, soit maladie stable.
    Le taux de contrôle de la maladie, évalué par l’investigateur, sera calculé à partir de la date de l’inclusion.
    Les patientes considérées comme présentant une maladie évolutive doivent remplir au moins un des critères suivants : Présence d’anomalies radiologiques évolutives et apparition de symptômes reliés à la pathologie néoplasique.
    E.2.2Secondary objectives of the trial
    objective response rate
    Progression free survival
    Overall survival
    Toxicity
    Quality of life
    - Le taux de réponse objective de la maladie (RC et RP) selon les critères RECIST version 1.1 : est défini par le pourcentage de réponses complètes et de réponses partielles à partir de la date d’inclusion jusqu’à la fin de traitement.
    - La survie sans progression (SSP) : le temps jusqu’à progression écoulé entre la date d’inclusion et la date de la survenue d’une progression, ou la date d’une rechute dans le cas où une réponse complète a été observée, ou la date de décès qui serait intervenu avant qu’une progression ne soit objectivée.
    - La survie globale (SG) : la survie globale est calculée à partir de la date d’inclusion jusqu’au décès quelle qu’en soit la cause, et censurée à la date des dernières nouvelles.
    - Le profil de toxicité : évaluation des événements indésirables selon le CTCAE v4.03.
    - Qualité de vie : évaluation du bien-être grâce à une échelle visuelle analogique (EVA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient with a metastasis breast adenocarcinoma, based on histology
    Positives or negatives hormonal RP and RE receptors, HER 2 negativ, with prersence of at least one mesurable lesion.
    Biology as follow :
    Neutrophils > 1,5 x 109/L
    Platelets > 100 x 109/L
    Hémoglobin > 9,0 g/dL
    Bilirubin < 1,5 LSN (Limite Supérieure Normale)
    Transaminases (ASAT et ALAT et PAL) < 1,5 x upper limit for patient without hepatic metastasis hépatiques et and < 3 if hepatic metastasis
    Age > 18 ans.
    Availabilty to follows the protocole's rules.
    Patiente atteinte d’un adénocarcinome mammaire métastatique, histologiquement prouvé
    -Récepteurs hormonaux RP et RE positifs ou négatifs, statut HER 2 négatif
    -Présence d’une ou de plusieurs lésion(s) mesurable(s) ou évaluables(s).
    En cas de lésion(s) osseuse(s) isolée(s) : critères minimum pour les considérer comme lésion(s) cible(s) : hyperfixation scintigraphique associée à au moins l’un des critères suivants :
    preuve cytologique ou histologique,
    image radiographique typique,
    élévation du CA15-3.
    -Bilan biologique satisfaisant, selon les critères suivants:
    Neutrophiles > 1,5 x 109/L
    Plaquettes > 100 x 109/L
    Hémoglobine > 9,0 g/dL
    Bilirubine < 1,5 LSN (Limite Supérieure Normale)
    Transaminases (ASAT et ALAT) et phosphatase alcaline < 1,5 x LSN pour les patientes sans métastases hépatiques et < 3 x LSN si présence de métastases hépatiques.
    Clairance de la créatinine > 40 mL/min selon la formule de Cockroft-Gault.
    Potassium et magnésium > Limite Inférieure Normale. Le cas échéant, l'hypokaliémie et l'hypomagnésémie doivent être corrigées avant le début du traitement.
    Protéinurie à la bandelette urinaire < 2+ (si ≥ 2+, la protéinurie de 24h doit être < 1 g)
    Chez les patientes ne recevant pas de traitement anticoagulant :
    Taux de prothrombine (TP) > 70%
    Temps de céphaline activée (TCA) < 1,5 LSN
    Les patientes qui reçoivent des anticoagulants oraux ou parentéraux peuvent être incluses dans l’essai si le taux d’anti-coagulation est stable depuis au moins 2 semaines avant l’inclusion, d’après les tests de coagulation pratiqués habituellement par le centre.
    -Etat de performance ECOG 0 ou 1.
    -Résolution de toute toxicité > grade 2 liée au traitement adjuvant éventuel
    -Espérance de vie d’au moins 12 semaines.
    -Age > 18 ans.
    -Capacité à suivre le protocole.
    -Consentement éclairé signé avant toute procédure spécifique de l’étude.
    -Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    Previous chemotherapy
    Previoulsy treated with eribulin or bevacizumab
    brain metastasis
    previous cancer ( exept cancer treated with no relase within the 5 years before the start of the study)
    Participation in another study within the previous 30 days
    - Chimiothérapie antérieure en situation métastatique.
    - Traitement antérieur par éribuline ou bevacizumab
    - Présence de métastases cérébrales ou méningées symptomatiques
    - Antécédent d’un autre cancer, à l’exception de cancers convenablement traités, sans signe de récidive depuis 5 ans
    - Participation à une autre étude clinique avec des médicaments expérimentaux dans les 30 jours qui précèdent l’entrée dans l’étude
    - Femme enceinte ou allaitant, ou femme en âge de procréer et n’utilisant pas de contraception adéquate pendant le traitement et au minimum 6 mois après la fin du traitement. Le test urinaire ou sérique de grossesse effectué dans les 72 h précédant le début du traitement de l’étude doit être négatif.
    - Pathologie sévère ou concomitante non compatible avec la prise du traitement à l’étude ou la participation de la patiente à l’étude.
    - Neuropathie sensitive ou motrice préexistante de grade > 2
    - Maladie cardiaque cliniquement significative : accident cardio-vasculaire ou infarctus du myocarde dans les 6 mois précédant l’inclusion, angor instable, insuffisance cardiaque congestive classe NYHA ≥ II, troubles de rythme, dyspnée nécessitant un repos strict ou une oxygénation permanente.
    - Intervalle QT corrigé (QTc) > 480 ms lors de la sélection, ou syndrome de QT long congénital.
    - Hypertension artérielle non contrôlée (> 150/100). Le recueil de la tension artérielle à domicile est accepté.
    - Antécédents de maladie thrombotique ou hémorragique dans les 6 mois précédant l’inclusion
    - Antécédents de coagulopathie
    - Antécédents de fistule abdominale, perforation gastro-intestinale, ou d’abcès intra abdominal dans les 6 mois précédant l’inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival at 1 year ( RECIST 1.1 )
    Taux de non progression à 1 an selon les critères RECIST1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    CA125 at each cycle
    CT scan at baseline and every 3 months
    CA 125 à tous les cycles
    CT scan baseline et tous les 3 cycles
    E.5.2Secondary end point(s)
    Objective response rate
    overall survival
    Toxicity
    quality of life
    Taux de reponse objectives
    Toxicités dose-limitantes, selon les critères CTCAE v4.03
    Qualité de vie
    E.5.2.1Timepoint(s) of evaluation of this end point
    quality of life questionnaires
    questionnaires de qualité de vie
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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 dernière patiente
    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 months
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 59
    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 Decision2013-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-26
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