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    Summary
    EudraCT Number:2015-004337-27
    Sponsor's Protocol Code Number:ICO-A-2015-03
    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:2016-06-07
    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 number2015-004337-27
    A.3Full title of the trial
    Evaluation of the impact of a Sandostatin injection before axillary node dissection on lymphorrhea in patients operated for breast cancer
    Evaluation de l'impact d'une injection de Sandostatine avant un curage axillaire sur les lymphocèles chez des patientes opérées pour un cancer du sein
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the impact of a Sandostatin injection before axillary node dissection on lymphorrhea in patients operated for breast cancer
    Evaluation de l'impact d'une injection de Sandostatine avant un curage axillaire sur les lymphocèles chez des patientes opérées pour un cancer du sein
    A.3.2Name or abbreviated title of the trial where available
    Sandostatin and lymphorrhea
    Sandostatine et lymphocèle
    A.4.1Sponsor's protocol code numberICO-A-2015-03
    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 de Cancérologie de l'Ouest
    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 supportInstitut de Cancérologie de l'Ouest
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Cancérologie de l'Ouest
    B.5.2Functional name of contact pointMagali BALAVOINE
    B.5.3 Address:
    B.5.3.1Street Address15 rue André Boquel
    B.5.3.2Town/ cityANGERS
    B.5.3.3Post code49055
    B.5.3.4CountryFrance
    B.5.4Telephone number0033241352931
    B.5.5Fax number0033244853715
    B.5.6E-mailmagali.balavoine@ico.unicancer.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 Sandostatine
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma SAS
    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 nameSandostatin
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) 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
    The population includes all patients who must have an axillary node dissection for non-metastatic breast cancer.
    La population comprend toutes les patientes devant avoir un curage axillaire pour un cancer du sein non métastatique.
    E.1.1.1Medical condition in easily understood language
    The population includes all patients who must have an axillary node dissection for non-metastatic breast cancer.
    La population comprend toutes les patientes devant avoir un curage axillaire pour un cancer du sein non métastatique.
    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
    The main objective is to reduce by 50% the incidence of lymphorrhea (change from 30% to 15%) following axillary node dissection in patients operated for breast cancer (without mastectomy) pre-treated with an injection of Sandostatine®.
    L’objectif principal est de diminuer de 50% l’incidence du lymphocèle (passage de 30% à 15%) suite à un curage axillaire des patientes opérées pour un cancer du sein (hors mastectomie) prétraitées par une injection de Sandostatine®.
    E.2.2Secondary objectives of the trial
    In this study, we have several secondary objectives:
    - Evaluation of the volume of punctures,
    - Evaluation of possible complications,
    - Evaluation of Sandostatine® tolerance,
    - Evaluation of the quality of life,
    - Evaluation of the cost of this care (medico-economic evaluation).
    Dans le cadre de cette étude, nous avons plusieurs objectifs secondaires :
    - évaluation du volume des ponctions,
    - évaluation des complications éventuelles,
    - évaluation de la tolérance de la Sandostatine®,
    - évaluation de la qualité de vie,
    - évaluation du coût de cette prise en charge (étude médico-économique).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Breast cancer, histologically proven
    2) Axillary node dissection programmed for breast cancer (+/-lumpectomy)
    3) Elective axillary surgery
    4) Age greater than or equal to 18 years
    5) Performans Status (WHO): 0, 1 or 2
    6) Satisfactory hematologic and hepatic results:
    Polymorphonuclear neutrophils higher or equal to 1.0 x109 / L, platelets greater than or equal to 100 x 109 / L, Total bilirubin less than or equal to 2 x ULN AST (SGOT) and ALT (SGPT) less than or equal to 3 x ULN (if hepatic metastasis less than or equal to 5 x ULN), PAL less than or equal to 5 x ULN
    7) Informed Consent, dated and signed.
    1) Cancer du sein, prouvé histologiquement
    2) Curage axillaire programmé pour ce cancer du sein (+/- tumorectomie)
    3) Abord axillaire électif
    4) Age supérieur ou égal à 18 ans
    5) Etat général (OMS) : 0, 1 ou 2
    6) Bilans hématologique et hépatique satisfaisants:
    Polynucléaires neutrophiles supérieurs ou égal à 1.0 x109/L, plaquettes supérieurs ou égal à 100 x109/L,
    Bilirubine totale inférieure ou égale à 2 x LSN, ASAT (SGOT) et ALAT (SGPT) inférieurs ou égal à 3 x LSN (si métastase hépatique inférieurs ou égal à 5 x LSN), PAL inférieure ou égal à 5 x LSN
    7) Consentement éclairé, daté et signé.
    E.4Principal exclusion criteria
    1) Axillary node dissection associated with a mastectomy
    2) Metastatic Disease
    3) Psychiatric illness disrupting understanding of the trial and the informed and voluntary consent
    4) Pregnancy, breastfeeding
    5) Patient can not submit to monitoring protocol for psychological, social, family or geographical reasons.
    6) Known hypersensitivity to octreotide
    7) Processing ciclosporin
    8) Patient with uncontrolled diabetes
    9) Patient with vitamin B12 deficiency
    10) Anticoagulant therapy
    11) History of cardiovascular disease
    12) Other product being tested in the four weeks preceding the start of treatment
    13) A person who is not affiliated to a system of social security or receiving such a plan
    14) Patient under guardianship or private guardianship of freedom
    1) Curage axillaire associé à une mastectomie
    2) Maladie métastatique
    3) Maladie psychiatrique perturbant la compréhension de l'essai et le caractère éclairé et volontaire du consentement
    4) Grossesse, allaitement
    5) Patiente ne pouvant se soumettre au suivi protocolaire pour des raisons psychologiques, sociales, familiales ou géographiques.
    6) Hypersensibilité connue à l’octréotide
    7) Traitement en cours par ciclosporine
    8) Patiente présentant un diabète non contrôlé
    9) Patiente présentant une carence en vitamine B12
    10) Traitement anticoagulant
    11) Antécédents de troubles cardiovasculaires
    12) Autre produit en cours d’expérimentation dans les 4 semaines précédant le début de traitement
    13) Personne qui n’est pas affiliée à un régime de la sécurité sociale ou bénéficiaire d’un tel régime
    14) Patiente sous tutelle curatelle ou privée de liberté
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the occurrence frequency of a lymphorrhea requiring at least one punction
    Le critère d’évaluation principal sera la fréquence de survenue d’un lymphocèle ayant nécessité au moins une ponction évacuatrice.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 month
    2 mois
    E.5.2Secondary end point(s)
    The secondary endpoints will be:
    - The volume of punctures performed,
    - The frequency and intensity (NCI-CTCAE v4.0) of adverse events,
    - The quality of life score with the FACT-B questionnaire followed at 1 month and 6 months compared to baseline,
    - Medico-economic study will be made according to the Health Insurance (the cost of injection punctures (Act) and the associated transport costs (distance and means of transport)).
    Les critères d’évaluation secondaires seront :
    - le volume des ponctions réalisées,
    - la fréquence et l’intensité (NCI-CTCAE v4.0) des évènements indésirables,
    - le score de qualité de vie obtenu avec le questionnaire FACT-B aux suivis à 1 mois et 6 mois par rapport à l’inclusion,
    - l’étude médico-économique sera faite selon l’Assurance Maladie (le coût de l’injection, des ponctions (acte) ainsi que le coût des transports associés (distance et moyen de transport)).
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 month
    6 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    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 state67
    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 Decision2016-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-25
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