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    Summary
    EudraCT Number:2013-001981-40
    Sponsor's Protocol Code Number:ICO-N-2013-03
    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:2014-04-16
    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 number2013-001981-40
    A.3Full title of the trial
    Pilot feasibility study of fertility preservation by ovarian stimulation associated with tamoxifen and oocyte or embryo freezing prior chemotherapy for breast cancer.
    Etude pilote de faisabilité de PReservation de la fErtilité par Stimulation ovarienne associée à du tAmoxifène et conGElation ovocytaire ou embryonnaire avant chimiothérapie pour cancer du sein.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot feasibility study of fertility preservation by ovarian stimulation associated with tamoxifen and oocyte or embryo freezing prior chemotherapy for breast cancer.
    Etude pilote de faisabilité de préservation de la fertilité par stimulation ovarienne associée à du tamoxifène et congé-lation ovocytaire ou embryonnaire avant chimiothérapie pour cancer du sein.
    A.3.2Name or abbreviated title of the trial where available
    PRESAGE
    A.4.1Sponsor's protocol code numberICO-N-2013-03
    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 CANCEROLOGIE 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 CANCEROLOGIE 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 CANCEROLOGIE DE L'OUEST
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard Jacques Monod
    B.5.3.2Town/ citySAINT HERBLAIN
    B.5.3.3Post code44805
    B.5.3.4CountryFrance
    B.5.4Telephone number+33240679747
    B.5.5Fax number+33240679787
    B.5.6E-maildrci@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 NOLVADEX
    D.2.1.1.2Name of the Marketing Authorisation holderAZTRAZENECA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNOLVADEX
    D.3.2Product code RVG 09592
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAMOXIFEN
    D.3.9.1CAS number 10540-29-1
    D.3.9.4EV Substance CodeSUB10825MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    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.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
    Invasive breast cancer in women under 40 years
    Cancer du sein infiltrant chez la femme de moins de 40 ans
    E.1.1.1Medical condition in easily understood language
    Invasive breast cancer in women under 40 years
    cancer du sein infiltrant chez la femme de moins de 40 ans
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    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
    Evaluate the feasibility of combining tamoxifen ovarian stimulation to recombinant FSH and oocyte vitrification and / or embryo freezing prior chemotherapy for breast cancer.
    Evaluer la faisabilité d’une stimulation ovarienne associant le Tamoxifène à de la FSH recombinante puis vitrification ovocytaire et/ou congélation embryonnaire avant chimiothérapie pour cancer du sein.
    E.2.2Secondary objectives of the trial
    -Estimate the average time before the start of chemotherapy
    -Assess the impact of the type of stimulation on the number and quality of oocytes and / or embryos collected (phase of the cycle at the beginning of stimulation)
    Check-impact of ovarian stimulation procedure on recurrence and survival for 5 years
    -Determine the number of pregnancies
    -Descriptive analysis of the above parameters in women who accepted the preservation of fertility
    ­-Evaluer le délai moyen avant le début de la chimiothérapie
    -Evaluer l’impact du type de stimulation sur le nombre et la qualité des ovocytes et/ou des embryons recueillis (phase du cycle au début de stimulation)
    -Vérifier impact de la procédure de stimulation ovarienne sur la récidive et sur la survie pendant 5 ans
    -Evaluer le nombre de grossesses
    -Analyse descriptive des précédents paramètres chez des femmes ayant accepté la préservation de fertilité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Obtention signed informed consent before any specific procedure to test
    2.Age between 18 and 40 years
    3.Carcinome histologically proven infiltrating breast
    4.Indication adjuvant or neoadjuvant chemotherapy validated pretreatment RCP
    5.T0-T1-T2-T3
    6.N0-N1-N2a
    7.M0 after staging according to the recommendations of the INCA
    8.Statut BRCA indifferent
    9.AMH ≥ 1 ng / mL and / or ≥ 5 CFA (ultrasound: punctionable ovaries transvaginal)
    10.sérologie negative HIV
    social 11.Protection
    1.Obtention du consentement éclairé signé avant toute procédure spécifique à l’essai
    2.Age compris entre 18 et 40 ans
    3.Carcinome mammaire infiltrant prouvé histologiquement
    4.Indication de chimiothérapie adjuvante ou néoadjuvante validée en RCP pré-thérapeutique
    5.T0-T1-T2-T3
    6.N0-N1-N2a
    7.M0 après bilan d’extension selon les recommandations de l’INCA
    8.Statut BRCA indifférent
    9.AMH ≥1 ng/mL et/ou CFA ≥ 5 (à l’échographie : ovaires ponctionnables par voie transvaginale),
    10.sérologie HIV négative
    11.Protection sociale
    E.4Principal exclusion criteria
    1.Antécédents Breast Cancer
    2.Antécédent other cancer in the last five years, with the exception of skin cancer basal cell and squamous cell
    Loading 3.Grossesse
    Pulmonary 4.Embolie less than 6 months
    Deep vein 5.Thrombose less than 6 months
    6.Démence or altered mental status
    7.Incapacité legal or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent (Article L.1121-6-8 L.1211, L.1211-9).
    1.Antécédents de cancer du sein
    2.Antécédent d’autre cancer dans les 5 dernières années, à l’exception des cancers cutanés baso-cellulaires et spino-cellulaires
    3.Grossesse en cours
    4.Embolie pulmonaire de moins de 6 mois
    5.Thrombose veineuse profonde de moins de 6 mois
    6.Démence ou état mental altéré
    7.Incapacité légale ou capacité légale limitée. Conditions médicales ou psychologiques ne permettant pas au sujet de comprendre l’étude et signer le consentement (art. L.1121-6, L.1211-8, L.1211-9).
    E.5 End points
    E.5.1Primary end point(s)
    the number of oocytes and / or embryos per patient included
    le nombre d’ovocytes et/ou d’embryons obtenus par patiente incluse
    E.5.1.1Timepoint(s) of evaluation of this end point
    2.5 years after the beginning of the inclusions (2 years for inclusions and 6 months to recover the data)
    2,5 ans après le début des inclusions (2 ans d'inclusion et 6 mois pour récupérer les données)
    E.5.2Secondary end point(s)
    - Time in days between the day of consultation with the oncologist and the day of the first treatment
    - Number of positive beta hCG and number of clinical pregnancies achieved
    - Evaluation of survival and recurrence for 5 years
    - Descriptive analysis of parameters in women with accepted conservation and fertility
    ­- délai en jours entre le jour de la consultation avec l’oncologue et le jour de l’administration du premier traitement
    ­- nombre de béta hCG positifs et nombre de grossesses cliniques obtenues
    - évaluation de la survie et la récidive pendant 5 ans
    - analyse descriptive des paramètres chez les femmes ayant accepté la préservation de fertilité
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end or study ; after 5 ans of follow up, after recovering all data

    à la fin de l'étude, au bout des 5 ans de suivi et après récupération de l'ensemble des données
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility Study
    Etude de faisabilité
    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
    last visit of the last patient included
    dernière visite de la dernière patiente incluse
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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) Yes
    F.1.2.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state100
    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)
    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 Decision2013-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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