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    Summary
    EudraCT Number:2012-005337-37
    Sponsor's Protocol Code Number:ONC-2012-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-03-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-005337-37
    A.3Full title of the trial
    ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY + GnRH ANALOGUE
    Ruolo dell’Ormone Antimülleriano (AMH) quale marcatore della riserva ovarica in giovani donne affette da carcinoma mammario operabile e candidate a chemioterapia in concomitanza con LH-RH analogo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY
    Ruolo dell’Ormone Antimülleriano (AMH) quale marcatore della riserva ovarica in giovani donne affette da carcinoma mammario operabile e candidate a chemioterapia
    A.4.1Sponsor's protocol code numberONC-2012-002
    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 SponsorIstituto Clinico Humanitas
    B.1.3.4CountryItaly
    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 supportIPSEN
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportServizio Sanitario Nazionale
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEMMEDI Srl divisione Solaris
    B.5.2Functional name of contact pointDirezione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street Addressvia C. Poma, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20129
    B.5.3.4CountryItaly
    B.5.4Telephone number00390276115147
    B.5.5Fax number0039027491855
    B.5.6E-mailregulatory@solaris-italy.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 Decapeptyl
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDecapeptyl
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELIN
    D.3.9.1CAS number 57773-63-4
    D.3.9.4EV Substance CodeSUB11324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    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
    Female subjects, aged <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.
    Donne di età inferiore ai 40 anni, con carcinoma mammario operabile, candidate a chemioterapia adiuvante, che riceveranno LH-RH analogo in concomitanza alla chemioterapia a scopo di gonadoprotezione.
    E.1.1.1Medical condition in easily understood language
    Female subjects, aged <40 years, with diagnosis of operable breast cancer candidates to receive adjuvant chemotheraphy for 4-8 cycles
    Donne di età inferiore ai 40 anni con carcinoma mammario operabile e che possono ricevere terapia adiuvante
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006203
    E.1.2Term Breast cancer stage unspecified
    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 evaluate AMH levels changes in response to chemotherapy plus GnRHa in order to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa
    Studiare la variazione di AMH in corso di chemioterapia + LH-RH analogo per valutare il ruolo di AMH quale marcatore dell’effetto gonadoprotettivo dell’LH-RH analogo.
    E.2.2Secondary objectives of the trial
    a) to correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);
    b) to compare AMH levels obtained at the end of chemotherapy and at 12 months after the end of chemotherapy in the two cohorts of ER positive and ER negative patients
    c) the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point.
    a) Correlare il comportamento di AMH con il recupero del ciclo mestruale (nella coorte ER-ve)
    b) Confrontare i livelli di AMH alla fine della chemioterapia e dopo 12 mesi dalla fine della chemioterapia nelle 2 coorti di pazienti ER+ve ed ER-ve.
    c) Valutare dopo 12 mesi la percentuale di pazienti con livelli di AMH > 0.2 ng/mL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Female subjects, aged <40yr at the time of breast cancer diagnosis
    2) Diagnosis of operable breast cancer any T and N, any ER
    3) Patients candidate to adjuvant chemotherapy for 4-8 cycles.
    4) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the start of the study treatment.
    5) Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy
    1) Donne di età < 40 anni all’epoca della diagnosi del carcinoma mammario.
    2) Pazienti con carcinoma mammario operabile, di qualsiasi grado T, N e ER
    3) Pazienti candidate a chemioterapia adiuvante per 4-8 cicli
    4) Funzione midollare, renale ed epatica nella norma, in seguito a valutazione tramite i relativi esami di laboratorio, che dovranno essere eseguiti entro 28 giorni prima dell’inizio del trattamento.
    5) Le donne potenzialmente fertili devono avere eseguito un test di gravidanza negativo e devono accettare di utilizzare un metodo contraccettivo molto efficace

    E.4Principal exclusion criteria
    1) Presence of distant metastasis
    2) Clinically significant cardiovascular disease
    3) Psychological or social conditions which might affect study compliance
    4) Unstable neurologic function
    e) Patients with known allergy to any of the components of the study medication
    5) Pregnancy or lactation
    1) Presenza di metastasi a distanza
    2) Patologie cardiache significative
    3) Condizioni psicologiche o sociali che potrebbero avere conseguenze sulla fattibilità dello studio
    4) Disfunzione neurologica
    5) Donne in stato di gravidanza (β-hCG test positivo) o in corso di allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The principal endpoint is the proportion of breast cancer women < 40 yrs with a percent change or Δ ≤ 50% of AMH levels at 12 months after chemotherapy as compared with basal levels.
    L’endpoint dello studio è rappresentato dalla proporzione di pazienti che hanno una riduzione di AMH a 12 mesi dal termine della chemioterapia ≤ 50% rispetto al valore basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    a) to correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);
    b) to compare AMH levels obtained at the end of chemotherapy and at 12 months after the end of chemotherapy in the two cohorts of ER positive and ER negative patients
    c) the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point;
    d) In centres with reproductive gynaecologic facilities, the antral follicle count (AFC) ,which is considered as a reliable marker of ovarian reserve will be determined at baseline and at the 12-month time point in the ER negative cohort
    a) Correlare il comportamento di AMH con il recupero del ciclo mestruale (nella coorte ER-ve)
    b) Confrontare i livelli di AMH alla fine della chemioterapia e dopo 12 mesi dalla fine della chemioterapia nelle 2 coorti di pazienti ER+ve ed ER-ve.
    c) Valutare dopo 12 mesi la percentuale di pazienti con livelli di AMH > 0.2 ng/mL
    d) Nei centri con unità di ginecologia riproduttiva, nella coorte ER-, verrà determinato il numero di follicoli antrali (AFC) a 12 mesi rispetto al basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 Yes
    E.6.4Safety Yes
    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 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 concerned5
    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
    LSLV
    LSLV
    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 months2
    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: 80
    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 state80
    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)
    The long term menstrual and reproductive history should be collected in all participants as long as possible, including regular menses, age at menopause and pregnancies.
    Per tutti le partecipanti dovranno essere raccolti i dati a lungo termine relativi alla regolarità delle mestruazioni, l’ età di insorgenza della menopausa e le gravidanze.
    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 Decision2013-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-25
    P. End of Trial
    P.End of Trial StatusOngoing
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