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    Summary
    EudraCT Number:2007-006060-29
    Sponsor's Protocol Code Number:FARM6N78KN
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-29
    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 number2007-006060-29
    A.3Full title of the trial
    Efficacy and toxicity of Trastuzumab at the maintaining dose of 1 mg/kg/week versus the standard dose of 2 mg/kg/week in combination with chemotherapy in metastatic breast cancer patients. A phase III multicenter study.
    Efficacia e tossicita` di Trastuzumab alla dose di mantenimento di 1 mg/kg/settimana verso la dose convenzionale di 2 mg/kq/settimana in associazione alla chemioterapia nel tumore della mammella metastatico. Studio multicentrico di fase III.
    A.3.2Name or abbreviated title of the trial where available
    Dose optimization of Trastuzumab
    GIM-7 DOT
    A.4.1Sponsor's protocol code numberFARM6N78KN
    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 SponsorIST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 HERCEPTIN*EV 1FL 150MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrastuzumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    HER-2 positive metastatic breast cancer
    Carcinoma mammario metastatico HER-2 positivo
    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 PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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
    to compare efficacy in terms of Progression Free Survival (PFS) of Trastuzumab at the maintaining dose of 1 mg/kg/week or 3 mg/kg/q3w vs the standard dose of 2 mg/kg/week or 6 mg/kg/q3w in metastatic breast cancer patients with HER-2 overexpressing tumors and candidates for first line treatment with chemotherapy associated with Trastuzumab
    confrontare in termini di sopravvivenza libera da progressione l'efficacia del Trastuzumab alla dose di mantenimento di 1mg/kg settimanale e di 3 mg/kg ogni 3 settimane verso la dose standard di 2mg/kg settimanale e di 6 mg/kg ogni 3 settimane nelle pazienti con carcinoma mammario metastatico HER-2 positivo candidate ad una prima linea di trattamento con chemioterapia e Trastuzumab.
    E.2.2Secondary objectives of the trial
    to compare
    a) Overall Survival (OS)
    b) Overall Response Rate (ORR)
    c) Toxicity
    d) Cardiotoxicity (Appendix 2)
    e) Pharmacokinetic (Appendix 1) between the two study arms
    confrontare la sopravvivenza globale,il tasso di risposte,la tossicita',la cardiotossicita' e la farmacocinetica.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOECONOMIC:
    Vers:
    Date:
    Title:
    Objectives:

    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:
    Date:
    Title:
    Objectives:

    LIFE QUALITY:
    Vers:
    Date:
    Title:
    Objectives:
    FARMACOECONOMIA:
    Vers:
    Data:
    Titolo:
    Obiettivi:

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:
    Data:
    Titolo:
    Obiettivi:

    QUALITA DELLA VITA:
    Vers:
    Data:
    Titolo:
    Obiettivi:
    E.3Principal inclusion criteria
    1. Female gender
    2. Age > 18 years
    3. ECOG Performance Status 0-1 (Appendix II)
    4. Histological diagnosis of breast cancer with evidence of metastatic or recurrent disease. Lesions should not be amenable to surgery or radiation for curative intent.
    5. Baseline LVEF &#8805; 50 measured by echocardiography or MUGA scan
    6. Overexpression of HER2 (Appendix IV)
    7. Indication to treatment with chemotherapy + Trastuzumab.
    8. Previous hormonal therapy for both adjuvant and metastatic disease is allowed.
    9. Previous adjuvant and/or neo-adjuvant chemotherapy is allowed
    10. Previous Trastuzumab therapy for adjuvant treatment is allowed
    10. Estimated life expectancy of at least 12 weeks.
    11. Adequate bone marrow, liver and renal function.
    12. Signed written informed consent obtained prior to study screening procedures.
    13. Patients with reproductive potential must use an approved contraceptive method if appropriate (except hormonal substitutive therapy) during and for 3 months after stopping treatment.
    1. Sesso femminle
    2. Eta' &gt; 18 anni
    3. ECOG Performance Status 0-1
    4. Diagnosi istologica di carcinoma mammario con evidenza di malattia metastatica o recidiva. Le pazienti non dovrebbero essere candidate a chirurgia o radioterapia con intento curativo.
    5. LVEF basale &#8805; 50 valutata con ecocardiogramma o MUGA
    6. Iperespressione di HER-2
    7. Indicazione a trattamento con Trastuzumab + chemioterapia
    8. E' consentita precedente ormonoterapia
    9. E' consentita precedente chemioterapia adiuvante e/o neoadiuvante
    10. E' consentita precedente terapia adiuvante con Trastuzumab
    11. Aspettativa di vita di almeno 12 settimane
    12. Adeguata funzionalita' epatica, renale e midollare
    13. Consenso informato scritto firmato
    14. Le pazienti in eta' fertile devono usare un adeguato metodo contraccettivo (eccetto terapia ormonale sostitutiva) durante e fino a 3 mesi dopo la sospensione del trattamento.
    E.4Principal exclusion criteria
    1. Past or current history of malignant neoplasms except for curatively treated ones. The following malignant neoplasms if curatively treated, do not preclude patient inclusion: basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix, any cancer that has been curatively treated, with no evidence of disease, and a <15% risk of recurrence over the next 10 years, previous ductal carcinoma in situ of the breast
    2. Prior use of anti-HER2 therapy for metastatic disease
    3. Prior chemotherapy for metastatic disease
    4. Concurrent anti-cancer treatment with an investigational drug.
    5. Concurrent serious medical condition or cardiac illness or severe pulmonary conditions/illness. Serious cardiac illness which lead to patient exclusion (ineligible) include but are not confined to :
    a. History of documented congestive heart failure (CHF)
    b. High-risk uncontrolled arrhythmias
    c. Angina pectoris requiring antianginal medication
    d. Clinically significant valvular heart disease
    e. Evidence of transmural infarction on ECG
    f. Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic greater than 100mm Hg)
    6. Pregnant or lactating women
    7. Patients with clinical evidence of symptomatic brain metastasis
    1. Storia di neoplasia maligna presente o pregressa ad eccezione di quelle trattate con intento curativo. Le seguenti neoplasie, se trattate con intento curativo, non escludono l'arruolamento: carcinoma basocellulare e squamocellulare, carcinoma in situ della cervice uterina, qualsiasi neoplasia trattata con intento curativo, senza evidenza di malattia, un rischio di ricorrenza nei successivi 10 anni &lt; 15% e pregresso carcinoma mammario duttale in situ.
    2. Precedenti terapie anti-HER2 per malattia metastatica
    3. Concomitante trattamento antineoplastico con altri farmaci oggetto di studio
    4. Gravi patologie concomitanti polmonari o cardiache. Le patologie cardiache che implicano l'esclusione delle pazienti comprendono:
    - Storia di scompenso cardiaco documentato
    - Altro rischio di aritmie non controllate
    - Angina pectoris in trattamento
    - Patologie valvolari cardiache clinicamente significative
    - Evidenza di infarto transmuralle all'ECG
    - Ipertensione non controllata (e.g. sistolica &gt;180mmHg o diastolica &gt;100 mmHg)
    - Donne in gravidanza o allattamento
    - Pazienti con evidenza clinica di metastasi cerebrali sintomatiche
    E.5 End points
    E.5.1Primary end point(s)
    Time to progression
    Tempo alla progressione
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial2
    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 concerned39
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 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 state750
    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 Decision2008-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-12-21
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