Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35887   clinical trials with a EudraCT protocol, of which   5891   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005328-17
    Sponsor's Protocol Code Number:MO28048
    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:2012-03-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005328-17
    A.3Full title of the trial
    A PHASE III PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER [SafeHer Study]
    STUDIO DI FASE III PROSPETTICO, A DUE COORTI, NON RANDOMIZZATO, MULTICENTRICO, INTERNAZIONALE, IN APERTO, VOLTO A VALUTARE LA SICUREZZA DI TRASTUZUMAB PER VIA SOTTOCUTANEA, IN SOMMINISTRAZIONE ASSISTITA E AUTO-SOMMINISTRAZIONE, COME TERAPIA ADIUVANTE IN PAZIENTI AFFETTI DA TUMORE MAMMARIO IN FASE INIZIALE, HER-2-POSITIVO,OPERABILE [Studio SafeHer]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A TWO-ARM, NON-RANDOMIZED, MULTICENTER, MULTINATIONAL, OPEN-LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED-AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE Her2-positive early breast cancer
    STUDIO PER VALUTARE LA SICUREZZA DELLA SOMMINISTRAZIONE ASSISTITA O DELL'AUTOSOMMINISTRAZIONE DI TRASTUZUMAB SOTTOCUTE COME TERAPIA ADIUVANTE IN PAZIENTI CON TUMORE MAMMARIO IN FASE INIZIALE, OPERABILE
    A.3.2Name or abbreviated title of the trial where available
    SafHer Study
    Studio SafHer
    A.4.1Sponsor's protocol code numberMO28048
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche S.p.A.
    B.5.2Functional name of contact pointEthics & Administrative Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressViale G. B. Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number++39-039-247 5070
    B.5.5Fax number++39-039-246 5117
    B.5.6E-mailitaly.info_cta@roche.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 No
    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 nameHerceptin for SC injection
    D.3.2Product code Ro 045-2317/F07
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRo 045-2317/F07
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Yes
    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 RoleComparator
    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 No
    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 nameHerceptin for SC injection
    D.3.2Product code Ro 045-2317/F06
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRo 045-2317/F07
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Yes
    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
    HER2-positive primary breast cancer
    Tumore della mammella in fase iniziale HER2-positivo operabile
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Tumore della mammella
    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 10065430
    E.1.2Term HER-2 positive breast cancer
    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 assess the overall safety and tolerability of subcutaneous (SC) trastuzumab in HER2-positive early breast cancer (EBC) patients with assisted administration using a conventional syringe and needle (vial formulation) and with assisted administration with or without selfadministration using a single-use injection device (SID).
    Valutare la sicurezza complessiva e la tollerabilità di trastuzumab per via sottocutanea (SC) nel tumore mammario in fase iniziale (EBC, Early Breast Cancer) HER-2-positivo, in somministrazione assistita mediante siringa e ago convenzionali (formulazione in flaconcino) e in somministrazione assistita con o senza auto-somministrazione mediante un dispositivo di iniezione monouso (SID, Single-Use Device).
    E.2.2Secondary objectives of the trial
    • Efficacy (both cohorts): - disease-free survival (DFS) - overall survival (OS) • Patient satisfaction with trastuzumab SC administration using the SID (patients in Cohort B who went on to self-administration of the study drug).
    Valutazione dei seguenti parametri: •Efficacia (entrambe le coorti) o Sopravvivenza libera da malattia (DFS, Disease-Free Survival) oSopravvivenza globale (OS, Overall Survival •Soddisfazione dei pazienti relativa alla somministrazione SC di trastuzumab mediante SID (pazienti della Coorte B passati all'auto-somministrazione del farmaco in studio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent approved by the reviewing independent Ethics Committee (EC) 2. Female or male aged 18 years or above 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I (T1, N0, M0) to IIIC (any T, N3, M0) that is eligible for adjuvant treatment with trastuzumab Note: Patients treated without neoadjuvant or adjuvant chemotherapy, such as patients with low risk node negative tumours ≤ 1.0 cm, elderly patients (>65 years of age) or patients with HER2-positive EBC but denying chemotherapy, will also be eligible to participate in the study, but their enrolment will be limited to approximately 10% of the total study population. 5. HER2-positive EBC, defined as IHC 3+, or FISH/CISH positive, as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay 6. Screening left ventricular ejection fraction (LVEF) ≥ 55% as measured by echocardiography, Multi Gated Acquisition (MUGA) scan or Magnetic Resonance Imaging (MRI) per local practice 7. Agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential (defined as pre-menopausal and not surgically sterilized or < 1 year after the onset of menopause) and by male participants with partners of childbearing potential only. 8. Intact skin at site of SC injection on the thigh.
    1.Consenso informato scritto, approvato dal Comitato etico indipendente pertinente 2.Pazienti di ambo i sessi di età ≥ 18 anni 3.Punteggio del performance status secondo l'Eastern Cooperative Oncology Group (ECOG) di 0 o 1. 4.Carcinoma mammario invasivo in fase iniziale HER-2-positivo confermato istologicamente senza evidenza di malattia residua, recidivata localmente o metastatica, e classificato come stadio clinico da I (T1, N0, M0) a IIIC (qualsiasi T, N3, M0), idoneo al trattamento adiuvante con trastuzumab. NB: anche i pazienti trattati non sottoposti a chemioterapia neoadiuvante o adiuvante, ad esempio i pazienti con tumori a basso rischio con linfonodi negativi di dimensione ≤ 1,0 cm, i pazienti anziani (&gt; 65 anni) o i pazienti con EBC HER-2-positivo che rifiutano la chemioterapia, potranno partecipare allo studio, ma il loro arruolamento dovrà essere limitato al 10% circa della popolazione in studio totale. 5.EBC HER-2-positivo, definito da un punteggio IHC di 3+ o dalla positività alla FISH/CISH, secondo quanto stabilito da un laboratorio locale con comprovata esperienza/certificazione nel test di espressione di HER-2, utilizzando un saggio preciso e validato. 6.Valore di screening della frazione di eiezione ventricolare sinistra (LVEF) ≥ 55% secondo le misurazioni effettuate mediante ecocardiogramma, scansione MUGA o risonanza magnetica (RM), secondo la prassi locale. 7.Consenso a utilizzare adeguati metodi non ormonali di contraccezione da parte dei partecipanti di sesso femminile potenzialmente fertili (in pre-menopausa e non sottoposte a sterilizzazione chirurgica oppure con &lt; 1 anno dall'insorgenza della menopausa) e dei partecipanti di sesso maschile con partner potenzialmente fertili. Esempi di metodi contraccettivi adeguati sono dispositivo intrauterino, metodo di barriera (preservativo, diaframma), in associazione a gel spermicida, o astinenza totale. I contraccettivi ormonali orali, iniettabili o impiantabili non sono ritenuti metodi contraccettivi accettabili per le pazienti partecipanti allo studio. 8.Cute integra al punto dell'iniezione SC sulla coscia.
    E.4Principal exclusion criteria
    Cancer related Criteria:1. Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent 2. History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively-treated malignancies who have been disease-free for at least 5 years, are eligible. 3.Past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) that has been treated with any systemic therapy OR with radiation therapy to the ipsilateral breast where invasive cancer subsequently develops. Patients who had their DCIS/LCIS treated with surgery only are allowed to enter the study. 4.Metastatic disease Haematological, Biochemical and Organ Function: 5.Inadequate bone marrow function (as indicated by any of the following): o Total white blood cell count (WBC) < 2,500 / mm3 (<2.5 x 109/L) o Absolute neutrophil count (ANC) < 1,500 / mm3 (< 1.5 x 109/L) o Platelets < 100,000 / mm3 (< 100 x 109/L) o Haemoglobin < 10 g/dL 6. Impaired hepatic function (as indicated by any of the following): o Serum total bilirubin > 1.5 x upper limit of normal (ULN) o Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) >1.25 x ULN o Alkaline phosphatase (ALP) >2.5 x ULN 7. Impaired renal function, as indicated by serum creatinine > 1.5 x ULN Other Study Drug-related Exclusion Criteria: 8. Serious cardiac illness or medical conditions including but not confined to: o History of documented heart failure or systolic dysfunction (LVEF < 50%) o High-risk uncontrolled arrhythmias such as atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular (AV) block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block) o Angina pectoris requiring anti-anginal medication o Clinically significant valvular heart disease o Evidence of transmural infarction on electrocardiogram (ECG) o Poorly controlled hypertension, or history of hypertensive crisis or hypertensive encephalopathy 9. Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness 10.Prior maximum cumulative dose of doxorubicin >360 mg/m2 or maximum cumulative dose of epirubicin >720 mg/m2 or equivalent 11.Known hypersensitivity to trastuzumab, murine proteins, or excipients, or to the adhesive of the SC device 12.History of severe allergic or immunological reactions, e.g. difficult to control asthma. 13.Pregnancy or lactation 14.Unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator 15.Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment 16.Major surgical procedure or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment. Patients must be free of any clinically significant sequalae of prior surgery before they can receive their first dose of study treatment. 17.More than 12 weeks between the end of the last chemotherapy cycle and the first dose of study treatment, in case these treatments are initiated sequentially. This criterion does not apply to patients who are starting trastuzumab SC without previous or concurrent chemotherapy or concurrently with chemotherapy. 18.Current chronic daily treatment with corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids 19.Current peripheral neuropathy of grade 3 or greater per the NCI-CTCAE vers.4.0
    Criteri tumore correlati 1.Prec.trattamento neoadiuvante o adiuvante per ca mammario con agente anti-HER-2 approvato o sperimentale.2.Anamnesi di altra neoplasia che potrebbe compromettere compliance al prot. o interpretazione risultati.Eleggibili paz.con ca cervicale in situ o ca a cellule basali trattati con intento curativo e paz.con altre neoplasie trattate con intento curativo liberi da malattia da almeno 5 anni.Anamnesi di ca duttale in situ(DCIS)e/o ca lobulare in situ(LCIS)trattato con qualsiasi terapia sistemica oppure con radioterapia alla mammella ipsilaterale dove si è successivamente sviluppato il ca invasivo.Ingresso nello studio consentito solo a paz.con pregresso DCIS/LCIS trattato con sola chirurgia.4.Malattia metastatica Criteri ematologici, biochimici e correlati alla funzione d'organo 5.Funzione midollare inadeguata(come da uno dei seguenti valori): •Conta totale leucociti&lt;2.500/mm3(2,5x109/l)•Conta assoluta neutrofili &lt;1.500/mm3 (&lt;1,5x109/l)•Piastrine &lt; 100.000/mm3 (&lt;100x109/l).•Emoglobina &lt;10 g/dl 6.Compromissione della funzione epatica(come da uno dei seguenti valori:•Bilirubina sierica totale &gt;1,5xlimite superiore della norma(ULN)•Alanina aminotransferasi e/o aspartato aminotransferasi &gt;1,25xULN •Fosfatasi alcalina &gt;2,5xULN 7.Compromissione della funzione renale:creatinina sierica&gt;1,5xULN Altri criteri di esclusione correlati al farmaco in studio 8.Gravi patologie cardiache o mediche,incluse a titolo esemplificativo ma non esaustivo le seguenti:•Anamnesi di insufficienza cardiaca o disfunzione sistolica(LVEF&lt;50%)documentate.Aritmie incontrollate ad alto rischio,quali tachicardia atriale con frequenza cardiaca &gt; 100/min a riposo, significativa aritmia ventricolare (tachicardia ventricolare)o blocco AV di grado più elevato (blocco AV di 2°di tipo 2[Mobitz 2]o blocco AV di 3°•Angina pectoris con necessità di terapia farmacologica antiangina•Valvulopatia cardiaca clinicamente significativa •Evidenza infarto transmurale all'ECG•Ipertensione non adeguatamente controllata, o anamnesi di crisi ipertensive o encefalopatia ipertensiva 9.Altre gravi patologie concomitanti che potrebbero interferire con il trattamento pianificato, incluse gravi pneumopatie 10.Prec.dose cumulativa massima di doxorubicina &gt;360 mg/m2 o massima dose cumulativa di epirubicina &gt;720mg/m2 o equivalente 11.Nota ipersensibilità a trastuzumab,proteine murine,eccipienti,oppure all'adesivo dispositivo SC 12.Anamnesi di gravi reazioni allergiche o immunologiche,ad es.asma difficile da controllare Criteri generali di esclusione 13.Gravidanza o allattamento 14.Incapacità o riluttanza ad attenersi ai requisiti del prot., secondo parere dello sperimentatore 15.Arruol.contestuale in altro studio clinico con uso di trattamento antitumorale sperimentale,incluse terapia ormonale,terapia con bifosfonati e immunoterapia, nei 28 giorni precedenti la prima dose del trattamento in studio. 16.Procedura di chirurgia maggiore o lesione traumatica significativa nei 28 giorni precedenti la 1°dose di trattamento in studio,oppure necessità prevedibile di ricorrere a un intervento di chirurgia maggiore durante il trattamento in studio. I paz. non devono presentare sequele clinicamente significative di precedenti interventi chirurgici prima di poter ricevere la prima dose del trattamento in studio. 17.Più di 12 settimane tra la conclusione dell'ultimo ciclo chemioterapico e la 1°dose del trattamento in studio, qualora tali trattamenti fossero avviati sequenzialmente. Tale criterio non si applica ai paz che iniziano la terapia con trastuzumab SC senza precedente o concomitante chemioterapia o contestualmente alla chemioterapia.18.Trattamento giornaliero cronico in atto concorticosteroidi(dose equival. a/&gt;di10 mg/die di metilprednisolone, steroidi inalatori esclusi.19.Concomitante neuropatia periferica in atto di grado 3 o maggiore secondo Criteri(NCI-CTCAE)
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints are the primary objectives in this study and will include: all AEs, Grade ≥3 AEs, SAEs, AEs leading to premature discontinuation of study treatment, AEs causing interruption of trastuzumab SC, cardiac AEs, CHF-related SAEs, premature withdrawals from study and study medication, exposure to treatment, laboratory parameters, LVEF, vital signs, ECG, weight, and ECOG performance status.
    Gli endpoint di sicurezza rappresentano gli obiettivi primari di questo studio e includono: tutti gli AE, AE di grado ≥ 3, SAE, AE che determinano l'interruzione prematura del trattamento in studio, AE che causano l'interruzione di trastuzumab SC, AE cardiaci, AE correlati a ICC, ritiri prematuri dallo studio e dalla terapia con i farmaci in studio, esposizione al trattamento, parametri di laboratorio, LVEF, parametri vitali, ECG, peso e performance status ECOG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of the safety endpoints will take place when all patients have received 18 cycles of trastuzumab SC and have completed the Safety Follow-up assessments (4 weeks after their last dose of study treatment).
    Un'analisi preliminare degli endpoint di DFS e OS sarà condotta al momento delle analisi di sicurezza primarie, ossia quando tutti i pazienti avranno ricevuto 18 cicli di trastuzumab SC e avranno completato le valutazioni di follow-up della sicurezza (4 settimane dopo l'ultima dose del trattamento oggetto di studio). L'analisi finale di OS e DFS sarà condotta quando l'ultimo paziente sarà stato seguito per almeno 24 mesi dopo il suo ultimo trattamento in studio, oppure prima se sarà documentata una delle seguenti evenienze per tutti i pazienti trattati: revoca del consenso, perdita al follow-up o decesso
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include DFS, OS (both cohorts) and patients' satisfaction with trastuzumab SC administration using the SID (Cohort B patients who went on to self administration only).
    End-point secondari di efficacia: sopravvivenza libera da malattia e sopravvivenza complessiva in entrambe le coorti; soddisfazione del paziente nell'utilizzo di trastuzumab sottocute (SC) somministrato tramite dispositivo monouso (SID) (nella coorte B di pazienti, per quei pazienti che sono stati in grado di auto-somministrarsi il farmaco)
    E.5.2.1Timepoint(s) of evaluation of this end point
    A preliminary analysis of DFS and OS will be undertaken at the time of the primary safety analysis, i.e. when all patients have received 18 cycles.
    Un'analisi preliminare della sopravvivenza libera da malattia e sopravvivenza complessiva sarà eseguita al momento della analisi primaria di sicurezza (per esempio quando tutti i pazienti avranno ricevuto i 18 cicli di trattamento)
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Patient satisfaction e Medical Care Utilization
    Immunogenicità, soddisfazione del paziente, utilizzo delle risorse mediche
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned33
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA300
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Albania
    Algeria
    Argentina
    Australia
    Bahrain
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    Colombia
    Croatia
    Dominican Republic
    Ecuador
    Egypt
    El Salvador
    European Union
    Guatemala
    Hong Kong
    India
    Indonesia
    Korea, Republic of
    Kuwait
    Lebanon
    Malaysia
    Mexico
    Moldova, Republic of
    Morocco
    New Zealand
    Pakistan
    Panama
    Peru
    Philippines
    Qatar
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Thailand
    Trinidad and Tobago
    Tunisia
    Turkey
    Ukraine
    United Arab Emirates
    Venezuela, Bolivarian Republic of
    Vietnam
    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 patient last visit in the follow-up. The study will end when all patients have been followed for at least 24 months after their last study treatment, or earlier, if one of the following is documented for all treated patients: withdrawal from the study, loss to follow up or death.
    LVLS nel follow-up. Lo studio terminerà quando tutti i pazienti saranno stati sottoposti a un follow-up di almeno 24 mesi dopo aver ricevuto l'ultima dose del trattamento, o prima,in caso si verifichi per tutti i pazienti trattati:uscita dallo studi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months54
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months54
    E.8.9.2In all countries concerned by the trial 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.1.2.1Number of subjects for this age range: 2200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state188
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1719
    F.4.2.2In the whole clinical trial 2500
    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)
    Patients who discontinue study treatment prematurely due to lack of tolerability will be clinically managed as per local practice and followed as outlined in the Schedule of Assessments, Appendix 1. All prematurely withdrawn patients, who have received at least one dose of trastuzumab, should continue to be monitored for cardiac function as described in the Herceptin SmPC, within or outside the study, as appropriate.
    I pazienti che interromperanno prematuramente il trattamento previsto dallo studio per intolleranza saranno valutati e trattati clinicamente come da pratica clinica e seguiti nel follow-up come precisato nell'Appendice 1 della Schedule of Assessment
    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 Decision2012-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA