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    Summary
    EudraCT Number:2011-005334-20
    Sponsor's Protocol Code Number:MO28047
    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:2012-08-02
    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 number2011-005334-20
    A.3Full title of the trial
    A multicenter, open-label, single-arm study of pertuzumab in combination
    with trastuzumab and a taxane in first line treatment of patients with
    HER2- positive advanced (metastatic or locally recurrent) breast cancer
    Studio multicentrico, in aperto, a braccio singolo sull'uso di Pertuzumab in associazione a Trastuzumab e a un taxano nel trattamento di prima linea di pazienti con tumore mammario HER 2 -positivo avanzato(metastatico o recidivato localmente)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, open-label, single-arm study of pertuzumab in combination
    with trastuzumab and a taxane in first line treatment of patients with
    HER2- positive advanced (metastatic or locally recurrent) breast cancer
    Studio multicentrico, in aperto, a braccio singolo di eprtuzumab in associazione a trastuzumab e a un taxano nel trattamento in prima linea di pazienti con tumore mammario HER 2 -positivo avanzato(metastatico o recidivato localmente)
    A.3.2Name or abbreviated title of the trial where available
    PERUSE
    PERUSE
    A.4.1Sponsor's protocol code numberMO28047
    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 Ltd.
    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 pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20052
    B.5.3.4CountryItaly
    B.5.4Telephone number+390392475070
    B.5.5Fax number+390392475085
    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 namePertuzumab (rhuMAb 2C4)
    D.3.2Product code RO 4368451/F01
    D.3.4Pharmaceutical form Concentrate for 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 INNPERTUZUMAB
    D.3.9.1CAS number 380610-27-5
    D.3.9.2Current sponsor codeRO4368451
    D.3.9.4EV Substance CodeSUB16455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420
    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
    Advanced breast cancer (metastatic or locally recurrent)
    Tumore mammario avanzato (metastatico o recidivato localmente)
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer
    Tumore mammario avanzato
    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 evaluate the safety and tolerability of pertuzumab in combination with trastuzumab and a taxane.
    Valutare la sicurezza e la tollerabilità di pertuzumab in associazione a trastuzumab e a un taxano.
    E.2.2Secondary objectives of the trial
    To evaluate pertuzumab in combination with trastuzumab and a taxane
    with respect to:
    •Progression-free survival (PFS)
    •Overall survival (OS)
    •Overall response rate (ORR)
    •Clinical benefit rate (CBR)
    •Duration of response
    •Time to response
    •Quality of life (Functional Assessment of Cancer Therapy- Breast
    [FACT-B] questionnaire for female patients only).
    • Valutare l'uso di pertuzumab in associazione a trastuzumab e a un taxano in termini di:
    • Sopravvivenza libera da progressione (PFS)
    • Sopravvivenza globale (OS)
    • Tasso di risposta globale (ORR)
    • Tasso di beneficio clinico (CBR)
    • Durata della risposta
    • Tempo alla risposta
    • Qualità della vita (questionario Functional Assessment of Cancer Therapy-Breast [FACT-B] solo per le pazienti di sesso femminile).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent approved by the relevant
    Institutional Review Board (IRB), or Independent Ethics Committee
    (IEC).
    2. Male or female patients aged 18 years or over.
    3. Histologically or cytologically confirmed and documented
    adenocarcinoma of the breast with metastatic or locally recurrent
    disease not amenable to curative resection.
    4. HER2-positive (defined as either IHC 3+ or in situ hybridization [ISH]
    positive) as assessed by local laboratory on primary tumor and/or
    metastatic site if primary tumor not available (ISH positivity is defined
    as a ratio of 2.0 or greater for the number of HER2 gene copies to the
    number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4).
    5. At least one measurable lesion and/or non-measurable disease
    evaluable according to Response Evaluation Criteria in Solid Tumors
    (RECIST) version 1.1 (Appendix 5).
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
    or 2 (Appendix 3).
    7. LVEF of at least 50%.
    8. Negative serum pregnancy test in women of childbearing potential
    (WOCBP; premenopausal or less than 12 months of amenorrhea postmenopause,
    and who have not undergone surgical sterilization).
    9. For WOCBP and male patients with partners of CBP who are sexually
    active, agreement to use a highly effective, non-hormonal form of
    contraception (such as surgical sterilization) or two effective forms of
    non-hormonal contraception (such as a barrier method of contraception
    in conjunction with spermicidal jelly) during and for at least 6 months
    post-study treatment (refer to Section 4.5.2.1 for details).
    10. Life expectancy of at least 12 weeks.
    1. Firma del modulo di consenso informato approvato dal comitato etico indipendente (CEI) competente.
    2. Pazienti di ambo i sessi di età ≥ 18 anni.
    3. Adenocarcinoma della mammella istologicamente o citologicamente confermato e documentato, con malattia metastatica o recidivata localmente che non può essere sottoposta a resezione curativa.
    4. Positività a HER-2 (definita come punteggio dell'esame immunoistochimico [IHC] 3+ o positività all'esame di ibridazione in situ [ISH]) del tumore primario e/o del sito metastatico, se non è disponibile un campione del tumore primario, secondo quanto stabilito da un laboratorio locale (la positività ISH è definita da un rapporto di 2,0 o maggiore del numero di copie di geni HER-2 rispetto al numero di segnali CEP17 oppure, per i test a sonda singola, da una conta dei geni HER-2 superiore a 4).
    5. Almeno una lesione misurabile e/o malattia non misurabile valutabile in base ai Criteri di valutazione della risposta nelle neoplasie solide (RECIST), versione 1.1.
    6. Punteggio del performance status secondo l'Eastern Cooperative Oncology Group (ECOG) di 0, 1 o 2.
    7. Frazione di eiezione del ventricolo sinistro (LVEF) almeno del 50%.
    8. Test di gravidanza sul siero negativo nelle donne potenzialmente fertili (in premenopausa o in menopausa con amenorrea da meno di 12 mesi, non sottoposte a sterilizzazione chirurgica).
    9. Per i pazienti sessualmente attivi (donne potenzialmente fertili e uomini con partner potenzialmente fertili), disponibilità a utilizzare una forma di contraccezione non ormonale altamente efficace (quale la sterilizzazione chirurgica) o due forme efficaci di contraccezione non ormonale (quale metodo di barriera in associazione a gel spermicida) durante il trattamento in studio e per almeno 6 mesi dopo la sua interruzione (per informazioni dettagliate consultare il paragrafo 4.5.2.1 del protocollo di studio).
    10. Aspettativa di vita di almeno 12 settimane.
    E.4Principal exclusion criteria
    1. Previous systemic non-hormonal anticancer therapy for the metastatic
    or locally recurrent disease.
    2. Disease-free interval from completion of adjuvant or neoadjuvant
    systemic non-hormonal treatment to recurrence within 6 months.
    3. Previous approved or investigative anti-HER2 agents in any breast
    cancer treatment setting, except trastuzumab and/or lapatinib in the
    adjuvant or neoadjuvant setting.
    4. Disease progression while receiving trastuzumab and/or lapatinib in
    the adjuvant or neoadjuvant setting.
    5. History of persistent Grade 2 or higher (National Cancer Institute
    [NCI]-Common Toxicity Criteria [CTC], Version 4.0) hematological
    toxicity resulting from previous adjuvant or neoadjuvant therapy.
    6. Radiographic evidence of central nervous system (CNS) metastases as
    assessed by computed tomography (CT) or magnetic resonance imaging
    (MRI).
    7. Current peripheral neuropathy of Grade 3 or greater (NCI-CTC,
    Version 4.0).
    8. History of other malignancy within the last 5 years prior to 1st study
    drug administration (dosing), except for carcinoma in situ of the cervix
    or basal cell carcinoma.
    9. Serious uncontrolled concomitant disease that would contraindicate
    the use of any of the investigational drugs used in this study or that
    would put the patient at high risk for treatment-related complications.
    10. Inadequate organ function, evidenced by the following laboratory
    results:
    •Absolute neutrophil count <1,500 cells/mm3
    •Platelet count <100,000 cells/mm3
    •Hemoglobin <9 g/dL
    •Total bilirubin greater than the upper limit of normal (ULN; unless the
    patient has documented Gilbert's syndrome)
    •Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase
    (ALT [SGPT]) >2.5 × ULN (> 5 × ULN in patients with liver metastases)
    •Alkaline phosphatase levels > 2.5 × the ULN (> 5 × ULN in patients
    with liver metastases, or >10 × ULN in patients with bone metastases)
    •Serum creatinine >2.0 mg/dL or 177 μmol/L
    •International normalized ratio (INR) and activated partial
    thromboplastin time or partial thromboplastin time (aPTT or PTT) >1.5 ×
    ULN (unless on therapeutic anti-coagulation).
    11. Uncontrolled hypertension (systolic >150 m m Hg and/or
    diastolic >100 mm Hg) or clinically significant (i.e. active)23cardiovascular disease: cerebrovascular accident/stroke or myocardial
    infarction within 6 months prior to first study medication, unstable
    angina, congestive heart failure (CHF) of New York Heart Association
    (NYHA) Grade II or higher, or serious cardiac arrhythmia requiring
    medication.
    12. Current known infection with HIV, Hepatitis B virus, or Hepatitis C
    virus.
    13. Dyspnea at rest due to complications of advanced malignancy, or
    other disease requiring continuous oxygen therapy.
    14. Major surgical procedure or significant traumatic injury within 28
    days prior to 1st study drug administration (dosing) or anticipation of
    need for major surgery during the course of study treatment.
    15. Receipt of intravenous antibiotics for infection within 14 days prior
    to enrolment.
    16. Current chronic daily treatment with corticosteroids (dose equivalent
    to or greater than 10 mg/day methylprednisolone), excluding inhaled
    steroids.
    17. Known hypersensitivity to any of the study medications or to
    excipients of recombinant human or humanized antibodies.
    18. History of receiving any investigational treatment within 28 days prior to 1st study drug administration (dosing).
    1.Precedente terapia antineoplastica sistemica e non ormonale per la malattia metastatica o recidivata localmente.
    2.Intervallo libero da malattia dal completamento della terapia sistemica non ormonale, adiuvante o neoadiuvante, alla recidiva inferiore a 6 mesi.
    3.Precedenti agenti anti-HER-2, approvati o sperimentali, per il trattamento del tumore mammario in qualsiasi contesto, eccetto trastuzumab e/o lapatinib nel contesto adiuvante o neoadiuvante.
    4.Progressione della malattia in corso di terapia con trastuzumab e/o lapatinib nel contesto adiuvante o neoadiuvante.
    5.Anamnesi di tossicità ematologica persistente di grado 2 o superiore (NCI-CTC, versione 4.0) derivante da precedente terapia adiuvante o neoadiuvante.
    6.Evidenza radiografica di metastasi a carico del sistema nervoso centrale (SNC), rilevate tramite tomografia computerizzata (TC) o risonanza magnetica (RM).
    7.Neuropatia periferica di grado ≥ 3 (Criteri comuni di tossicità [CTC] del National Cancer Institute [NCI], versione 4.0).
    8.Anamnesi di altre neoplasie manifestatesi nei 5 anni precedenti la prima somministrazione del farmaco in studio, ad eccezione di carcinoma cervicale in situ o carcinoma a cellule basali.
    9.Grave patologia concomitante non adeguatamente controllata che renderebbe controindicato l'uso di qualsiasi farmaco sperimentale utilizzato in questo studio o che porrebbe il paziente ad alto rischio di sviluppare complicanze correlate al trattamento.
    10.Inadeguata funzione d'organo, attestata dai seguenti risultati di laboratorio:
    •Conta assoluta dei neutrofili &lt; 1.500 cellule/mm3
    •Conta piastrinica &lt; 100.000 cellule/mm3
    •Emoglobina &lt; 9 g/dl
    •Bilirubina totale più elevata del limite superiore della norma (ULN) (a meno che il paziente non presenti una sindrome di Gilbert documentata)
    •Aspartato aminotransferasi (AST [SGOT]) o alanina aminotransferasi (ALT [SGPT]) &gt; 2,5 x ULN (&gt; 5 volte l'ULN in pazienti con metastasi epatiche)
    •Fosfatasi alcalina &gt; 2,5 × ULN (&gt; 5 × ULN nei pazienti con metastasi epatiche, o &gt; 10 × ULN nei pazienti con metastasi ossee)
    •Creatinina sierica &gt;2,0 mg/dl o 177 μmol/l
    •Rapporto internazionale normalizzato (INR) e tempo di tromboplastina parziale attivata (aPTT) o tempo di tromboplastina parziale (PTT) &gt; 1,5 × ULN (eccetto pazienti in terapia anticoagulante)
    11.Ipertensione non adeguatamente controllata (sistolica &gt; 150 mm Hg e/o diastolica &gt;100 mm Hg) o patologia cardiovascolare clinicamente significativa (ossia attiva: accidente cerebrovascolare/ictus o infarto del miocardio nei 6 mesi precedenti la prima somministrazione del farmaco in studio, angina instabile, insufficienza cardiaca congestizia (ICC) di classe NYHA (New York Heart Association) II o superiore, oppure grave aritmia cardiaca che richieda trattamento farmacologico.
    12.Attuale infezione nota da HIV, virus dell'epatite B o dell'epatite C.
    13.Dispnea a riposo dovuta a complicanze di neoplasia maligna allo stadio avanzato o altra patologia che richieda ossigenoterapia continua.
    14.Procedura di chirurgia maggiore o lesione traumatica significativa nei 28 giorni precedenti la prima somministrazione del farmaco in studio oppure necessità prevista di ricorrere a un intervento di chirurgia maggiore durante il trattamento in studio.
    15.Terapia con antibiotici per via endovenosa (EV) per un'infezione nei 14 giorni precedenti l'arruolamento.
    16.Trattamento giornaliero cronico in atto con corticosteroidi (dose equiv. a/maggiore di 10 mg/die di metilprednisolone), con l’esclusione degli steroidi inalatori.
    17.Nota ipersensibilità a uno qualsiasi dei farmaci in studio o agli eccipienti degli anticorpi ricombinanti umani o umanizzati.
    18.Anamnesi di terapia sperimentale di qualsiasi tipo nei 28 giorni precedenti la prima somministrazione del farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of safety and tolerability.
    Valutazione di sicurezza e tollerabilità.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all patients have been followed up for at least 12 months after the
    last patient receives last study treatment (defined as pertuzumab,
    trastuzumab and a taxane), unless they have been lost to follow up,
    withdrawn consent, or died, or if the study is prematurely terminated by
    the Sponsor, whichever occurs first.
    In addition to final analysis, there will be three interim analyses for
    safety reporting and publication of safety and efficacy results,
    approximately after: 350, 700 and 1000 patients.
    Quando tutti i pazienti saranno stati sottoposti a un follow-up di almeno 12 mesi dopo che l'ultimo paziente avrà ricevuto l'ultimo trattamento in studio, eccetto nei casi di perdita al follow-up, revoca del consenso o decesso, oppure di interruzione prematura dello studio da parte dello sponsor, a seconda di quale delle ipotesi si verifichi per prima. Oltre all'analisi finale, sono previste tre analisi ad interim per la segnalazione dei dati sulla sicurezza e la pubblicazione dei dati sulla sicurezza e l'efficacia dopo che saranno stati arruolati circa 350, 700 e 1000 pazienti.
    E.5.2Secondary end point(s)
    Analysis of efficacy
    Analisi di efficacia
    E.5.2.1Timepoint(s) of evaluation of this end point
    When all patients have been followed up for at least 12 months after the
    last patient receives last study treatment (defined as pertuzumab,
    trastuzumab and a taxane), unless they have been lost to follow up,
    withdrawn consent, or died, or if the study is prematurely terminated by
    the Sponsor, whichever occurs first.
    In addition to final analysis, there will be three interim analyses for
    safety reporting and publication of safety and efficacy results,
    approximately after: 350, 700 and 1000 patients.
    Quando tutti i pazienti saranno stati sottoposti a un follow-up di almeno 12 mesi dopo che l'ultimo paziente avrà ricevuto l'ultimo trattamento in studio, eccetto nei casi di perdita al follow-up, revoca del consenso o decesso, oppure di interruzione prematura dello studio da parte dello sponsor, a seconda di quale delle ipotesi si verifichi per prima. Oltre all'analisi finale, sono previste tre analisi ad interim per la segnalazione dei dati sulla sicurezza e la pubblicazione dei dati sulla sicurezza e l'efficacia dopo che saranno stati arruolati circa 350, 700 e 1000 pazienti.
    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 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
    Quality of life
    qualità della vita
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA231
    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
    Algeria
    Argentina
    Brazil
    Canada
    Chile
    China
    Egypt
    European Union
    India
    Indonesia
    Israel
    Japan
    Kuwait
    Lebanon
    Mexico
    Peru
    Philippines
    Qatar
    Russian Federation
    Saudi Arabia
    Singapore
    Turkey
    United Arab Emirates
    Uruguay
    Venezuela, Bolivarian Republic of
    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
    The study will end when all patients have been followed up for at least 12 months after the last patient receives last study treatment (defined as pertuzumab, trastuzumab and a taxane), unless they have been lost to follow up, withdrawn consent, or died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.
    Quando tutti i paz. saranno stati sottoposti a un fw-up di almeno 12 mesi dopo che l'ultimo paz. avrà ricevuto l'ultimo trattamento in studio, eccetto nei casi di perdita al fw-up, revoca del consenso o decesso, oppure di interruzione prematura.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 1260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1091
    F.4.2.2In the whole clinical trial 1500
    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)
    After discontinuation from the study patients will return to standard
    care.
    Dopo il termine dello studio i pazienti ritorneranno alla terapia attualmente utilizzata nella pratica clinica.
    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 Decision2012-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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