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    Summary
    EudraCT Number:2006-006507-36
    Sponsor's Protocol Code Number:AVF3693g
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-07
    Trial results Removed from public view
    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 number2006-006507-36
    A.3Full title of the trial
    A Phase III Multicenter Randomized Placebo Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer
    STUDIO DI FASE III, MULTICENTRICO, RANDOMIZZATO, CONTROLLATO DA PLACEBO PER VALUTARE L`EFFICACIA E LA SICUREZZA DEL TRATTAMENTO CON BEVACIZUMAB IN COMBINAZIONE CON IL REGIME CHEMIOTERAPICO IN SOGGETTI CON TUMORE METASTATICO DELLA MAMMELLA PRECEDENTEMENTE TRATTATO.
    A.4.1Sponsor's protocol code numberAVF3693g
    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 SponsorGENENTECH , INC
    B.1.3.4CountryUnited States
    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 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 Bevacizumab
    D.2.1.1.2Name of the Marketing Authorisation holderGenetech Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Previously treated metastatic breast cancer
    Tumore metastatico della mammella precedentemente trattato
    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 10006279
    E.1.2Term Breast neoplasm
    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
    The primary objective of the study is to determine the clinical benefit of the addition of bevacizumab to standard chemotherapy for previously treated metastatic breast cancer (MBC), as measured by progression-free survival (PFS), assessed in a two-step, hierarchical manner as described in the Protocol.
    L'obiettivo primario dello studio e' di determinare il beneficio clinico dell'aggiunta del bevacizumab alla chemioterapia standard per il tumore metastatico della mammella (metastatic breast cancer, MBC) precedentemente trattato, determinato come sopravvivenza in assenza di progressione (progression-free survival, PFS), e verificato con modalita' gerarchica come descritto nel Protcollo.
    E.2.2Secondary objectives of the trial
    - To estimate the clinical benefit of the addition of bevacizumab to each chemotherapy regimen, with PFS estimates and confidence limits calculated within each chemotherapy stratum for bevacizumab and placebo
    - To determinate clinical benefit, as measured by objective response rate, duration of objective response,
    one-year survival, and overall survival, of the addition of bevacizumab to standard chemotherapy options compared with standard chemotherapy alone
    - To compare the incidence of toxicity, as measured by selected adverse events(see Protocol section 3.3.3)
    - Stima del vantaggio clinico dell'aggiunta del bevacizumab a ciascun regime chemioterapico,con valutazioni del PFS e limiti di confidenza calcolati all'interno di ogni strato di chemioterapia,per il bevacizumab e il placebo.
    - Determinazione del beneficio clinico,misurato in base alla percentuale di risposta obiettiva,alla durata della risposta obiettiva,alla sopravvivenza a un anno,e sopravvivenza totale,dell'aggiunta del bevacizumab alle opzioni chemioterapiche convenzionali rispetto alla chemioterapia convenzionale da sola.
    - Confronto dell'incidenza di tossicita',determinata in base ad eventi avversi selezionati (si veda Protocollo sez.3.3.3)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria to be eligible for study entry:
    • Signed Informed Consent Form
    • &#8805; 18 years of age
    • Histologically confirmed carcinoma of the breast with measurable or
    non-measurable metastatic disease that has progressed
    Patients with a history of brain metastasis are eligible for study participation
    (U.S. only), as long as their brain metastases have been treated and they have no
    evidence of progression or hemorrhage after treatment and no ongoing requirement
    for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or
    CT scans) during the screening period. CT scan with contrast or MRI scan of the
    brain must be performed at least 3 weeks after completion of all therapy to the brain.
    Treatment for brain metastasis may include the following: WBRT, SRS
    (Gamma knife, LINAC, or equivalent), or a combination as deemed appropriate by
    the treating physician. Radiotherapy and stereotactic radiosurgery must be
    completed at least 4 weeks prior to Day 0.
    Patients may also have neurosurgical resection. Neurosurgery must be completed
    at least 6 weeks prior to Day 0, and brain biopsy must be completed at least
    4 weeks prior to Day 0.
    • Progression of disease during or following administration of one
    (non-investigational) chemotherapy regimen, defined as single-agent
    chemotherapy administered prior to or during disease progression or a
    pre-specified combination or sequence of cytotoxic agents administered in the
    first-line settingSubjects whose initial treatment changed prior to progression in the
    first-line setting are ineligible unless the change occurred within 30 days
    of initial treatment due to toxicity.
    • ECOG performance status of 0 or 1 (see Appendix B)
    • For women of childbearing potential, use of an effective means of
    non-hormonal contraception
    • Life expectancy &#8805; 3 months
    • Willingness and capacity to comply with study and follow-up procedures
    I pazienti dovranno soddisfare tutti i seguenti criteri di inclusione:
    • Firma del Consenso Informato scritto
    • Paziente di eta' &#8805; 18 anni
    • Carcinoma della mammella confermato istologicamente con lesioni metastatiche misurabili o non misurabili che siano in progressione
    • Progressione di malattia durante o dopo la somministrazione di un regime chemioterapico citotossico convenzionale, definito come trattamento con chemioterapia ad agente singolo (single-agent chemotherapy) somministrato prima della progressione della malattia o come combinazione pre-determinata, o sequenza di agenti cito-tossici somministrati nella terapia di prima linea.
    Quei soggetti la cui terapia iniziale e' stata modificata prima della progressione nel corso dell'adattamento terapeutico di prima linea, non sono elegibili per lo studio a meno che tale variazione sia avvenuta entro 30 giorni dall'inizio del trattamento iniziale, per motivi di tossicita'.
    • ECOG tra 0 e 1
    • Per donne in eta' fertile uso di un effettivo metodo di contraccezione non ormonale
    • Aspettativa di vita &#8805; 3 mesi
    • Capacita' di soddisfare le richieste dello studio e le procedure di follow up
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be excluded from study entry:
    a. Disease Treatment History
    • Prior hormonal therapy only as treatment for metastatic disease
    without chemotherapy. Patients must have received chemotherapy for their
    metastatic disease in the first-line setting. Hormone therapy alone is not allowed.
    • For subjects who have received prior anthracycline-based therapy,
    documentation of left ventricular ejection fraction < 50% by either
    multiple gated acquisition (MUGA) or echocardiogram (ECHO)
    • Treatment with more than one prior cytotoxic regimen for MBC
    • HER2-positive status
    In general, HER2-positive status will be identified by a fluorescence in situ
    hybridization (FISH) assay as evaluated at the institution or, if FISH is
    unavailable, a 2+ or 3+ immunohistochemistry result (but the method of
    identification may vary by region or institution). Patients who have unknown
    HER2 status, and for whom determination of HER2 status is not possible,
    are eligible for this study.
    • Unknown ER and PR status
    • Radiation therapy other than for palliation or brain metastasis, biologic therapy,
    or chemotherapy for MBC within 21 days prior to Day 0
    • Prior therapy with bevacizumab or other VEGF pathway-targeted therapy
    See Protocol sec. 4.1.3 for:
    b. Bevacizumab Exclusion Criteria
    c. General Exclusion Criteria
    Soggetti che presentino i seguenti criteri saranno esclusi dalla partecipazione allo studio:

    a. Storia del trattamento della malattia
    • Precedente terapia ormonale solo come trattamento per le metastasi, senza chemioterapia
    • Per soggetti che hanno ricevuto precedente terapia con antracicline, documentazione di frazione di eiezione del ventricolo sinistro &lt; 50% tramite MUGA o ecocardiogramma
    • Trattamento con piu' di un regime citotossico per cancro metastatico della mammella
    • Pazienti con positivita' per HER2
    • Pazienti con status ignoto per recettore degli estrogeni e del progesterone
    • Radioterapia tranne come palliativo o per metastasi cerebrali, terapia biologica o chemioterapia per cancro metastatico della mammella entro 21 giotni prima del giorno 0
    • Precedenti tepapie con bevacizumab o altra terapia VEGF pathway-targeted
    Si veda Protocollo sez. 4.1.3 per:
    b. Criteri di Esclusione per Bevacizumab
    c. Criteri di Esclusione Generali
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival
    Sopravvivenza in Assenza di 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 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia Standard
    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 concerned10
    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
    Tossicita', problemi legati all'arruolamento o ai dati (si veda protocollo sec. 4.7)
    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 months30
    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 months33
    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.1.3Elderly (>=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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 700
    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)
    Terapia Standard
    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 Decision2007-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-06
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