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    Summary
    EudraCT Number:2004-002839-10
    Sponsor's Protocol Code Number:GERICO 04/0406
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2005-02-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-002839-10
    A.3Full title of the trial
    Phase II trial assessing the impact on instrumental and daily living autonomy of a chemotherapy regimen with bi-weekly docetaxel in the treatment of metastatic breast cancer in patients over the age of 70
    A.3.2Name or abbreviated title of the trial where available
    Bi-weekly docetaxel
    A.4.1Sponsor's protocol code numberGERICO 04/0406
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFédération Nationale des Centres de Lutte Contre le Cancer
    B.1.3.4CountryFrance, Metropolitan
    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 Information not present in EudraCT
    D.2.1.1.1Trade name TAXOTERE®
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTAXOTERE®
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdocetaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    HR+ or HR- metastatic adenocarcinoma of the breast with a measurable target (RECIST criteria) in patients aged 70 or over
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version V5
    E.1.2Level LLT
    E.1.2Classification code 10027475
    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 impact of chemotherapy on autonomy of activity in instrumental life, defined according to the IADL index in 8 items during treatment (2nd, 4th and 6th cycle), at 6 and 12 months.
    E.2.2Secondary objectives of the trial
    To assess:
    - Response rate according to RECIST criteria after first line docetaxel administered bi-weekly,
    - Overall survival, progression-free survival,
    - Impact of chemotherapy on autonomy of activity in instrumental life, defined according to ADL index using 6 items,
    - Impact of chemotherapy on mood status according to the Geriatric Depression Scale,
    - Toxicity defined according to the NCI-CTC criteria.

    Proteomics : Patients will be asked to consent to blood sampling for a proteomic study that will evaluate the ability of specific proteomic profiles to predict for response to treatment and toxicities.

    A pharmacokinetic study of docetaxel and its metabolites will be offered to every patient during the first cycle.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Women aged ≥ 70.
    2. Histologically confirmed breast adenocarcinoma.
    3. Metastatic disease measurable by scan or MRI (RECIST criteria).
    4. First-line metastatic chemotherapy (only one line of prior metastatic hormone therapy is allowed). Prior (neo)adjuvant chemotherapy for breast cancer is allowed.
    5. Prior hormone therapy stopped at least 10 days before patient’s enrolment in the study.
    6. Satisfactory autonomy of daily activity: IADL ≥ 4 or ADL ≥ 4.
    7. Satisfactory haematological and hepatic function: Hb >10g/dL, neutrophil count > 1.5x109/L, platelets > 100x109/L, transaminases < 1.5N, bilirubin <1.0N, alkaline phosphatases < 2.5N.
    8. Creatinine clearance > 30 ml/min calculated according to Cokroft's formula.
    9. Signed informed consent.
    10. Life expectancy > 3 months
    E.4Principal exclusion criteria
    1. All patients that do not fulfil the inclusion criteria.
    2. Other serious illness or medical conditions, including:
    - Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from trial entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
    - History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent
    - Active uncontrolled infection
    - Active peptic ulcer, uncontrolled diabetes mellitus, inflammatory bowel disease
    3. Concurrent treatment with any other anti-cancer therapy: trastuzumab, other chemotherapy or hormone therapy. Bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed.
    4. Patients having a history of treatment by trastuzumab.
    5. Patients having a history of treatment by taxanes (docetaxel or paclitaxel) within the two (2) years from trial entry.
    6. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< ou = 20 mg methylprednisolone per day or equivalent).
    7. Definite contraindications for the use of corticosteroids.
    8. Past or current history of neoplasm other than breast carcinoma, except:
    - Curatively treated non-melanoma skin cancer
    - in situ carcinoma of the cervix
    - Other cancer curatively treated and with no evidence of disease for at least 5 years
    9. Patients having a GDS (geriatric depression scale) score ≥ 12.
    10. History of hypersensitivity to docetaxel or drugs formulated in polysorbate 80.
    11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up; Incapacity for undergoing regular checks.
    12. Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry.
    13. Male subject.
    E.5 End points
    E.5.1Primary end point(s)
    To assess :

    - the percentage of patients that maintain their autonomy in all instrumental activities of daily living as defined in the IADL assessment scale, in 8 items during treatment (2nd, 4th and 6th cycle), at 6 and 12 months.

    - the response rate according to RECIST criteria after first line docetaxel administered bi-weekly
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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
    autonomy of activity in instrumental life (IADL)
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    inclusion period : 12 months
    treament period : 24 weeks
    post treament follow-up : up to 1 year
    duration of the trial : 2 years
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 58
    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 Decision2005-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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