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    Summary
    EudraCT Number:2004-002371-16
    Sponsor's Protocol Code Number:D6997C00002 (9238IL/0064)
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-12-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2004-002371-16
    A.3Full title of the trial
    A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study
    Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™)
    500 mg with Fulvestrant (FASLODEX™) 250 mg in Postmenopausal
    Women with Oestrogen Receptor Positive Advanced Breast Cancer
    Progressing or Relapsing after Previous Endocrine Therapy
    A.4.1Sponsor's protocol code numberD6997C00002 (9238IL/0064)
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameFaslodex 250 mg/5 ml solution for injection
    D.3.2Product code EU/1/03/269/0001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfulvestrant
    D.3.9.1CAS number 129453-62-8
    D.3.9.2Current sponsor codeZD9238
    D.3.9.3Other descriptive nameICI 182780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal women with advanced breast cancer, progressing or relapsing after previous endocrine therapy
    MedDRA Classification
    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 the efficacy of fulvestrant 500 mg treatment with fulvestrant 250 mg treatment in terms of time to progression (TTP)
    E.2.2Secondary objectives of the trial
    To compare fulvestrant 500 mg treatment with fulvestrant 250 mg treatment in terms of the following parameters:
    1. Objective Response rate (ORR) (defined by RECIST criteria)
    2. Clinical Benefit Rate
    3. Duration of response (DoR)
    4. Duration of clinical benefit (DoCB)
    5. Overall survival (OS)
    6. Frequency and severity of adverse events
    7. Quality of Life (QoL)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of written informed consent

    2. Histological/cytological confirmation of breast cancer

    3. Documented positive oestrogen receptor status (ER +ve) of primary or metastatic
    tumour tissue, according to the local laboratory parameters.

    4. Requiring hormonal treatment, defined as either:
    - Relapsing during, or within 12 months of completion of, adjuvant endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane)
    - Progressing on an endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane) given as first
    treatment for patients with de novo advanced breast cancer (defined as metastatic disease or locally advanced disease which is not amenable to treatment with curative intent)
    - Progressing on an endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane) provided that
    this endocrine treatment was started at least 12 months after the completion of adjuvant endocrine treatment

    5. Patients fulfilling one of the following criteria:
    - Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20mm with conventional technique or as ïgreater than or equal to 10 mm with spiral CT scan or MRI
    - Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria

    6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following
    criteria:

    - Age greater than or equal to 60 years.
    - Age greater than or equal to 45 years with amenorrhoea of at least 12 months with an intact uterus.
    - Having undergone a bilateral oophorectomy.
    - FSH and oestradiol levels in postmenopausal range (utilising ranges from
    the testing laboratory facility).
    - In patients who have previously been treated with an LH-RH analogue,
    the last depot must have been administered more than 4 months prior to
    randomisation, menses must not have restarted, and FSH and oestradiol
    levels must also be in the postmenopausal range (utilising ranges from the
    testing laboratory facility).

    7. WHO performance status 0, 1 or 2.

    For inclusion in the translational research component of the study, patients must fulfil the following criteria:

    1. Provision of informed consent for translational research component
    If a patient declines to participate in the translational research component of the
    study, there will be no penalty or loss of benefit to the patient. The patient will not
    be excluded from other aspects of the study described in this Clinical Study
    Protocol, so long as they consent.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:

    1. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or
    present), or symptomatic pulmonary lymphangitic spread. Patients with discrete
    pulmonary parenchymal metastases are eligible, provided their respiratory function
    is not compromised as a result of disease.

    2. More than one regimen of chemotherapy for advanced disease. Note: Patients previously treated with one regimen of chemotherapy for advanced disease are allowed as long as their last treatment is an anti-oestrogen or an aromatase inhibitor.

    3. More than one regimen of endocrine therapy for advanced disease. Note: Oophorectomy, ovarian ablation, or LH-RH analogue therapy do not count as endocrine treatments in this context and also do not render the patient ineligible for
    this study.

    4. Extensive radiation therapy within the last 4 weeks (greater than or equal to 30%
    marrow or whole pelvis or spine) or cytotoxic treatment within the past 4 weeks
    prior to screening laboratory assessment, or strontium-90 (or other radiopharmaceuticals) within the past 3 months.

    5. Treatment with a non-approved or experimental drug within 4 weeks before
    randomisation.

    6. Current or prior malignancy within previous 3 years (other than breast cancer or
    adequately treated basal cell or squamous cell carcinoma of the skin or in-situ
    carcinoma of the cervix).

    7. Any of the following laboratory values:
    - Platelets < 100 x 10E9 / L
    - Total bilirubin > 1.5 x ULRR
    - ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases

    8. History of:
    - bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting
    factor deficiency), or
    - long-term anticoagulant therapy (other than antiplatelet therapy and low dose
    warfarin).

    9. History of hypersensitivity to active or inactive excipients of fulvestrant and/or
    castor oil.

    10. Any severe concomitant condition which makes it undesirable for the patient to
    participate in the trial or which would jeopardize compliance with the trial protocol.
    e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for this study is time to progression (TTP), which is defined as the time from randomization to the time of the earliest objective disease progression, including death from any cause.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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
    500 mg cohort (2 x 5ml dose active) vs 250 mg cohort (1 x 5ml dose active + 1 x 5 ml dose placebo)
    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
    The formal analysis for TTP will be carried out when at least 632 progression events have been observed. When at least 50% of patients have died, subject to regulatory confirmation, the study may be closed following analysis of the survival data and no further study data will be collected. Patients still receiving randomised treatment at this time will be transferred to open-label supplies until disease progression.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    women of greater than or equal to 45 years with an intact uterus and at least 12 months amenorrhoea
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 720
    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 still receiving randomised treatment at the time of study closure will be transferred to open-label supplies until disease progression.
    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 Decision2005-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
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