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    Summary
    EudraCT Number:2004-003617-16
    Sponsor's Protocol Code Number:D6997C00003 (9238IL/0065)
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-19
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-003617-16
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Fulvestrant (FASLODEX™) 250 mg when given as Neoadjuvant Treatment in Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0)
    A.3.2Name or abbreviated title of the trial where available
    NEWEST – Neoadjuvant Endocrine therapy for Women with Estrogen Sensitive Tumors
    A.4.1Sponsor's protocol code numberD6997C00003 (9238IL/0065)
    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 Österreich GmbH
    B.1.3.4CountryAustria
    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.2.1.1.1Trade name Faslodex 250 mg/5 ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0)
    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 effects of fulvestrant 500 mg and fulvestrant 250 mg on the proliferation marker Ki67 at 4 weeks
    E.2.2Secondary objectives of the trial
    Compare effects of fulvestrant 500 mg and 250 mg on:
    - the down-regulation of ER and PgR expression
    - proliferation marker Ki67
    - clinical, radiological and pathological tumor responses
    Correlate response after 16 weeks of treatment to biological correlates detected after 4 and 16 weeks of treatment
    Compare the actual surgery performed
    Compare the effects of fulvestrant 500 mg and 250 mg on:
    - endometrial thickness and uterine dimensions
    - serum bone markers
    Assess:
    - correlation between changes in Ki67 LI and changes in ER and PgR expression
    - pharmacokinetics of fulvestrant
    - relationship between the pharmacokinetics markers (AUC, Cmax) and dynamic markers of downregulation and proliferation
    Compare the tolerability of fulvestrant 500 mg with that of fulvestrant 250 mg
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of written informed consent.
    2. Histologically/cytologically confirmed invasive breast cancer, ER positive as defined by the local laboratory
    3. Operable or potentially operable locally advanced tumor (T2, 3, 4b, N0-3, M0). The largest diameter of the tumor as measured by ultrasound or by MRI must be ³ 2 cm. Patients with two measurable nodules will be eligible as long as both lesions are biopsied and have similar histology and are both ER positive.
    4. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
    · Age ³ 60 years
    · Age ³ 45 years with amenorrhea ³ 12 months with an intact uterus
    · Having undergone a bilateral oophorectomy
    · FSH and estradiol levels in postmenopausal range (utilizing ranges from the testing laboratory facility).
    5. Willingness to undergo biopsy at baseline and at 4 weeks and surgery at 16 weeks
    6. WHO performance status 0, 1 or 2
    For inclusion in the genetic component of the study, patients must fulfill the following criteria:
    1. Provision of informed consent for genetic sampling and analyses
    If a patient declines to participate in the genetic 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
    1. Inoperable due to satellite skin nodules or true inflammatory carcinoma.
    2. Multifocal disease (> 2 major tumor nodules). Patients with more than one primary tumor will be excluded.
    3. Presence of metastatic disease as defined by the American Joint Committee on Cancer (AJCC) guidelines revised in 2002 (Singletary, 2002). Metastatic evaluation should be performed according to the usual guidelines of the institutions. It is recommended that the following evaluations should be done:
    · Chest X-ray
    · Liver function tests
    · CBC with differential cell count and platelet count.
    · Abdominal CT scan if liver function tests significantly elevated
    · CT scan of the chest and abdomen for clinical stage ³ T3, or > N1
    · Bone scan if bony discomfort, elevated serum alkaline phosphatase, ³ T3 or >N1 clinical disease
    · Bilateral mammograms
    4. Any previous treatment for breast cancer
    5. Unwillingness to stop taking any drug known to affect sex hormonal status (including HRT), or a patient in whom it would be inappropriate to stop
    6. Current or prior malignancy within previous 3 years (other than adequately treated basal cell or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix)
    7. Any of the following laboratory values:
    · Platelets < 100 ´ 109 / L
    · Total bilirubin > 1.5 ´ ULRR
    · ALT or AST > 2.5 ´ ULRR
    8. Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus
    9. Patients known to be HIV, hepatitis B or C positive are not eligible because of the potential to confound the study endpoints, although patients will not be routinely screened for HIV, hepatitis B or C
    10. History of :
    · bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
    · long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin – see Section 3.7)
    11. History of hypersensitivity to castor oil
    12. Treatment with a non-approved or experimental drug within 4 weeks before randomization
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Comparison of fulvestrant 250 mg and 500 mg by measuring tumour markers at 4 and 16 weeks

    Pharmacokinetics and Safety
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison of two doses, 250 mg and 500 mg of fulvestrant
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months6
    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) 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 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 age ³ 45 years with amenorrhea ³ 12 months with an intact uterus will be included in the trial
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 160
    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 Decision2004-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-09
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