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    Summary
    EudraCT Number:2005-005715-22
    Sponsor's Protocol Code Number:D6990C00001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-01-17
    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 number2005-005715-22
    A.3Full title of the trial
    A randomised Phase II Study comparing anastrozole and fulvestrant to an-astrozole for adjuvant treatment of postmenopausal patients with early breast cancer and disseminated tumour cells in bone marrow - ABCSG 21
    A.4.1Sponsor's protocol code numberD6990C00001
    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.2.1.1.1Trade name FASLODEX
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    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
    D.3.2Product code ZD9238
    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 129453-61-8
    D.3.9.2Current sponsor codeZD9238
    D.3.9.3Other descriptive nameICI 182,780
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Arimidex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    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 nameArimidex
    D.3.2Product code ZD1033
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanastrazole
    D.3.9.2Current sponsor codeZD1033
    D.3.9.3Other descriptive nameARIMIDEX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    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 Arimidex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    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 nameArimidex
    D.3.2Product code ZD1033
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanastrazole
    D.3.9.2Current sponsor codeZD1033
    D.3.9.3Other descriptive nameARIMIDEX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 hormone receptor positive early breast cancer
    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
    The primary objective of this study is to compare the frequency of events (i.e., presence of DTC in BM, clinical recurrence and/or death) in patients treated with anastrozole-fulvestrant combination as compared to that in patients treated with anastrozole alone by assessment of the BM status (i.e., the presence or absence of DTC) and the occurrence of clinical recurrences and/or deaths after 12 months (with a diagnostic window of ±3 weeks) of randomised treatment.
    E.2.2Secondary objectives of the trial
    · To assess the safety of the anastrozole-fulvestrant combination (secondary)
    · To assess the frequency of events (presence of DTC, clinical recurrence and / or death) after 24 months of randomised treatment (secondary)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of written informed consent: signed and dated Informed Consent Form prior to commencement of any specific protocol procedures
    2. Histological confirmation (core needle biopsy or tumour excision) of breast can-cer staged (c/p)T1-4a-c N0-3 G1-3 M0
    3. No signs of distant metastasis in
    · Chest X-ray and liver ultrasound (OR chest and abdomen CT scan)
    · Whole body bone scan
    · Medical history and physical examination
    · Routine laboratory evaluation as outlined in section 4.7.2
    4. Documented positive hormone receptor status (ER +ve and/or PgR +ve) of par-affin-embedded primary tumour tissue (core needle biopsy or tumour excision), according to the local laboratory parameters. A positive hormone receptor status in fine needle aspiration may be used for pre-selection of patients for intraopera-tive Screening BM aspiration; a positive hormone receptor status of the tumour excision is required for inclusion in the study.
    5. Postmenopausal woman, defined as a woman fulfilling any one of the following criteria:
    · Age ³ 60 years;
    · Amenorrhoea ³ 12 months with an intact uterus and ≥ 1 intact ovaries;
    · Having undergone a bilateral oophorectomy;
    · For patients with at least one ovary but without a uterus, FSH and estradiol in the postmenopausal range;
    · For patients previously treated with an LHRH antagonist, the last dose must have been 4 months prior to randomisation, menses must not have restarted and FSH and estradiol must be in the postmenopausal range;
    · Patients who have received adjuvant or neoadjuvant chemotherapy must have met one of the above criteria for postmenopausal status prior to that chemotherapy (subgroup for which pregnancy testing might be considered).
    6. WHO performance status 0, 1 or 2.
    7. At Screening Phase (within 28 days prior to randomisation)
    · Physical examination without clinically significant abnormalities
    · Bone marrow aspiration with”DTC-positive” immunocytochemical result
    · Chest X-ray, liver ultrasound, (or CT chest and abdomen) and bone scan without signs of metastatic breast cancer
    · Laboratory requirements (at a clinically relevant time point prior to specific protocol procedures; i.e. for example 3-4 weeks after any preceding anti-tumour treatment, including chemotherapy, neoadjuvant Herceptin therapy):
    o Neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l
    o Total bilirubin < 1 x ULN (except patients with confirmed Gilbert’s syn-drome who may be included in the study)
    o AST (SGOT) and ALT (SGPT) < 1.5x ULN
    o Alkaline phosphatases < 1 x ULN.
    In case of abnormal values, the liver function tests have to be repeated and meet above criteria within 3 days before study treatment.
    o Creatinine ≤ 1.1 x ULN
    8. At randomisation (endocrine treatment should start within the following 7 days)
    · Final disease stage of completely resected pT1-4a-c N0-3 G1-3 M0 breast cancer
    · Positive (ER +ve and/or PgR +ve) hormone receptor status of the formalin-fixed, paraffin-embedded tumour excision / mastectomy.
    E.4Principal exclusion criteria
    1. Inflammatory (pT4d) and / or metastatic breast cancer (M1)
    2. Current or prior malignancy within previous 5 years (other than breast cancer or adequately treated non melanoma skin cancer or in-situ carcinoma of the cervix)
    3. Premenopausal women
    4. Preceding or concurrent systemic antitumour therapy; EXCEPT:
    · Patient had received adjuvant chemotherapy and has a DTC-positive Screening Phase BM aspiration in local anaesthesia up to 8 weeks after but not less than 2 weeks of completion of chemotherapy;
    · Patient had received prior neoadjuvant chemotherapy with or without tras-tuzumab with an incomplete response (e.g.PR, SD, PD) for assessment of hormone-receptor expression of the residual tumour and has a DTC-positive Screening Phase BM aspiration at or after definitive primary surgery up to 8 weeks after but not less than 2 weeks of completion of chemotherapy;
    5. Immunocytochemical BM screening: ”DTC-negative”
    Note: patient is no longer subject of this trial and may enter other clinical trial
    6. Treatment with a non-approved, investigational or experimental drug within 28 days before randomisation
    7. History of bleeding diathesis (i.e., vW syndrome, disseminated intravascular co-agulation [DIC], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin with INR < 2 – see Sec-tion 3.7)
    8. History of hypersensitivity to active or inactive excipients of fulvestrant, aroma-tase inhibitors or castor oil
    9. Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial pro-tocol, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
    10. Involvement in the planning and conduct of the study (applies to ABCSG staff, AstraZeneca staff or staff at the study site)
    11. Previous enrolment or randomisation of treatment in the present study
    E.5 End points
    E.5.1Primary end point(s)
    ·Frequency of events (DTC-positive BM specimens, clinical recurrence, death) af-ter 12 months of randomised treatment
    Frequency of events (DTC-positive BM specimens, clinical recurrence, death) af-ter 24 months of randomised treatment
    Frequency of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 3) grade 3 or 4 Adverse Events (AE), and Serious Ad-verse Events (SAE) after 12 and 24 months of randomised treatment. All adverse events will be recorded.
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 data cut-off for the primary analysis will be approximately 12 months after the last pa-tient has been recruited and this is estimated to be the third quarter of 2008.
    After the data cut-off for the primary analysis, patients will be followed until the data cut-off date of 24 months after the last patient has been recruited. The study will then be closed and the date for this is estimated to be approximately the fourth quarter of 2009.
    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 years3
    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 No
    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 176
    F.4.2.2In the whole clinical trial 176
    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 Decision2006-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-10-22
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