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    Summary
    EudraCT Number:2005-004001-29
    Sponsor's Protocol Code Number:D8664C00008
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-15
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2005-004001-29
    A.3Full title of the trial
    An Open Label, Randomised, Parallel Group, Multicentre Study to
    Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks with ZOLADEX
    3.6 mg Given Every 4 Weeks in Pre-menopausal Women with Oestrogen
    Receptor Positive Advanced Breast Cancer
    A.4.1Sponsor's protocol code numberD8664C00008
    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 Yes
    D.2.1.1.1Trade name Zoladex LA 10.8 mg implant
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca UK Ltd.
    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.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGoserelin
    D.3.9.3Other descriptive name(as Goserelin acetate)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.8
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.2.1.1.1Trade name Zoladex 3.6 mg Implant
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca UK Ltd.
    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.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGoserelin
    D.3.9.3Other descriptive name(as Goserelin acetate)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Oestrogen receptor (ER) positive advanced breast cancer (ABC) in pre-menopausal women
    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 evaluate whether ZOLADEX 10.8 mg is non-inferior to ZOLADEX 3.6 mg in pre-menopausal women with oestrogen receptor (ER) positive advanced breast cancer (ABC) by assessment of progression-free survival (PFS) at 24 weeks.
    E.2.2Secondary objectives of the trial
    • To provide supportive data confirming that ZOLADEX 10.8 mg every 12 weeks is
    non-inferior to ZOLADEX 3.6 mg every 4 weeks by assessment of:
    − Objective response rate (ORR) at 24 weeks, with response defined as complete
    or partial response as determined by Response Evaluation Criteria In Solid
    Tumours (RECIST) criteria
    − Oestradiol (E2) serum concentrations at 24 weeks
    • To compare the safety and tolerability profile of ZOLADEX 10.8 mg and
    ZOLADEX 3.6 mg by assessment of adverse events (AEs)
    • To assess goserelin PK in Japanese and Caucasian patients who have received
    ZOLADEX 10.8 mg by assessment of goserelin plasma concentration-time profiles.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic assessments
    E.3Principal inclusion criteria
    Provision of written informed consent
    − For the PK analyses in this study (see Section 4.5), optional additional blood
    samples will be taken from those patients who provide written informed
    consent to confirm that they are willing to participate in this part of the study.
    This consent will be in addition to their written informed consent to confirm
    their willingness to participate in the main study. See Section 8.3.1 for further
    information
    2. Female ≥18 years and pre-menopausal
    − Pre-menopausal defined as 1) last menses within 1 year of administration of
    study drug, and 2) E2 ≥10 pg/mL and FSH ≤30 mIU/mL within 4 weeks of
    administration of study drug. For patients who have had a hysterectomy, it is
    acceptable to meet only criterion 2.
    3. Histological/cytological confirmation of locally advanced or metastatic breast
    cancer and are candidates to receive hormonal therapy as therapy for advanced
    disease. Patients may have received prior adjuvant chemotherapy, radiotherapy or
    hormonal therapy for EBC
    4. Documented evidence of hormone sensitivity (ER positive) of primary or secondary
    tumour tissue
    5. World Health Organization (WHO) Performance status of 0, 1 or 2 (see Appendix D)
    6. At least one measurable lesion (not located in a previously irradiated area) according to RECIST with the exception of patients with bone metastases only or complete remission after prior taxane- or anthracycline based first line chemotherapy for ABC (stage IV). See Section 3.3.3, exclusion criterion 4, for further details of eligibility criteria concerning prior first line chemotherapy for ABC.
    Patients with bone metastases only must fulfil one of the following conditions:
    - Have osteolytic lesions identifiable by bone x-ray (patients with productive bone lesions only, as identified by bone x-ray, are not eligible),
    - Have bone lesions identified by MRI or computed tomography scan (patients with productive bone lesions only, as identified by MRI or computed tomography scan, are eligible).
    Patients with complete remission after prior taxane- or anthracycline based first line chemotherapy for ABC must fulfil one of the following conditions:
    - Have had at least one measurable lesion (not located in a previously irradiated area) according to RECIST prior to taxane- or anthracycline based first line chemotherapy for ABC,
    - Have had bone metastases meeting the criteria listed above prior to taxane- or anthracycline based first line chemotherapy for ABC.

    E.4Principal exclusion criteria
    1. Patients who have received tamoxifen or other hormonal therapies as adjuvant
    therapy for EBC in the 24 weeks before administration of study drug; prior treatment with hormonal therapies for ABC
    2. Patients who have received LHRHa as adjuvant therapy for EBC in the 48 weeks
    before administration of study drug (up to 2 years of adjuvant treatment with an
    LHRHa is permitted)
    3. Patients who have received any radiotherapy for EBC or ABC within 4 weeks before administration of study drug
    4. Prior first line chemotherapy for ABC with the exception of taxane- or
    anthracycline-based chemotherapy providing that a) there is no evidence of
    progressive disease since the start of the chemotherapy and b) the patient has
    pre-menopausal status after starting chemotherapy. Patients who have had prior
    chemotherapy for ABC must have had at least one menstrual period since starting
    chemotherapy. Any taxane- or anthracycline-based chemotherapy must be
    completed at least 4 weeks prior to Day 1 of this study. (Prior adjuvant
    chemotherapy for EBC is allowed except when it has been administered within 4 weeks before study drug administration )
    5. Prior treatment with herceptin for EBC within 4 weeks before study drug administration; prior treatment with herceptin for ABC
    6. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic
    involvement, or any degree (proven or suspected) of brain or leptomeningeal
    involvement (past or present) or symptomatic pulmonary lymhangitic spread.
    Patients with discrete pulmonary parenchymal metastases are eligible, provided
    their respiratory function is not compromised as a result of disease
    7. Estimated survival less than 24 weeks from the start of study therapy (Day 1) based on clinical judgment
    8. History (within previous 3 years before administration of study drug) of systemic
    malignancy other than breast cancer with the exception of basal cell/squamous cell
    carcinoma of the skin or cancer of the cervix that has been satisfactorily controlled
    9. Platelets <100x109/L; total bilirubin >1.5x upper limit of reference range (ULRR);
    alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5xULRR if
    no demonstrable liver metastases or >5xULRR in presence of liver metastases
    10. Any other significantly abnormal laboratory test result at baseline that would place the patient at unusual risk or confound the results of the study as assessed by the treating investigator
    11. Treatment with a non-approved or experimental drug within the preceding 12 weeks before administration of study drug
    12. Patients with a relevant history of any severe concomitant disease that would place the patient at unusual risk or confound the results of the study (eg, a strong family history of osteoporosis or severe renal or hepatic impairment) as assessed by the treating investigator
    13. Patients who, for whatever reason (eg, confusion, infirmity, alcoholism) are
    unlikely to comply with study requirements as assessed by the treating investigator
    14. Patients considered by the investigator to be at risk of transmitting any infection
    through blood or other body fluids including the agents for acquired immune
    deficiency syndrome or other sexually transmitted disease or hepatitis
    15. History of bleeding diathesis (ie, disseminated intravascular coagulation or clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet
    therapy and low dose warfarin)
    16. History of any hypersensitivity to active or inactive excipients of ZOLADEX or
    tamoxifen
    17. Pregnancy or breast feeding
    18. Patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop
    19. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study centre)
    20. Previous enrolment or randomisation of treatment in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study variable measurement is disease progression. The primary outcome variable is the Progression Free Survival; this is used as the basis for the sample size calculations
    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 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 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) 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.8.5.1Number of sites anticipated in the EEA21
    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 No
    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
    Last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 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) No
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 98
    F.4.2.2In the whole clinical trial 260
    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)
    Post study medication is at the discretion of the investigator.
    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 Decision2006-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-18
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