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    Summary
    EudraCT Number:2005-004247-54
    Sponsor's Protocol Code Number:D6997C00006 (9238IL/0068)
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-004247-54
    A.3Full title of the trial
    A Randomised, Double-blind, Parallel-group, Multicentre, Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 250 mg, Fulvestrant (FASLODEX™) 250 mg (plus 250 mg Loading regimen) and Fulvestrant (FASLODEX™) 500 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy
    A.4.1Sponsor's protocol code numberD6997C00006 (9238IL/0068)
    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 AuthorisationBelgium
    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 codeD6997C00006 (9238IL/0068)
    D.3.9.3Other descriptive nameICI 182,780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250/5
    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 Information not present in EudraCT
    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 oestrogen receptor (ER) positive advanced breast cancer who have either relapsed whilst on adjuvant endocrine therapy, or progressed whilst on first endocrine therapy for advanced disease, or who have had recurrent disease within 12 months after completion of adjuvant 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 evaluate the objective response rate (ORR) of patients treated with fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg.
    E.2.2Secondary objectives of the trial
    1. To estimate the pharmacokinetic characteristics of fulvestrant in patients treated with fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg by measuring Cmax, Clearance and Volume of distribution at steady state.
    2. To evaluate the efficacy of fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg treatment in terms of time to progression (TTP).
    3. To evaluate the clinical benefit rate (CBR) of patients treated with fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg.
    4. To evaluate the duration of response (DoR) in patients treated with fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg.
    5. To assess the tolerability of fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg by adverse events, safety clinical laboratory tests and vital signs, electrocardiogram and physical examination.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of informed consent
    2. Histological/cytological confirmation of breast cancer (from either primary or metastatic tumour)
    3. Documented positive oestrogen receptor status (ER +ve) of primary or metastatic tumour tissue, defined as ≥10% positive staining by Immunohistochemistry (IHC)
    4. Requiring hormonal treatment:
    · Relapsing during, or within 12 months of completion of, adjuvant endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane)*, or
    · 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, or
    · 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**
    *Use of more than one agent in the adjuvant setting is acceptable.
    **Advanced breast cancer: Metastatic disease or locally advanced disease which is not amenable to treatment with curative intent.
    5. Patients with measurable disease as per RECIST criteria. This is defined as at least one targeted lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional technique or as ≥ 10 mm with spiral CT scan.
    6. Postmenopausal women are defined as those women fulfilling any 1 of the following criteria:
    · Age ≥ 60 years.
    · Having undergone a bilateral oophorectomy.
    · Age < 60 years with an intact uterus and at least one intact ovary, amenorrhoea ≥12 months continuous AND
    - If they received systemic cytotoxic anti-cancer therapy
    - The last dose must have been > 12 months prior to randomisation or
    - Age > 45 years
    - If they were on an LHRH analogue the last depot must have been administered > 4 months prior to randomisation and FSH and oestradiol levels must be in the post menopausal range.
    · For patients with at least one intact ovary and prior history of hysterectomy: FSH and oestradiol levels must be in the post menopausal range AND
    - If they received systemic cytotoxic anti-cancer therapy
    - The last dose must have been > 12 months prior to randomisation or
    - Age > 45 years
    - If they were on an LHRH analogue the last depot must have been administered > 4 months prior to randomisation.
    7. WHO performance status 0, 1 or 2.
    E.4Principal exclusion criteria
    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 clinically and significantly compromised as a result of disease.
    2. More than one previous regimen of systemic anti-cancer therapy other than endocrine treatment for advanced disease.
    Note: Patients previously treated with one regimen of systemic anti-cancer therapy other than endocrine treatment for advanced disease are allowed as long as their last treatment is an anti-oestrogen or an aromatase inhibitor
    3. More than one previous 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 4 weeks prior to randomisation (greater than or equal to 30% marrow or whole pelvis or spine) or systemic anti-cancer therapy other than endocrine treatment within 4 weeks prior to randomisation, or radiolabelled strontium (or other radiopharmaceuticals) within 12 weeks prior to randomisation.
    5. Treatment with a non-approved or experimental drug except the post-manufacturing/marketing clinical study 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 within 3 weeks prior to randomisation:
    · Platelets < 100 ´ 109 / L
    · Total bilirubin > 1.5 ´ ULRR*
    · ALT or AST > 2.5 ´ ULRR if no demonstrable liver metastases or > 5 ´ ULRR in presence of liver metastases
    * Patients with confirmed Gilbert’s syndrome may be included in the study
    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 – see Section 3.7).
    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.
    11. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    12. Previous enrolment or randomisation of treatment in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Recruitment is expected to be completed by 15th October 2007.
    The study will be analysed when all patients, except withdrawals, have been followed up for at least 24 weeks. The data will be reviewed in order to allow the continued supply of randomised treatment to those patients receiving clinical benefit.
    Since in this study the study treatment will be continued until the progression of disease, the occurrence of an intolerable AE, its discontinuation requested by a subject or required for other reasons, or the completion of the whole study, it is difficult to clearly set the time of study completion. For this reason, the completion time has been set at April 2008
    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 No
    E.8.1.1Randomised Yes
    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 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 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
    Treatment will continue until disease progression, unless any of the criteria for treatment discontinuation are met.
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 135
    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 Decision2006-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-13
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