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    Summary
    EudraCT Number:2004-003888-71
    Sponsor's Protocol Code Number:CFEM345DDE09
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-003888-71
    A.3Full title of the trial
    An open phase III trial with Letrozole (Femara®) alone or in combination with Zoledronic acid (Zometa®) as extended adjuvant treatment of postmenopausal patients with primary breast cancer
    A.3.2Name or abbreviated title of the trial where available
    EXpANd
    A.4.1Sponsor's protocol code numberCFEM345DDE09
    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 SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    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 Zometa
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameZometa
    D.3.2Product code CGP42446
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZoledronic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    prevention of tumortherapy-induced bone loss
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10049470
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    It is the aim of this study to show superiority of Zoledronic acid in prevention of bone loss, administered in combination with Letrozole as extended adjuvant therapy of postmenopausal women with primary hormone receptor positive breast cancer compared to Letrozole alone.

    Primary efficacy variable:
    Treatment difference in change in BMD measured by DXA in lumbar spine (L1-L4) at 36 months as compared to baseline.
    E.2.2Secondary objectives of the trial
    To compare the combined treatment of Letrozole and Zoledronic acid with Letrozole monotherapy with respect to
    · BMD (measured by DXA at lumbar spine, L1-L4), at 12 months
    · Fracture rate
    · Disease free survival (DFS)
    · Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for the study a patient must fulfill all of the following criteria:
    · Signed informed consent
    · Age > 18 years
    · Performance status 0-2 (ECOG)
    · Compliant postmenopausal women. Postmenopausal is defined as one of
    the following:
    · Age >55 years with cessation of menses.
    · Age <55 but no spontaneous menses for at least 1 year.
    · Age <55 and spontaneous menses within the past 1 year, but currently
    amenorrheic (e.g., spontaneous, or secondary to hysterectomy), and with
    postmenopausal gonadotrophin levels (luteinizing hormone and follicle
    stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels
    (<5ng/dL) or according to the definition of “postmenopausal range” for the
    laboratory involved.
    · Histologically confirmed primary operable breast cancer after 4 to 6 years
    of therapy with Tamoxifen (end of Tamoxifen therapy within last 6 months)
    · Nodal status positive or negative
    · ER and/or PgR positive Hormone receptor positive defined as ER and/or
    PgR equal or higher 10 fmol/mg cytosol protein; or equal or higher 10% of
    the tumor cells positive by immunohistochemical evaluation)
    · Patients with a baseline lumbar spine BMD T-score at or above - 2.0 SD.
    · No evidence of relapse at the time of randomization
    · Adequate marrow function (WBC > 3.0 x 10e9/L, platelets > 100.0 x
    10e9/L, and hemoglobin > 10 g/dL)
    · Adequate hepatic function (bilirubin < 30 µmol/L, ALT (SGPT) or AST (SGOT)
    < 1.5 x UNL of the institution).
    E.4Principal exclusion criteria
    To be eligible for the study a patient must not fulfill any of the following criteria:
    · ER and PgR negative or unknown
    · End of adjuvant Tamoxifen therapy more that 6 months before study
    beginning
    · Chemotherapy within the last 12 months before randomization
    · Inflammatory breast cancer
    · Abnormal renal function as evidenced by a calculated creatinine clearance
    < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the
    Cockcroft-Gault formula: CrCl= [140-age (years)] x weight (kg) / [72 x
    serum creatinine (mg/dL)] x {0.85 for female patients}
    · Current active dental problems including infection of the teeth or jawbone
    (maxilla or mandibular); dental or fixture trauma, or a current or prior
    diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the
    mouth, or of slow healing after dental procedures.
    · Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction,
    implants)
    · History of diseases with influence on bone metabolism such as Paget’s
    disease and primary hyperparathyroidism
    · Known hypersensitivity to Zometa® (Zoledronic acid) or other
    bisphosphonates
    · Patients with any clinical or radiological evidence of distant spread of their
    disease at any point before randomization.
    · Patients with any clinical or radiological evidence of existing fracture in the
    lumbar spine.
    · Patients with a history of fracture with low-density or no associated
    trauma.
    · Patients who have received prior treatment with intravenous
    bisphosphonates within the past 12 months.
    · Patients currently receiving oral bisphosphonates. Oral bisphosphonates
    must be discontinued within 3 weeks of baseline evaluations.
    · Patients who have received prior treatment with systemic corticosteroids
    within the past 12 months (short term corticosteroid therapy is allowed).
    · Patients with prior exposure to anabolic steroids or growth hormone or
    Tibolone within the past 6 months.
    · Any prior use of parathyroid hormone (PTH) for more than 1 week.
    · Prior use of systemic sodium fluoride for > 3 months during the past 2
    years.
    · Patients currently treated with any drugs known to affect the skeleton
    (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to
    randomization.
    · Patients with previous or concomitant malignancy (not breast cancer)
    within the past 5 years EXCEPT adequately treated basal or squamous cell
    carcinoma of the skin or in situ carcinoma of the cervix. Patients who have
    had a previous other malignancy must have been disease-free for five
    years.
    · Patients with other non-malignant systemic diseases including
    uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled
    thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases
    which would prevent prolonged follow-up. Patients with previous history
    of thrombosis or thromboembolism can be included only if medically
    suitable. Patients with a known history of HIV are excluded.
    · Severe physical or psychological concomitant diseases that might impair
    compliance with the provisions of the study protocol or that might impair
    the assessment of drug or patient safety, e.g. clinically significant ascites,
    cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG
    · Uncontrolled seizure disorders associated with falls.
    · History of diseases with influence on bone metabolism, such as Paget’s
    disease, Osteo-genesis Imperfecta, and primary or secondary
    hyperthyroidism within the 12 months prior to study entry.
    · Patients with baseline lumbar spine BMD T-score below –2.0 SD.
    · Patients treated with systemic investigational drug(s) and/or device(s)
    within the past 30 days or topical investigational drugs within the past 7
    days.
    · History of non-compliance to medical regimens and patients who are
    considered potentially unreliable.
    · Mental illness that precludes the patient from giving informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment difference in change in BMD measured by DXA in lumbar spine (L1-L4) at 36 months as compared to baseline.
    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 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) 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 No
    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 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
    The end of trial is defined as 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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state460
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 460
    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 Decision2005-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-19
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