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    Summary
    EudraCT Number:2005-004263-35
    Sponsor's Protocol Code Number:CFEM345D2411
    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: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 ConcernedAustria - BASG
    A.2EudraCT number2005-004263-35
    A.3Full title of the trial
    A randomised multi-center Phase IIIb, open label, study of letrozole vs anastrazole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberCFEM345D2411
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressStella-Klein-Löw-Weg 17
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1020
    B.5.3.4CountryAustria
    B.5.4Telephone number+431866576452
    B.5.5Fax number+43186657 16452
    B.5.6E-mailbarbara.aschauer@novartis.com
    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 Femara
    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 nameFemara
    D.3.2Product code FEM345
    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 INNletrozole
    D.3.9.1CAS number 112809-51-5
    D.3.9.2Current sponsor codeFEM345
    D.3.9.3Other descriptive nameletrozole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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 Arimidex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.4Pharmaceutical 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.3.9.1CAS number 120511-73-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    This study will be a head to head comparison of letrozole versus anastrozole in the adjuvant treatment of high risk patients. Post-menopausal patients who recently have undergone their primary surgery for their breast cancer are targeted patient population. They must also have hormone positive disease and have lymph node positive disease. The primary surgery could have been a total mastectomy, lumpectomy or quadrantectomy for primary 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
    To compare the rate of disease free survival (DFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between letrozole and anastrozole.
    E.2.2Secondary objectives of the trial
    • To compare the general safety between the two treatment arms.
    • To compare the two treatment groups in a descriptive manner with the other indicators of efficacy including overall survival, time to development of distant metastases, time to development of contra lateral breast cancer and distant disease- free survival.
    • Compare the effect of treatment on serum lipid profiles between treatment arms, and describe the incidence of cardiovascular events in each treatment arm
    • Describe the incidence of bone fractures in each treatment arm

    REFER TO PROTOCOL AMENDMENT#3 FOR NEW ADDED SECONDARY OBJECTIVES
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Correlative science studies, including immunohistochemical analyses, tumor RNA profiling, tissue microarray analysis, estradiol, estrone and estrone sulphate levels, pharmacogenetics and proteomics, will be conducted in a subset of patients to better understand which predictors define the course of each breast cancer patient's disease.
    E.3Principal inclusion criteria
    1. Provision of written informed consent.
    2. Patient must be female.
    3. Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following:
    • A total mastectomy with institutional standard axillary nodal dissection.
    • A lumpectomy or a quadrantectomy with institutional standard axillary dissection with breast radiotherapy (may be deferred until chemotherapy is completed) in accordance with breast preservation.
    • Treatment of the breast cancer following diagnosis may have included any of the following: post-lumpectomy/quadrantectomy regional radiotherapy, post-mastectomy locoregional radiotherapy, postoperative chemotherapy, and trastuzumab.
    4. The tumor must have been pathologic or clinical stage IIA to IIIC invasive carcinoma of the breast documented by core needle or open biopsy. Patients with Paget’s disease of the nipple are eligible.
    5. The date of randomization must be no more than:
    • 12 weeks from completion of surgery or adjuvant chemotherapy
    • Investigators are encouraged to enroll patients as soon as possible after the completion of adjuvant chemotherapy.
    Note adjuvant radiation and endocrine therapy e.g. letrozole and anastrozole can be given at the same time as radiotherapy due to non-overlapping toxicity profile.
    6. Presence of node positive disease.
    Positive node is defined as the presence of at least micro metastasis greater than 0.2 mm according to the AJCC Breast Staging Criteria Edition 6.
    7. Patients who have had neoadjuvant chemotherapy are eligible. Positive lymph node involvement can be defined either prior to neoadjuvant chemotherapy or at the time of surgery following their neoadjuvant therapy. Lymph node positivity would bedefined as the following: REFER TO CURRENT PROTOCOL FOR DETAILS
    8. Presence of occult axillary lymph node (pN1-pN3b) with no evidence of primary breast tumor (T0) or only DCIS identified and whose metastases are isolated to axillary lymph nodes associated with the following:
    • Lymph node reflects invasive adenocarcinoma histology
    • Measurement of ER, PR, and HER2 must be performed on initial lymph nodes that were biopsied.
    • Complete staging evaluation required as per standard institutional practices to exclude any other primary sites of disease, including metastatic disease.
    9. Bilateral, synchronous breast cancer is allowed provided at least one of the primary tumors meets the eligibility criteria.
    10. Hormone receptor-positive tumors, defined as any detectable estrogen or progesterone receptor expression by institutional standards. Patients who are PR positive and ER negative are eligible for the trial. Tumor slides should be submitted for central evaluation of hormone receptor status as per Section 3.5.3.3.7 and Post-text Supplement 2.
    11. HER2 status must be known.
    Note if possible tumor slides should be submitted for central confirmation of hormone and HER2 receptor status as per Section 3.5.3.37 and Post-test Supplement 2.
    12. Physical and laboratory examinations, as per standard institutional practice, should be obtained at the time of definitive surgery to demonstrate there is no evidence of metastatic or recurrent disease.
    13. Patients must have an WHO performance status of 0 or 1(0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory)
    14. Patients must be postmenopausal at the time of initial diagnosis. For study purposes, postmenopausal is defined as: REFER TO CURRENT PROTOCOL FOR DETAILS
    15. WBC ≥ 3.0 x 109/L and platelets ≥ 100 x 109/L.
    16. AST/SGOT or ALT/SGPT ≤ 3 times ULN.
    17. Serum creatinine ≤ 2 times ULN.
    18. Ability to swallow whole tablets.
    E.4Principal exclusion criteria
    1. Presence of metastatic disease or inflammatory breast cancer as documented by dermal lymphatic invasion.
    2. Presence of metachronous bilateral breast cancer.
    3. Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell carcinoma of the skin.
    4. Presence of other non-malignant systemic diseases which may prevent prolonged follow-up.
    5. Received neoadjuvant endocrine therapy
    6. Hormone replacement therapy (HRT) other than Estring®, Vagifem® or low dose estrogen vaginal cream, not stopped at least 4 weeks before randomization. Thyroid replacement, insulin or other anti-diabetic medication are permitted to be continued.
    7. Adjuvant anti-estrogen therapy for more than 1 month immediately following surgery, radiotherapy and/or chemotherapy.
    8. Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer.
    9. Severe hepatic dysfunction defined as Child-Pugh grade C. REFER TO TABLE 3-2 IN THE CURRENT PROTOCOL
    10. Therapy with any hormonal agent such as raloxifene for management of osteoporosis. (Patients are eligible only if these medications are discontinued 4 weeks prior to randomization.)
    E.5 End points
    E.5.1Primary end point(s)
    Disease Free Survival
    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 Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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
    N/A
    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 years7
    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 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 state195
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2162
    F.4.2.2In the whole clinical trial 4032
    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)
    N/A
    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 Decision2006-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-08
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