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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00329940 |
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Date of registration:
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23/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
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Scientific title:
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Assessment of Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer Having Discontinued Anastrozole Adjuvant Treatment Due to Musculoskeletal Disorders |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00329940 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor
positive breast cancer who want to interrupt the treatment because of severe
rheumatologic adverse events
- Polymorphonuclear neutrophils (PNN) = 1200/mm3, platelets = 100000/mm3, hemoglobin
(Hb) = 10 g/dL
- Bilirubin = 30 µmol, SGOT/SGPT < 3N
- Fully signed informed consent
Exclusion Criteria:
- Pain due to bone fracture
- Metastatic disease
- Hormone therapy other than anastrozole
- Incapacitating or uncontrolled concomitant disease that could hamper patient's quality
of life
- Hypersensitivity to letrozole or its components
Other protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Letrozole
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Primary Outcome(s)
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To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day
[Time Frame: at 1, 3 and 6 months of letrozole treatment]
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Secondary Outcome(s)
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To determine how long letrozole treatment is maintained
[Time Frame: at 1, 3 and 6 months of letrozole treatment]
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To determine the causes of discontinuation
[Time Frame: at 1, 3 and 6 months of letrozole treatment]
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Secondary ID(s)
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CFEM345DFR04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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