Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
NCT ID: NCT00329940
Last Updated: 2017-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Letrozole
to evaluate the rheumatological tolerability of Femara
Letrozole
Interventions
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Letrozole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Saint-Cloud, , France
Countries
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Other Identifiers
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CFEM345DFR04
Identifier Type: -
Identifier Source: org_study_id
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