Status:
COMPLETED
Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00329940
Start Date
November 1 2005
Last Update
February 24 2017
Active Locations (1)
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1
Novartis Investigative Site
Saint-Cloud, France