Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
- Registration Number
- NCT00329940
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 treatment due to musculoskeletal disorders.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Letrozole Letrozole to evaluate the rheumatological tolerability of Femara
- Primary Outcome Measures
Name Time Method To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day at 1, 3 and 6 months of letrozole treatment
- Secondary Outcome Measures
Name Time Method To determine how long letrozole treatment is maintained at 1, 3 and 6 months of letrozole treatment To determine the causes of discontinuation at 1, 3 and 6 months of letrozole treatment
Trial Locations
- Locations (1)
Novartis Investigative Site
🇫🇷Saint Cloud, France