Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Hormones; Letrozole

Criteria

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.