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

Novartis

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329940

CFEM345DFR04

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Letrozole

Experimental group

Description:

to evaluate the rheumatological tolerability of Femara

Treatment:

Drug: Letrozole