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

Novartis Pharmaceuticals200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Breast Cancer

Interventions

LetrozoleDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Saint-Cloud, France

Outcomes

Primary Outcomes

To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day

Time frame: at 1, 3 and 6 months of letrozole treatment

Secondary Outcomes

To determine the causes of discontinuation

Time frame: at 1, 3 and 6 months of letrozole treatment

To determine how long letrozole treatment is maintained

Time frame: at 1, 3 and 6 months of letrozole treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.