Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Letrozole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
Official title: Assessment of Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer Having Discontinued Anastrozole Adjuvant Treatment Due to Musculoskeletal Disorders
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day
Secondary outcome: To determine the causes of discontinuationTo determine how long letrozole treatment is maintained
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Novartis Investigative Site, Saint Cloud, France
Additional Information
Starting date: November 2005
Last updated: August 6, 2012
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