Official Title: “Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer”

Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Letrozole, anastrozole

Primary Measures

• Compare rate of disease free survival at 5 years between letrozole and anastrozole

Secondary Measures

• Safety
• Efficacy
• Overall survival
• Breast cancer specific survival
• Time to development of distant metastases

Inclusion Criteria

• Recent primary surgery for breast cancer
• Early stage breast cancer
• Postmenopausal
• Hormone receptor positive
• Positive lymph node involvement

Exclusion Criteria

• Metastatic disease
• Presence of contralateral breast cancer including DCIS
• Progression
• Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00248170

Study ID Number: CFEM345D2411

ClinicalTrials.gov Identifier: NCT00248170

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration