Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Anastrozole
Hormones
Letrozole
Criteria
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.