A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab
 (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line
 treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2)
 overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to
 receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading
 dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg
 iv. The anticipated time on study treatment was until disease progression, and the target
 sample size was 100-500 individuals.
Inclusion Criteria:

 -  postmenopausal women;

 -  metastatic breast cancer suitable for endocrine therapy;

 -  positive hormone receptor status;

 -  Human epidermal growth factor receptor 2 (HER2) overexpression.

 Exclusion Criteria:

 -  patients on hormone replacement therapy;

 -  previous chemotherapy for metastatic disease;

 -  uncontrolled cardiac disease and history of cardiac failure.