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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Genentech, Inc.
• Treatments: Anastrozole; Aromatase Inhibitors; Trastuzumab

Criteria

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.