A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer

This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.

Inclusion Criteria:

• Female patients > or = 18 years of age
• Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
• Previously treated with adjuvant antracycline containing chemotherapy
• Left Ventricular Ejection Fraction (LVEF) > 50%
• Eastern Cooperative Oncology Group (ECOG) score < or = 2
• Life expectancy > or = 12 weeks

Exclusion Criteria:

• Left Ventricular Ejection Fraction (LVEF) < 50%
• Advanced pulmonary disease
• Severe dyspnea
• Abnormal laboratory results within 14 days prior to registration
• Peripheral neuropathy
• Presence of Central Nervous System (CNS) metastasis