- Histologically confirmed breast cancer with metastases.
- Tumor that has overexpression of HER2 as documented by being either FISH-positive or
HER2/neu 3+ confirmed by immunohistochemistry.
- Patients must be candidates for single agent Herceptin treatment according to the
- Any prior therapy with anthracycline + Herceptin®.
- Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure,
myocardial infarction within the past 6 months, unstable angina; coronary angioplasty
within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or
left ventricular ejection fraction