Abstract
It has been more than 10 years since the initial report of an association between amplification of erbB-2 (also known as HER-2/neu and ERBB2) and poor clinical outcome of patients with primary breast cancer (1). Dozens of papers involving thousands of patients have now been published on this topic, and the general conclusion is that erbB-2 abnormalities, either gene amplification or protein overexpression, are associated with worse prognosis of patients with lymph node-positive breast cancer, but the relationship for patients with lymph node-negative disease is weak, at best. Since most of these correlative studies were retrospective and many of the patients were treated before adjuvant therapy was widely administered to patients with lymph node-negative disease, several clinical researchers speculated that these associations were due, in part, to specific adjuvant therapies received by lymph node-positive patients.