Klin Onkol 2009; 22(1): 3-10.

Summary
Breast cancer is the second most common type of cancer in women after skin cancer. Between 15 to 25% of breast cancers are characterized by overexpression of human epidermal growth factor receptor 2 (HER-2). HER-2 overexpression has been associated with more aggressive tumor phenotype, poor prognosis and shortened survival. Humanized monoclonal antibody trastuzumab was the fi rst targeted therapy against HER-2 used in clinical practice. Trastuzumab has signifi cantly improved the prognosis of HER-2 overexpressing breast cancer, is effective as a single agent or in combination with chemotherapy, has proven effi cacy in the treatment of metastatic breast cancer and also in adjuvant and neoadjuvant setting. Despite trastuzumab success in treatment, several important questions are still not clearly answered. The most discussed issues are the optimal selection of patients with regard to HER-2 testing, combination of trastuzumab with anthracyclines, comparison of the effi cacy of trastuzumab in combination with different chemotherapy regimens, the ideal scheduling of trastuzumab administration, the duration of treatment, especially in adjuvant therapy, continuation of trastuzumab treatment beyond disease progression and after development of brain metastasis. Trastuzumab is generally well tolerated and the clinically most important adverse effect is potential for congestive heart failure, therefore careful cardiac monitoring is required for all patients receiving this therapy. Aim of this article is to summarize the results of clinical trials with trastuzumab and refer to some issues concerning trastuzumab administration and toxicity.