Abstract. Background: Serum HER2 testing allows the determination of real-time HER2 status during clinical course. The aim of this investigation was: (1) to study the prognostic significance of serum HER2 at the time of first diagnosis of metastatic breast cancer and (2) to evaluate its relationship to CA15-3 which is a surrogate marker for tumor load. Materials and Methods: Serum samples of 120 breast cancer patients were assayed for HER2 and CA15-3 at the onset of metastatic disease. Results: Forty-seven out of 120 (39%) metastatic breast cancer patients had elevated serum HER2 levels. The positvity rate of CA 15-3 was 51%. The median survival after relapse (SAR) for HER2-positive patients was shorter (10 months, 95%-CI: 6-14 months) compared to the SAR of HER2-negative patients (19 months, 95%-CI:15-23 months) (p<0.01). The median survival of patients with increased CA 15-3 was 13 months (95%-CI: 9-1

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