Using FCM (flow cytometry), we analyzed the ErbB-2 (c-erbB-2 protein) status of 61 breast cancer tissue samples obtained by FNAB (fine-needle aspiration biopsy). The number of cancer cells collected by FNAB from fresh samples was 1.7+/-0.7 x10&sup5;, 2.5 +/-0.6 x10&sup5;, and 4.0+/- 0.8x10 &sup5;, by single, double and triple aspirations, respectively. A mean of 3.0+/-0.6 x10&sup5;cells was collected on three aspirations from frozen samples. The number of cells collected on three aspirations was sufficient for the measurement of ErbB-2. Cells with higher ErbB-2 levels than those of normal human lymphocytes were designated ErbB-2 positive cells. The mean overall for ErbB-2 positive cell rates was 20.5 +/- 27.9 % (mean+/-SD). The rates were 27.9 +/- 31.6 % in patients with recurrence and 15.9 +/- 24.4% in patients without recurrence. When the cut-off value was set at 20% of the positive cell rate (P =0.008, generalized Wilcoxon test), patients with ErbB-2 negative tumors showed highly significantly longer survival without recurrence (P=0.008, generalized Wilcoxontest) and better overall survival rates (P=0.013) than patients with ErbB-2 positive tumors. Among 61 specimens, 16 (26.2%) scored positive for ErbB-2 by FCM. These finding indicated that the analysis of ErbB-2 status using FCM of samples obtained by FNAB should be useful for preoperatively evaluating the prognosis of patients with breast cancer.