In spite of the heterogeneity of breast cancer at the molecular level, circulating tumor cells (CTCs) may provide a novel prognostic marker. Approximately 20-40% of early breast cancer patients have detectable CTCs using reverse transcription PCR for CK19. The detection of CTCs before adjuvant chemotherapy or during tamoxifen administration has been demonstrated to be an independent adverse prognostic factor in women with early-stage breast cancer. The prognostic value of CTC detection is of great significance in subgroups of patients with estrogen receptor-negative and human EGF receptor 2-positive tumors. Prospective clinical trials are warranted in order to validate the use of CTCs as predictive and/or prognostic markers and assess their utility in individualizing therapy of patients with early breast cancer.