Objective:The aim of the study is analyze the recurrence, metastasis and prognosis of early breast cancer patients and evaluate the long-term safety of tracer sentinel lymph node biopsy (SLNB) using indocyanine green (ICG) and methylene blue (MB) in early breast cancer.Methods:A total of 394 breast cancer patients were enrolled from January 1, 2014 to December 31, 2014 in Affiliated Hospital of Chengde Medical University. The baseline data and clinical characteristics of 222 patients who met the inclusion criteria were analyzed.Results:The median follow-up time of 222 patients was 57 months. The detection rate of sentinel lymph nodes (SLNs) using ICG or MB alone was 96.4% and 84.7% ( P=0.02); the number of SLNs detected was 740 and 604 ( P<0.001); the positive SLN detection rates were 100% and 91% ( P=0.014), and the positive SLNs were 221 and 195 ( P<0.001). The local recurrence rates were 0.7% in patients without axillary lymph node dissection (ALND) and 1.4% ( P=0.57) in patients with ALND, and the distant metastasis rates were 5.3% and 15.7% ( P=0.01), respectively. The 5-year overall survival (OS) was 4.7% and 91.7% ( P=0.421), and the disease-free survival (DFS) was 90.5% and 85.9% ( P=0.285). The OS and DFS of the 222 patients were 100%, 96.8%, 94.1% and 100%, 96.4% and 89.2% respectively at 1, 3 and 5 years after operation. Multivariate COX regression model showed that age ≤50 years old, triple negative molecular classification and primary tumor >2 cm were independent risk factors for prognosis, and HR were 3.254, 7.321 and 3.507, respectively (all P<0.05). Conclusions:Sentinel lymph node biopsy with indocyanine green combined with methylene blue is a safe and reliable method for axillary staging of breast cancer. The COX regression models showed that patients with younger age, three-negative molecular type and larger primary tumor were more likely to have adverse events.