Sentinel lymph node biopsy (SLNB) has been recommended as the standard performance for negative sentinel lymph node (SLN) patients without axillary lymph node dissection (ALND) in the surgical management of early breast cancer; however, the efficiency of SLNB for patients with positive SLNs is still unclear. We performed this meta-analysis to compare the effectiveness and safety of SLNB with ALND. Randomized controlled trials (RCTs) comparing SLNB with ALND in early breast cancer were identified in Pubmed, Embase, and The Cochrane Library. Overall survival (OS), disease-free survival (DFS), regional lymph node recurrence, postoperative morbidity, and quality of life (QOL) between the two groups were assessed by using the methods provided by the Cochrane Handbook for Systematic Reviews of Interventions. Eight well-designed RCTs (total 8,560 patients; 4,301 for SLNB and 4,259 for ALND) were included. Meta-analysis showed that there was no statistical difference in OS (HR = 1.07, 95% CI: 0.90-1.27), DFS (HR = 1.00, 95% CI: 0.88-1.14), and regional lymph node recurrence (OR = 1.65, 95% CI: 0.77-3.56) between SLNB and ALND group, whether for SLN (+) subgroup or for SLN (-) subgroup. However, SLNB results in a significant reduction of postoperative morbidity and improved QOL. In conclusion, SLNB can be recommended as preferred care for SLN-negative patients and selected patients with SLN-micrometastasis. Despite this, ALND remains the standard management in breast cancer patients with SLN-macrometastasis.