6/27/23, 11:46 PM ACOSOG Z0011 (5-year survival) Pathway Feedback Search Clinical Topics Home Studies ACOSOG Z0011 5-year survival) ACOSOG Z0011 5-year survival) Trial question Is sentinel lymph node dissection noninferior to axillary lymph node dissection in female patients with clinical T1-T2 invasive breast cancer? Study design Multi-center Open label RCT Population 891 female patients Inclusion criteria: female patients with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 sentinel lymph nodes containing metastases Key exclusion criteria: metastases identified initially or solely with immunohistochemical staining, 3 positive SLNs, matted nodes, gross extranodal disease, or receipt of neoadjuvant hormonal or chemotherapy Interventions N=446 sentinel lymph node dissection (no further axillary-specific intervention) N=445 complete axillary lymph node dissection (dissection of 10 nodes) Primary outcome Overall survival at 5 years 92.5 % 92.5 91.8 69.4 % 46.3 % Difference not exceeding nonferiority margin 23.1 % 0.0 % Sentinel lymph node dissection Complete axillary lymph node dissection Difference not exceeding nonferiority margin in overall survival at 5 years (92.5% vs. 91.8%; HR 0.79, 90% CI 0.56 to 1.1) Secondary outcomes https://web.pathway.md/studies/recc2JY2k1ydH61hi 1/2 6/27/23, 11:46 PM ACOSOG Z0011 (5-year survival) Pathway No significant difference in disease-free survival at 5 years (83.9% vs. 82.2%; HR 0.82, 95% CI 0.58 to 1.17) No significant difference in local recurrence at 5 years (1.6% vs. 3.1%; RR 0.51, 95% CI -0.12 to 1.14) No significant difference in locoregional recurrence-free survival at 5 years (96.7% vs. 95.7%; RR 1.01, 95% CI -0.81 to 2.83) Conclusion In female patients with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 sentinel lymph nodes containing metastases, sentinel lymph node dissection was noninferior to complete axillary lymph node dissection with respect to overall survival at 5 years. Reference Giuliano AE, Hunt KK, Ballman KV et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. Open reference URL https://web.pathway.md/studies/recc2JY2k1ydH61hi 2/2