A Prospective Randomized Multicenter Phase III Study of Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node--the Validation of Z0011 in China
To determine the effects of complete axillary lymph node dissection (ALND) on survival of
patients with sentinel lymph node (SLN) metastasis of breast cancer.
OUTLINE: This is a randomized multicenter study. Before randomization, all women were
stratified according to age (≤50 years, >50 years), tumor size(≤2cm, >2cm) and research
center. All the patients underwent lumpectomy and sentinel lymph node biopsy (SLNB).
Eligible women were randomly assigned to ALND or no ALND Active Comparator: Patients undergo
axillary lymph node dissection involving removal of at least level I and II nodes.
Experimental: No surgery of axillary lymph node in this arm. All the patients were to
receive whole-breast opposing tangential-field radiation therapy. The use of adjuvant
systemic therapy was determined by the treating physician according to the recently NCCN.
Patients are followed up every 4 months for the first 2 years, every 6 months from the third
year to the fifth year, and then annually for a total of 10 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Free Survival
Time from randomization to relapse or death.
Time to relapse or progression up to 10 years
Yong-sheng Wang, MD
Shandong Cancer Hospital and Institute
China: Ministry of Health