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Brief Title: Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Official Title: 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
Study ID: NCT01796444
Brief Summary: The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node dissection (ALND) did not result in inferior survival. These patients, therefore, are unlikely to benefit from further surgery that results in a longer period of hospitalization, higher costs and higher postoperative morbidity. This result has been written in the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines. However, Limitations of Z0011, such as failure to achieve target accrual and possible randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand, further testing in different country are needed. The investigators design and begin a prospective randomized multicenter phase III study of ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.
Detailed Description: OBJECTIVES: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Shandong Cancer Hospital and Institute, Jinan, Shandong, China
Name: Yong-sheng Wang, MD
Affiliation: Shandong Cancer Hospital and Institute
Role: STUDY_CHAIR
Name: Tao Ouyang, MD
Affiliation: Beijing Cancer Hospital and Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Jiong Wu, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Feng-xi Su, MD
Affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Hong-yuan Li, MD
Affiliation: First Affiliated Hospital of Chongqing Medical University
Role: PRINCIPAL_INVESTIGATOR