Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
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.
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.
Inclusion Criteria:

 -  Female;

 -  Patient aged 18 years and above;

 -  Patient with histological proven invasive breast cancer;

 -  Clinical T1-T2 disease with no distant metastasis;

 -  Patient with clinical N0 status;

 -  Patient for whom conservative surgery with sentinel lymph node (SLN) technique is
 feasible from the start in terms of carcinologic;

 -  Patient with positive SLNs 1~2;

 -  Signed consent to participate.

 Exclusion Criteria:

 -  History of neoadjuvant chemotherapy or hormone therapy;

 -  History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);

 -  History of any other invasive cancer;

 -  Initial metastatic disease known;

 -  Pregnant women or lactating women;

 -  Impossibility to undergo medical examinations of the study for geographical, social or
 psychological reasons.