At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Sentinel Lymph Node Biopsy, Intraoperative Pathological Examination, and 4 other interventions for Breast Cancer. Withdrawn before enrollment, across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
touch imprint cytology and/or frozen section and/or OSNA
Axillary lymph node dissection involving removal of at least level I and II nodes.
H\&E and IHC
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Whole-breast opposing tangential-field radiation therapy.