Sentinel lymph node biopsy(SLNB) is an established way of predicting axillary nodal metastasis in early breast cancer. We aim to determinethe,in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.
Aim: Compare the disease-free survival (DFS) and overall survival (OS) of breast cancer patients who are randomized to receive sentinel lymph node biopsy with para-sentinel lymph node dissection group vs. those receive only sentinel lymph node biopsy without para-sentinel lymph node dissection Outline: Patients are randomized assigned to the following one of two groups and are followed annually. Arm I: Patients receive sentinel lymph node biopsy with para-sentinel lymph node dissection Arm II: Patients receive only sentinel lymph node biopsy without para-sentinel lymph node dissection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Patients receive sentinel lymph node biopsy
Qifeng Yang
Jinan, Shandong, China
RECRUITINGDisease free survival
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
Time frame: Up to 10 years
Overall survival
Time from randomization to death from any cause, assessed up to 10 years.
Time frame: Up to 10 years
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