Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Patients receive SLNB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy abnormal para-sentinel lymph node was found by ultrasound examination ultrasound-guided fine needle aspiration cytology of these nodes were performed the result of fine needle aspiration cytology was negative (no tumour cell was found) patient planed to perform SLNB Exclusion Criteria: pathological diagnosed ductal carcinoma in situ by excisional biopsy the result of fine needle aspiration cytology was positive patient has received neo-adjuvant system therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLNB with para-SLN dissection<br>patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection | Procedure: Patients receive SLNB<br>* Patients receive sentinel lymph node biopsy<br>|
| Experimental: SLNB without para-SLN dissection<br>patients received sentinel lymph node biopsy | Procedure: Patients receive SLNB<br>* Patients receive sentinel lymph node biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease 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. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from randomization to death from any cause, assessed up to 10 years. | Up to 10 years |