Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study

Study Overview
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Brief Summary
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The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.

Detailed Description
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AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela. Arm1： Participants received preoperative computed tomographic lymphography Participants received sentinel lymph node biopsy（SLNB） Participants received stained non-sentinel lymph node resection during SLNB Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy

Official Title
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Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Participants receive SLNB as well as non SLNs resection


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) participants planed to perform SLNB Exclusion Criteria: pathological diagnosed ductal carcinoma in situ by excisional biopsy the result of fine needle aspiration cytology was positive participants 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 and non-slns resection<br>Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection | Procedure: Participants receive SLNB as well as non SLNs resection<br>* Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection<br>|
| Experimental: SLNB group<br>Participants only receive SLNB | Procedure: Participants receive SLNB as well as non SLNs resection<br>* Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection<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 |