Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.

Detailed Description
-----------------
OBJECTIVES: Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods. Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods. OUTLINE: The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.

Official Title
-----------------
Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer

Conditions
-----------------
Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
-----------------
* Behavioral: Vacuum-Assisted Biopsy
* Behavioral: Core Needle Biopsy
* Behavioral: Intraoperative Excisional Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically lymph node negative breast cancer patients T1-T3 Exclusion Criteria: history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative Vacuum-Assisted Biopsy<br>Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost. | Behavioral: Vacuum-Assisted Biopsy<br>* Vacuum-Assisted Biopsy<br>|
| Experimental: Preoperative Core Needle Biopsy<br>Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles. | Behavioral: Core Needle Biopsy<br>* Core Needle Biopsy<br>|
| Experimental: Intraoperative Excisional Biopsy<br>The tumor was excised intraoperatively. | Behavioral: Intraoperative Excisional Biopsy<br>* Intraoperative Excisional Biopsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification rates of sentinel lymph node biopsy | Identification rate of SLNB between three groups | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification numbers of sentinel lymph node biopsy | Identification numbers of SLNB between three groups | 1 year | 
| fase-negative rates of sentinel lymph node biopsy | fase-negative rates of SLNB between three groups | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sentinel Lymph Node, vacuum-assisted biopsy, Core needle biopsy, Breast Cancer