Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

Study Overview
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Brief Summary
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Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.

Official Title
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Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

Conditions
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Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Diagnostic Test: mapping agent
* Procedure: neoadjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast cancer confirmed by fine needle aspiration or biopsy SLNB with or without axillary lymph node dissection receiving conventional systematic treatment or regional treatment complete medical record. Exclusion Criteria: IV stage breast cancer combined with secondary invasive malignant tumor diagnosed with other serious disease, including congestive heart failure (NYHA cardiac function grade II, III, IV) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months difficulty breathing at rest or need oxygen therapy severe infection uncontrolled diabetes serious psychological or mental disorders poor compliance.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| performed SLNB using a single mapping agent<br> | Diagnostic Test: mapping agent<br>* according to different tracer methods, patients are divided into the implementation of a single mapping agent and implementation of combination of blue dye and radiotracer agent.<br>|
| performed SLNB by combination of blue dye and radiotracer<br> | Diagnostic Test: mapping agent<br>* according to different tracer methods, patients are divided into the implementation of a single mapping agent and implementation of combination of blue dye and radiotracer agent.<br>|
| underwent SLN surgery receiving neoadjuvant chemotherapy<br> | Procedure: neoadjuvant chemotherapy<br>* Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.<br>|
| underwent SLN surgery not receiving neoadjuvant chemotherapy<br> | Procedure: neoadjuvant chemotherapy<br>* Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China | the performance rate of SLNB refers to the number of patients implementing SLNB divided by the total number of breast cancer patients | 2020-12-31 | 
| the positive rate of SLNs in patients with early stage breast cancer in China | SLNs positive rate is the number of positive SLN patients divided by the number of patients implementing SLNB | 2020-12-31 | 
| the number of resected SLNs in patients with early stage breast cancer in China | the average number of resected SLNB will be calculated | 2020-12-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of infection events after SLNB in patients with early stage breast cancer in China | incidence of infection events is the number of patients who have an infection event after SLNB divided by the total number of patients implementing SLNB. The infection events include incision infection, local skin infection and injured vascular infection. | 2021-12-31 |