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

• Conditions: Sentinel Lymph Node; Breast Cancer
• Interventions: Diagnostic Test: mapping agent; Procedure: neoadjuvant chemotherapy

• Registration Number: NCT04156841
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
performed SLNB by combination of blue dye and radiotracer	mapping agent	-
underwent SLN surgery receiving neoadjuvant chemotherapy	neoadjuvant chemotherapy	-
performed SLNB using a single mapping agent	mapping agent	-
underwent SLN surgery not receiving neoadjuvant chemotherapy	neoadjuvant chemotherapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
incidence of infection events after SLNB in patients with early stage breast cancer in China	2021-12-31	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.

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China