NCT02651142

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Patients receive SLNB	Patients receive sentinel lymph node biopsy

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-01-01
• Completion: 2025-01-01
• First posted: 2016-01-08
• Last updated: 2020-06-02

Locations

1 site across 1 country: China