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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Patients receive SLNB

• Registration Number: NCT02651142
• Lead Sponsor: Shandong University

Brief 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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-31
• Last Update Posted: 2020-06-02
• Primary Completion: 2021-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
2. abnormal para-sentinel lymph node was found by ultrasound examination
3. ultrasound-guided fine needle aspiration cytology of these nodes were performed
4. the result of fine needle aspiration cytology was negative (no tumour cell was found)
5. patient planed to perform SLNB

Exclusion Criteria

1. pathological diagnosed ductal carcinoma in situ by excisional biopsy
2. the result of fine needle aspiration cytology was positive
3. patient has received neo-adjuvant system therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLNB without para-SLN dissection	Patients receive SLNB	patients received sentinel lymph node biopsy
SLNB with para-SLN dissection	Patients receive SLNB	patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection

Primary Outcome Measures

Name	Time	Method
Disease free survival	Up to 10 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 10 years	Time from randomization to death from any cause, assessed up to 10 years.

Trial Locations

Locations (1)

Qifeng Yang; 🇨🇳 Jinan, Shandong, China