Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer
May 31, 2020 updated by: Qifeng Yang, Shandong University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qifeng Yang, Professor
- Phone Number: +8618560085168
- Email: qifengy_sdu@163.com
Study Contact Backup
- Name: Xiaoyan Li, Resident
- Phone Number: +8618560080551
- Email: wdjlc108822@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qifeng Yang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
- abnormal para-sentinel lymph node was found by ultrasound examination
- ultrasound-guided fine needle aspiration cytology of these nodes were performed
- the result of fine needle aspiration cytology was negative (no tumour cell was found)
- patient planed to perform SLNB
Exclusion Criteria:
- pathological diagnosed ductal carcinoma in situ by excisional biopsy
- the result of fine needle aspiration cytology was positive
- patient has received neo-adjuvant system therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SLNB with para-SLN dissection
patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection
|
Patients receive sentinel lymph node biopsy
|
|
Experimental: SLNB without para-SLN dissection
patients received sentinel lymph node biopsy
|
Patients receive sentinel lymph node biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease free survival
Time Frame: 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.
|
Up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: Up to 10 years
|
Time from randomization to death from any cause, assessed up to 10 years.
|
Up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ma X, Wen S, Liu B, Li D, Wang X, Kong X, Ma T, Jiang L, Yang Q. Relationship between Upper Extremity Lymphatic Drainage and Sentinel Lymph Nodes in Patients with Breast Cancer. J Oncol. 2019 Apr 1;2019:8637895. doi: 10.1155/2019/8637895. eCollection 2019.
- Li X, Chen S, Jiang L, Kong X, Ma T, Xu H, Yang Q. Precise intraoperative sentinel lymph node biopsies guided by lymphatic drainage in breast cancer. Oncotarget. 2017 Jun 27;8(38):63064-63072. doi: 10.18632/oncotarget.18624. eCollection 2017 Sep 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
January 7, 2016
First Submitted That Met QC Criteria
January 7, 2016
First Posted (Estimate)
January 8, 2016
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
May 31, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HECT003
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