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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Patients receive SLNB
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Qifeng YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SLNB with para-SLN dissection

SLNB without para-SLN dissection

Arm Description

patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection

patients received sentinel lymph node biopsy

Outcomes

Primary Outcome Measures

Disease free survival
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

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

Full Information

First Posted
January 7, 2016
Last Updated
May 31, 2020
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02651142
Brief Title
Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SLNB with para-SLN dissection
Arm Type
Experimental
Arm Description
patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection
Arm Title
SLNB without para-SLN dissection
Arm Type
Experimental
Arm Description
patients received sentinel lymph node biopsy
Intervention Type
Procedure
Intervention Name(s)
Patients receive SLNB
Intervention Description
Patients receive sentinel lymph node biopsy
Primary Outcome Measure Information:
Title
Disease free survival
Description
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.
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from randomization to death from any cause, assessed up to 10 years.
Time Frame
Up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qifeng Yang, Professor
Phone
+8618560085168
Email
qifengy_sdu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Li, Resident
Phone
+8618560080551
Email
wdjlc108822@163.com
Facility Information:
Facility Name
Qifeng Yang
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifeng Yang
Phone
+8618560085168
First Name & Middle Initial & Last Name & Degree
Xiaoyan Li
Phone
+8618560080551
Email
wdjlc108822@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31057616
Citation
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.
Results Reference
derived
PubMed Identifier
28968971
Citation
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.
Results Reference
derived

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

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