NCT02651142

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

6 years

First QC Date

January 7, 2016

Last Update Submit

May 31, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 10 years

Secondary Outcomes (1)

  • Overall survival

    Up to 10 years

Study Arms (2)

SLNB with para-SLN dissection

EXPERIMENTAL

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

Procedure: Patients receive SLNB

SLNB without para-SLN dissection

EXPERIMENTAL

patients received sentinel lymph node biopsy

Procedure: Patients receive SLNB

Interventions

Patients receive SLNBPROCEDURE

Patients receive sentinel lymph node biopsy

SLNB with para-SLN dissectionSLNB without para-SLN dissection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qifeng Yang

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31057616DERIVED

  • 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.

    PMID: 28968971DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Qifeng Yang, Professor

CONTACT

+8618560085168qifengy_sdu@163.com

Xiaoyan Li, Resident

CONTACT

+8618560080551wdjlc108822@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Department of Breast Surgery, Qilu Hospital

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2021

Study Completion

January 1, 2025

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations

CN(1)