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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651142
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Qifeng Yang, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Patients receive SLNB Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SLNB with para-SLN dissection
patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection
Procedure: Patients receive SLNB
Patients receive sentinel lymph node biopsy

Experimental: SLNB without para-SLN dissection
patients received sentinel lymph node biopsy
Procedure: Patients receive SLNB
Patients receive sentinel lymph node biopsy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 10 years ]
    Time from randomization to death from any cause, assessed up to 10 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651142


Contacts
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Contact: Qifeng Yang, Professor +8618560085168 qifengy_sdu@163.com
Contact: Xiaoyan Li, Resident +8618560080551 wdjlc108822@163.com

Locations
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China, Shandong
Qifeng Yang Recruiting
Jinan, Shandong, China, 250012
Contact: Qifeng Yang    +8618560085168      
Contact: Xiaoyan Li    +8618560080551    wdjlc108822@163.com   
Sponsors and Collaborators
Shandong University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qifeng Yang, Chairman of Department of Breast Surgery, Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02651142    
Other Study ID Numbers: HECT003
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases