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

NCT ID: NCT02651142

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2025-01-31

Brief Summary

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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

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SLNB with para-SLN dissection

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

Group Type EXPERIMENTAL

Patients receive SLNB

Intervention Type PROCEDURE

Patients receive sentinel lymph node biopsy

SLNB without para-SLN dissection

patients received sentinel lymph node biopsy

Group Type EXPERIMENTAL

Patients receive SLNB

Intervention Type PROCEDURE

Patients receive sentinel lymph node biopsy

Interventions

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Patients receive SLNB

Patients receive sentinel lymph node biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Qifeng Yang

Chairman of Department of Breast Surgery, Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qifeng Yang

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qifeng Yang, Professor

Role: CONTACT

+8618560085168

Xiaoyan Li, Resident

Role: CONTACT

+8618560080551

Facility Contacts

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Qifeng Yang

Role: primary

+8618560085168

Xiaoyan Li

Role: backup

+8618560080551

References

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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.

Reference Type DERIVED
PMID: 31057616 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28968971 (View on PubMed)

Other Identifiers

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HECT003

Identifier Type: -

Identifier Source: org_study_id

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