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Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Participants receive SLNB as well as non SLNs resection

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:

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)
participants planed to perform SLNB

Exclusion Criteria:

pathological diagnosed ductal carcinoma in situ by excisional biopsy
the result of fine needle aspiration cytology was positive
participants has received neo-adjuvant system therapy

Sites / Locations

Qifeng YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SLNB and non-slns resection

SLNB group

Arm Description

Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection

Participants only receive SLNB

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

NCT ID

NCT03857932

First Posted

February 26, 2019

Last Updated

August 25, 2021

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT03857932

Brief Title

Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study

Official Title

Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.

Detailed Description

AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela. Arm1： Participants received preoperative computed tomographic lymphography Participants received sentinel lymph node biopsy（SLNB） Participants received stained non-sentinel lymph node resection during SLNB Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy

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

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SLNB and non-slns resection

Arm Type

Experimental

Arm Description

Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection

Arm Title

SLNB group

Arm Type

Experimental

Arm Description

Participants only receive SLNB

Intervention Type

Procedure

Intervention Name(s)

Participants receive SLNB as well as non SLNs resection

Intervention Description

Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection

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

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) participants planed to perform SLNB Exclusion Criteria: pathological diagnosed ductal carcinoma in situ by excisional biopsy the result of fine needle aspiration cytology was positive participants has received neo-adjuvant system therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qifeng Yang

Phone

+8618560085168

qifengy_sdu@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoyan Li

Phone

+8618560080551

wdjlc108822@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qifeng Yang

Organizational Affiliation

Qilu Hospital, Shandong University

Official's Role

Principal Investigator

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

wdjlc108822@163.com

12. IPD Sharing Statement

Learn more about this trial

Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study

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