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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Participants receive SLNB as well as non SLNs resection

• Registration Number: NCT03857932
• Lead Sponsor: Shandong University

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：

1. Participants received preoperative computed tomographic lymphography

2. Participants received sentinel lymph node biopsy（SLNB）

3. Participants received stained non-sentinel lymph node resection during SLNB

4. Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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. participants 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. participants has received neo-adjuvant system therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLNB group	Participants receive SLNB as well as non SLNs resection	Participants only receive SLNB
SLNB and non-slns resection	Participants receive SLNB as well as non SLNs resection	1. Participants only receive SLNB 2. preoperative CT lymphography 3. SLNB with stained non-SLN resection 4. SLNB with ARM dissection

Primary Outcome Measures

Name	Time	Method
Disease free survival	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

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

Trial Locations

Locations (1)

Qifeng Yang; 🇨🇳 Jinan, Shandong, China