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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857932
• Other study ID #: HECT004
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2021
• Source: Shandong University
• Contact: Qifeng Yang
• Phone: +8618560085168
• Email: qifengy_sdu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Participants receive SLNB as well as non SLNs resection
Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection

Locations

Country	Name	City	State
China	Qifeng Yang	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Time from randomization to death from any cause, assessed up to 10 years.	Up to 10 years