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

• Sponsor: Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03857932
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Participants receive SLNB as well as non SLNs resection	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
• Actual Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SLNB and non-slns resection Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection	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
Experimental: SLNB group Participants only receive SLNB	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall survival [Up to 10 years]

   Time from randomization to death from any cause, assessed up to 10 years.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qifeng Yang	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Shandong University

Investigators

• Principal Investigator: Qifeng Yang, Qilu Hospital, Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qifeng Yang, Professor, Shandong University
• ClinicalTrials.gov Identifier: NCT03857932
• Other Study ID Numbers: HECT004
• First Posted: Feb 28, 2019
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Aug 31, 2021