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
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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
Sites / Locations
- Qifeng YangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
qifengy_sdu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Li
Phone
+8618560080551
Email
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
Email
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
We'll reach out to this number within 24 hrs