Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Primary Purpose
Breast Cancer, Surgery, Lymph Node Metastases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tissue Marker Clip
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0)
- accord with the indications of neoadjuvant chemotherapy for breast cancer
- informed consent has been signed
- Preoperative anesthesia assessment is low to medium risk (ASA score)
Exclusion Criteria:
- There are absolute and relative contraindications of chemotherapy
- Refuse surgery or can't tolerate surgery
- Unable to cooperate or unwilling to place Marker
- Pregnant women
- Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on
- Diabetes patients who are difficult to control
- Excessive smokers
- high risk of anesthesia
- Any serious complications are not suitable for patients participating in this study
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAD ARM
Arm Description
Outcomes
Primary Outcome Measures
False negative rate (FNR) of targeted axillary lymph node resection
False negative rate (FNR) of targeted axillary lymph node resection of breast cancer with methylene blue single tracer after neoadjuvant chemotherapy for T1-3N1M0 breast cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT04744506
First Posted
December 27, 2020
Last Updated
February 3, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04744506
Brief Title
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Official Title
Targeted Resection of Axillary Metastatic Lymph Nodes Guided by Tissue Marker Clip After Neoadjuvant Chemotherapy for Breast Cancer: a Multicenter, Prospective and Self-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a multi-center, prospective, self-controlled study, to evaluate the feasibility of targeted axillary lymph node resection (TAD) guided by tissue marker clip with methylene blue single tracer after neoadjuvant chemotherapy in T1-4N1M0 breast cancer patients. Evaluate the accuracy and false negative rate of TAD, comparing with sentinel lymph node biopsy, and explore a new axillary-preserving mode after neoadjuvant chemotherapy for breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgery, Lymph Node Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
332 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAD ARM
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tissue Marker Clip
Intervention Description
Tissue Marker Clip Placed in Metastatic Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)
Primary Outcome Measure Information:
Title
False negative rate (FNR) of targeted axillary lymph node resection
Description
False negative rate (FNR) of targeted axillary lymph node resection of breast cancer with methylene blue single tracer after neoadjuvant chemotherapy for T1-3N1M0 breast cancer
Time Frame
Up to 60 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0)
accord with the indications of neoadjuvant chemotherapy for breast cancer
informed consent has been signed
Preoperative anesthesia assessment is low to medium risk (ASA score)
Exclusion Criteria:
There are absolute and relative contraindications of chemotherapy
Refuse surgery or can't tolerate surgery
Unable to cooperate or unwilling to place Marker
Pregnant women
Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on
Diabetes patients who are difficult to control
Excessive smokers
high risk of anesthesia
Any serious complications are not suitable for patients participating in this study
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Huang, Dr
Phone
+86 0571 87784642
Email
fhchenwz@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
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