Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744506
• Other study ID #: 2020-535
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: July 15, 2025

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0)

2. accord with the indications of neoadjuvant chemotherapy for breast cancer

3. informed consent has been signed

4. Preoperative anesthesia assessment is low to medium risk (ASA score)

Exclusion Criteria:

1. There are absolute and relative contraindications of chemotherapy

2. Refuse surgery or can't tolerate surgery

3. Unable to cooperate or unwilling to place Marker

4. Pregnant women

5. Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on

6. Diabetes patients who are difficult to control

7. Excessive smokers

8. high risk of anesthesia

9. Any serious complications are not suitable for patients participating in this study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymph Node Metastases
• Surgery

Intervention

Device:
• Tissue Marker Clip
Tissue Marker Clip Placed in Metastatic Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 60 months