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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04744506
Collaborator
(none)
332
Enrollment
1
Location
1
Arm
56
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tissue Marker Clip
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
332 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAD ARM

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

Outcome Measures

Primary Outcome Measures

  1. False negative rate (FNR) of targeted axillary lymph node resection [Up to 60 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04744506
Other Study ID Numbers:
  • 2020-535
First Posted:
Feb 9, 2021
Last Update Posted:
Feb 9, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Lymphatic Metastasis

Study Results

No Results Posted as of Feb 9, 2021