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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04744506
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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
Breast Cancer Surgery Lymph Node Metastases Device: Tissue Marker Clip Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 15, 2020
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : July 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. False negative rate (FNR) of targeted axillary lymph node resection [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744506


Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Jian Huang, Dr    +86 0571 87784642    fhchenwz@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
  Study Documents (Full-Text)

Documents provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Study Protocol and Statistical Analysis Plan  [PDF] July 5, 2020
Informed Consent Form  [PDF] July 4, 2020

More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04744506    
Other Study ID Numbers: 2020-535
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphatic Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes