To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes

November 26, 2021 updated by: Tao OUYANG, Peking University

To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients

The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC >0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhaoqing Fan, Dr.
  • Phone Number: 8012 +86 88271119
  • Email: zhqfan@yahoo.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital Breast Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • between the age of 18 and 65
  • Eastern Cooperative Oncology Group (ECOG) score 0 or 1
  • pathologically proven positive axillary lymph node
  • enough renal and liver function to sustain chemotherapy
  • informed consent obtained

Exclusion Criteria:

  • inflammatory breast cancer
  • being pregnant or nursing
  • neoadjuvant chemotherapy not planned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wire localization
Intervention: procedure: wire localization
Procedure: wire localization
Pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
Time Frame: through study completion, an average of 1 year
Sensitivity, specificity, false negative rate and negative predictive value will be calculated.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Model to predict lymph node pCR in cN1 patients.
Time Frame: through study completion, an average of 1 year
Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Study Director: Tao Ouyang, Dr., Beijing Cancer hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2018

Primary Completion (Anticipated)

June 20, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

October 13, 2018

First Submitted That Met QC Criteria

October 21, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCP24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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