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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neoplasm, Breast, Neoadjuvant Chemotherapy, Lymph Node Metastases, Response

Intervention / Treatment
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* Procedure: wire localization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wire localization<br>Intervention: procedure: wire localization | Procedure: wire localization<br>* 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.<br>|

What is the study measuring?
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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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm, Breast, neoadjuvant chemotherapy, Lymph Node Metastases, response