Prospective Evaluation of Targeted Axillary Dissection (TAD)

Study Overview
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Brief Summary
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The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.

Official Title
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TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Axillary Dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women or men greater than or equal to 18 years. Histologically confirmed invasive adenocarcinoma of the breast. Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition) Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam. Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease. Patients must have biopsy proven involvement of the axillary lymph nodes. Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype. Candidate for surgical management of breast cancer. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Axillary Dissection (TAD)<br>During standard of care (SoC) surgery to remove breast cancer, study participants will undergo a sampling of lymph nodes in the axilla first and then complete removal of axillary lymph nodes under the arm. | Procedure: Axillary Dissection<br>* A surgical procedure that opens the armpit (axilla) to identify, examine, or remove lymph nodes. Axillary dissection will be performed during SoC breast cancer surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False Negative Rate | The false negative rate of targeted axillary dissection after neoadjuvant systemic therapy (NST) in study participants. A false negative event will be defined as a case where the specific node (either the clipped node or the sentinel lymph node, depending on the analysis) does not show metastasis even though residual disease is identified in the other axillary nodes. The false negative rate will be computed as the number of false negative events divided by the total number of pathologically node-positive patients. | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel Lymph Node Identification Rate | The sentinel lymph node identification rate is the number of study participants with at least one sentinel lymph node divided by total number of study participants. | Day 1 (Day of Surgery) | 
| Clipped Lymph Node Identification Rate | The clipped lymph node identification rate is the number of study participants with at least one clipped lymph node removed divided by the total number of study participants with clipped lymph nodes. | Day 1 (Day of Surgery) | 
| Accuracy Rate of Imaging Studies | The accuracy rate of imaging studies in determining response in the breast and axilla will be calculated as the sum of true responders on imaging and true non-responders on imaging divided by total number of study participants. | Up to 2 weeks | 
| Pathologic Complete Response (pCR) | The number of participants with pCR will be reported. The percentage of patients with pCR will be calculated as the number of patients with a pCR divided by the total number of study participants. PCR is defined as the lack of all signs of cancer in tissue samples removed during surgery. | Up to 2 weeks | 
| Incidence of Treatment-Emergent Adverse Events | Number of participants experiencing treatment-emergent adverse events (AEs). AEs will be assessed by and assigned severity and treatment attribution by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. | Up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targeted Axillary Dissection, Advanced Nodal Disease, Axillary Lymph Node