MUltimodal Targeted Axillary Surgery

Study Overview
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Brief Summary
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The present trial will prospectively evaluate the accuracy of both a systematic predefined axillary ultrasound imaging together with tumor load quantification of suspicious and sentinel axillary lymph nodes to predict overall tumor load in the axilla.

Detailed Description
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Axillary node clearance (ANC) is a controversial intervention in the surgical treatment of breast cancer. Different studies have shown that in some patients with infiltrated axillary lymph nodes but low tumor burden, ANC can be safely omitted. However, indications for ANC persist in nowadays for patients with positive axillary lymph nodes and upfront surgery and patients with positive lymph nodes after neoadjuvant treatment. The present prospective study will evaluate the ability to establish an axillary tumor load with two steps. The first step will be a preoperative predefined systematic axillary ultrasound imaging workflow. The second step will be the tumor load evaluation of suspicious and sentinel axillary lymph nodes. We will also evaluate which patients have infiltrated nodes only beneath the second intercostobrachial nerve. The trial intends to identify patients for who a complete axillary node clearance could be spared.

Official Title
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Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.

Conditions
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Node-positive Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Systematic axillary ultrasound imaging
* Diagnostic Test: Sentinel node
* Procedure: Excision of suspicious lymph nodes
* Procedure: Two steps axillary node clearance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Node-positive breast cancer patients confirmed by biopsy or cytology Positivity confirmed before the surgical treatment Exclusion Criteria: Inability to confirm positive lymph nodes by biopsy or cytology Inability to understand the protocol design Poor understanding of the Spanish language

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Node-positive breast cancer patients<br>All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment | Diagnostic Test: Systematic axillary ultrasound imaging<br>* Before surgery, all patients will be explored with a pre-defined systematic and reproducible axillary ultrasound imaging workflow intending to establish the number of neoplastic lymph nodes.<br>Diagnostic Test: Sentinel node<br>* Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.<br>Procedure: Excision of suspicious lymph nodes<br>* Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.<br>Procedure: Two steps axillary node clearance<br>* Axillary node clearance will be performed in two steps comprising inferior and superior clearance. The second intercostobrachial nerve will be considered the limit defining the border between superior and inferior axilla.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow | The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of the pre-defined systematic ultrasound imaging workflow for identifying patients wih low axillary tumor load will be reported. Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes. | 24 months | 
| Number of patients correctly identified as low axillary tumor load carriers by the information on tumor load of suspicious and sentinel axillary lymph nodes. | The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of different tumor load cut-off points of the suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes. | 24 months | 
| Number of patients correctly identified as low axillary tumor load carriers combining both the pre-defined axillary ultrasound imaging workflow with the information on tumor load of suspicious and sentinel axillary nodes | The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of both the pre-defined systematic axillary ultrasound imaging workflow combined with tumor load information of suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infiltrated axillary lymph nodes detected by physical exploration | The difference between the number of positive lymph nodes identified in the final pathology exam and the nodes described as suspicious in physical exploration will be recorded to establish if physical exploration correctly estimates, underestimates or overestimates axillary tumour load. | 24 months | 
| Number of infiltrated lymph nodes detected by computed tomography | The difference between the number of positive lymph nodes identified in the final pathology exam and the nodes described as suspicious in computed tomography will be recorded to establish if physical exploration correctly estimates, underestimates or overestimates axillary tumour load. | 24 months | 
| Number of infiltrated lymph nodes detected by magnetic resonance | The difference between the number of positive lymph nodes identified in the final pathology exam and the nodes described as suspicious in magnetic resonance will be recorded to establish if magnetic resonance correctly estimates, underestimates or overestimates axillary tumour load. | 24 months | 
| Number of patients with low axillary tumor load among menopause status categories | The number of patients with low axillary tumor load in each menopause category will be reported. Patients will be categorized according to their menopausal status (pre-menopause and menopause). | 24 months | 
| Number of patients with low axillary tumor load among each breast cancer pathology subtype. | The number of patients with low axillary tumor load in each breast cancer pathology subtype (non-specified invasive carcinoma, lobular carcinoma and other carcinomas) will be reported | 24 months | 
| Number of patients with low axillary tumor load among each breast cancer immunophenotype. | The number of patients with low axillary tumor load in each breast cancer immunophenotypes (luminal , Her2 positive and triple negative carcinomas) will be reported | 24 months | 
| Number of patients with infiltrated nodes exclusively in the inferior axillary node clearance. | The number of patients with infiltrated nodes exclusively in the inferior axillary node clearance wil be reported. This information shall be obtained from the final pathology report. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor load, axillary node clearance, axillary ultrasound imaging, sentinel node