Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment

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.

Systematic axillary ultrasound imaging

Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.

Sentinel node

Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.

Excision of suspicious lymph nodes

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.

Two steps axillary node clearance

Maria Vernet-Tomas, MD, PhD

Eli Fite Collet

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.

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.

MUltimodal Targeted Axillary Surgery

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

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.

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.

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.

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.

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.

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.

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).

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

The number of patients with low axillary tumor load in each breast cancer immunophenotypes (luminal , Her2 positive and triple negative carcinomas) will be reported

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MUltimodal Targeted Axillary Surgery	NCT04039893	Node-positive B...	Systematic axil... Sentinel node Excision of sus... Two steps axill...	18 Years -	Parc de Salut Mar
MUltimodal Targeted Axillary Surgery	NCT04039893	Node-positive B...	Systematic axil... Sentinel node Excision of sus... Two steps axill...	18 Years -	Parc de Salut Mar

Spots Global Cancer Trial Database for excision of suspicious lymph nodes