MUltimodal Targeted Axillary Surgery (MUTAS)

Parc de Salut Mar

Status: Unknown

Conditions: Node-positive Breast Cancer

Treatments: Procedure: Excision of suspicious lymph nodes; Diagnostic Test: Systematic axillary ultrasound imaging; Diagnostic Test: Sentinel node; Procedure: Two steps axillary node clearance

Study type: Interventional

Funder types: Other

Identifiers

NCT04039893

2018/8361/I

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Node-positive breast cancer patients

Other group

Description:

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

Treatment:

Procedure: Two steps axillary node clearance

Diagnostic Test: Sentinel node

Diagnostic Test: Systematic axillary ultrasound imaging

Procedure: Excision of suspicious lymph nodes