MUltimodal Targeted Axillary Surgery (MUTAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Node-positive Breast Cancer
• Intervention / Treatment: Diagnostic test: Systematic axillary ultrasound imaging; Diagnostic test: Sentinel node; Procedure: Excision of suspicious lymph nodes; Procedure: Two steps axillary node clearance

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Vernet-Tomas, MD, PhD; Phone Number: 34932483132; Email: mvernet@psmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Eli Fite Collet; Email: ufmama@psmar.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Node-positive breast cancer patients; 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; 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.; Diagnostic test: Sentinel node; Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.; Procedure: Excision of suspicious lymph nodes; Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.; Procedure: Two steps axillary node clearance; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: GEICAM
• Investigators: Principal Investigator: Maria Vernet-Tomas, MD, PhD, Parc de Salut Mar

Publications and helpful links

General Publications

• Vernet-Tomas M, Banos N, Sabadell D, Corominas JM, Mestre-Fusco A, Suarez-Pinera M, Carreras R. p53 expression in breast cancer predicts tumors with low probability of non-sentinel nodes infiltration. J Obstet Gynaecol Res. 2015 Jul;41(7):1115-21. doi: 10.1111/jog.12670. Epub 2015 Feb 6.
• Nicolau P, Gamero R, Rodriguez-Arana A, Plancarte F, Alcantara R, Carreras R, Sabadell D, Vernet-Tomas M. Imaging and pathology features to predict axillary tumor load in breast cancer. J Obstet Gynaecol Res. 2018 Feb;44(2):331-336. doi: 10.1111/jog.13490. Epub 2017 Oct 13.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Anticipated): March 15, 2022
• Study Completion (Anticipated): November 15, 2022

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: sentinel node; axillary node clearance; axillary ultrasound imaging; tumor load
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2018/8361/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No