Clinical trial NCT04039893: MUltimodal Targeted Axillary Surgery
Official title: Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Node-positive Breast Cancer
Keywords: axillary node clearance
axillary ultrasound imaging
sentinel node
tumor load
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: GEICAM
First posted: 2019-07-31
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow
timeFrame: 24 months
measure: Number of patients correctly identified as low axillary tumor load carriers by the information on tumor load of suspicious and sentinel axillary lymph nodes.
timeFrame: 24 months
measure: 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
timeFrame: 24 months
Secondary outcomes:
measure: Number of infiltrated axillary lymph nodes detected by physical exploration
timeFrame: 24 months
measure: Number of infiltrated lymph nodes detected by computed tomography
timeFrame: 24 months
measure: Number of infiltrated lymph nodes detected by magnetic resonance
timeFrame: 24 months
measure: Number of patients with low axillary tumor load among menopause status categories
timeFrame: 24 months
measure: Number of patients with low axillary tumor load among each breast cancer pathology subtype.
timeFrame: 24 months
measure: Number of patients with low axillary tumor load among each breast cancer immunophenotype.
timeFrame: 24 months
measure: Number of patients with infiltrated nodes exclusively in the inferior axillary node clearance.
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar
name: Maria Vernet-Tomas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.