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MUltimodal Targeted Axillary Surgery (MUTAS)

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ClinicalTrials.gov Identifier: NCT04039893
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
GEICAM
Information provided by (Responsible Party):
Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Node-positive Breast Cancer Diagnostic Test: Systematic axillary ultrasound imaging Diagnostic Test: Sentinel node Procedure: Excision of suspicious lymph nodes Procedure: Two steps axillary node clearance Not Applicable

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 intercostobraquial nerve. The trial intends to identify patients for who a complete axillary node clearance could be spared.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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 intercostobraquial nerve will be considered the limit defining the border between superior and inferior axilla.




Primary Outcome Measures :
  1. Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow [ Time Frame: 24 months ]
    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.

  2. Number of patients correctly identified as low axillary tumor load carriers by the information on tumor load of suspicious and sentinel axillary lymph nodes. [ Time Frame: 24 months ]
    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.

  3. 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 [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Number of infiltrated axillary lymph nodes detected by physical exploration [ Time Frame: 24 months ]
    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.

  2. Number of infiltrated lymph nodes detected by computed tomography [ Time Frame: 24 months ]
    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.

  3. Number of infiltrated lymph nodes detected by magnetic resonance [ Time Frame: 24 months ]
    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.

  4. Number of patients with low axillary tumor load among menopause status categories [ Time Frame: 24 months ]
    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).

  5. Number of patients with low axillary tumor load among each breast cancer pathology subtype. [ Time Frame: 24 months ]
    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

  6. Number of patients with low axillary tumor load among each breast cancer inmunophenotype. [ Time Frame: 24 months ]
    The number of patients with low axillary tumor load in each breast cancer inmunophenotypes (luminal , Her2 positive and triple negative carcinomas) will be reported

  7. Number of patients with infiltrated nodes exclusively in the inferior axillary node clearance. [ Time Frame: 24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039893


Contacts
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Contact: Maria Vernet-Tomas, MD, PhD 34932483132 mvernet@psmar.cat

Locations
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Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Eli Fite Collet       ufmama@psmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
GEICAM
Investigators
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Principal Investigator: Maria Vernet-Tomas, MD, PhD Parc de Salut Mar
Publications:
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04039893    
Other Study ID Numbers: 2018/8361/I
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
axillary node clearance
axillary ultrasound imaging
sentinel node
tumor load
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases