Node-positive Breast CancerMUTASNCT04039893
MUltimodal Targeted Axillary Surgery
A study testing Systematic axillary ultrasound imaging, Sentinel node and Excision of suspicious lymph nodes in people with Node-positive Breast Cancer, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Node-positive Breast Cancer
- What is being tested?
- Systematic axillary ultrasound imaging, Sentinel node and Excision of suspicious lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2019to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Node-positive breast cancer patients confirmed by biopsy or cytology
- Positivity confirmed before the surgical treatment
Who cannot join
- Inability to confirm positive lymph nodes by biopsy or cytology
- Inability to understand the protocol design
- Poor understanding of the Spanish language
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Eli Fite Collet, ufmama@psmar.cat
About this study
Official title: 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.
Read the 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.
- Conditions
- Node-positive Breast Cancer
- Being tested
- Systematic axillary ultrasound imaging, Sentinel node, Excision of suspicious lymph nodes, Two steps axillary node clearance
- Keywords
- axillary node clearance, axillary ultrasound imaging, sentinel node, tumor load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic axillary ultrasound imagingDiagnostic test
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.
Sentinel nodeDiagnostic test
Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.
Excision of suspicious lymph nodesProcedure or surgery
Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.
Two steps axillary node clearanceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Node-positive breast cancer patients | Other | All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment Receives: Diagnostic Test: Systematic axillary ultrasound imaging; Diagnostic Test: Sentinel node; Procedure: Excision of suspicious lymph nodes; Procedure: Two steps axillary node clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start23 Oct 2019
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Node-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- GEICAM
- Responsible party
- Sponsor
- Investigators
- Maria Vernet-Tomas, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039893
- Sponsor's protocol ID
- 2018/8361/I
- Acronym
- MUTAS
- Status last verified
- Oct 2021
- First submitted
- 19 Jun 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25657069Nicolau 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.
PubMed 29027318
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.
- ClinicalTrials.gov ID
- NCT04039893
- Acronym / sponsor ID
- MUTAS / 2018/8361/I
- Conditions
- Node-positive Breast Cancer
- Keywords
- axillary node clearance, axillary ultrasound imaging, sentinel node, tumor load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- GEICAM
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Node-positive breast cancer patients | Other | Diagnostic Test: Systematic axillary ultrasound imaging, Diagnostic Test: Sentinel node, Procedure: Excision of suspicious lymph nodes, Procedure: Two steps axillary node clearanceAll patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Node-positive breast cancer patients confirmed by biopsy or cytology
- Positivity confirmed before the surgical treatment
Key exclusion criteria (3 listed)
- Inability to confirm positive lymph nodes by biopsy or cytology
- Inability to understand the protocol design
- Poor understanding of the Spanish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic axillary ultrasound imagingBefore 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 | Node-positive breast cancer patients |
| Sentinel nodeSentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein. | Diagnostic test | Node-positive breast cancer patients |
| Excision of suspicious lymph nodesNodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately. | Procedure or surgery | Node-positive breast cancer patients |
| Two steps axillary node clearanceAxillary 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. | Procedure or surgery | Node-positive breast cancer patients |
Primary outcome
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.
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.
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.
7 secondary outcomes
Number of infiltrated axillary lymph nodes detected by physical exploration
Time frame: 24 months
Number of infiltrated lymph nodes detected by computed tomography
Time frame: 24 months
Number of infiltrated lymph nodes detected by magnetic resonance
Time frame: 24 months
Number of patients with low axillary tumor load among menopause status categories
Time frame: 24 months
Number of patients with low axillary tumor load among each breast cancer pathology subtype.
Time frame: 24 months
Number of patients with low axillary tumor load among each breast cancer immunophenotype.
Time frame: 24 months
Number of patients with infiltrated nodes exclusively in the inferior axillary node clearance.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 25657069Vernet-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.
- Background: PubMed 29027318Nicolau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Vernet-Tomas, MD, PhD principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic axillary ultrasound imaging, Sentinel node and Excision of suspicious lymph nodes in people with Node-positive Breast Cancer, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Vernet-Tomas, MD, PhD (34932483132, mvernet@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.