Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement (UTAD)

June 15, 2026 updated by: European Institute of Oncology

Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)

The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients that will avoid axillary lymph node dissection (ALND) meet all the criteria listed in the latest NCCN guidelines version.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Italy
      • Bologna, Italy, Italy, 40138
        • Not yet recruiting
        • IRCCS AOU di Bologna - Policlinico di Sant'Orsola
        • Contact:
        • Principal Investigator:
          • Marco Bernini, MD
      • Forlì, Italy, Italy, 47121
        • Recruiting
        • AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
        • Principal Investigator:
          • Annalisa Curcio, MD
        • Contact:
      • Milan, Italy, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:
        • Principal Investigator:
          • Viviana Galimberti, MD
      • Milan, Italy, Italy, 20133
        • Not yet recruiting
        • Fondazione IRCCS Istituto Nazionale Tumori di Milano
        • Contact:
        • Principal Investigator:
          • Massimiliano Gennaro, MD
      • Naples, Italy, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:
          • Nicola Rocco, MD
          • Phone Number: +39 0817462896
      • Ortona, Italy, Italy, 66026
        • Not yet recruiting
        • Presidio Ospedaliero "G. Bernabeo"
        • Contact:
        • Principal Investigator:
          • Simona Grossi, MD
      • Pavia, Italy, Italy, 27100
        • Recruiting
        • Policlinico San Matteo
        • Contact:
        • Principal Investigator:
          • Angelica Della Valle, MD
      • Pisa, Italy, Italy, 56100
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
        • Principal Investigator:
          • Matteo Ghilli, MD
      • Roma, Italy, Italy, 00184
        • Not yet recruiting
        • AO San Giovanni Addolorata
        • Contact:
        • Principal Investigator:
          • Lucio Fortunato, MD
      • Roma, Italy, Italy, 00136
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Gianluca Franceschini, MD
      • Rozzano, Italy, Italy, 20089
        • Recruiting
        • Irccs Humanitas Research Hospital
        • Contact:
        • Principal Investigator:
          • Damiano Gentile, MD
      • Trieste, Italy, Italy, 34148
        • Not yet recruiting
        • Azienda sanitaria universitaria Giuliano Isontina
        • Contact:
        • Principal Investigator:
          • Serena Scomersi, MD
      • Varese, Italy, Italy, 21100
        • Not yet recruiting
        • ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
        • Contact:
        • Principal Investigator:
          • Corrado Chiappa, MD
  • Switzerland
    • Switzerland
      • Lugano, Switzerland, Switzerland, CH-6500
        • Not yet recruiting
        • Ente Ospedaliero Cantonale
        • Contact:
        • Principal Investigator:
          • Nickolas Peradze, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with T0-T1-T2 ER+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 positive nodal citology/histology) M0 for whom neoadjuvant treatment is not recommended after a multidisciplinary discussion, between 18 and 90 years old willing and able to follow the study procedures and available for follow-up over the entire duration of the study.

Description

Inclusion Criteria:

  • Diagnosis of T0-T1-T2 ER+/PR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology/histology)
  • M0
  • Conservative surgery or mastectomy
  • Neoadjuvant treatment not recommended after a multidisciplinary discussion
  • Patients between 18 and 90 years old
  • Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study

Exclusion Criteria:

  • Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study
  • Personal history of invasive breast cancer
  • Other invasive malignancies diagnosed in the last five years
  • Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion
  • Contraindications to radiation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successful rate of the retrieval of the deflector.
Time Frame: Perioperative/Periprocedural
Number of successful retrieval of the deflector on the total number of surgeries.
Perioperative/Periprocedural
Prevention of Axillary Lymph Node Dissection
Time Frame: Perioperative/Periprocedural
Total number of patient that did not received but were elegible for Axillary Lymph Node Dissection by the current guidelines on the total number of surgeries.
Perioperative/Periprocedural

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Axillary recurrence rate
Time Frame: 5 years from surgery.
The secondary endpoint is the rate of axillary recurrence in patients undergoing UTAD and who avoid AD. Cumulative incidence of axillary recurrence as first event will be calculated, considering the following events as competing: distant metastases, death, second primary malignancies, invasive ipsilateral tumor recurrences in the breast or chest wall, supraclavicular or internal mammary recurrences, and contralateral invasive cancers.
5 years from surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UID 5132
  • L2-439 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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