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NCT Number: NCT07278726

Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement

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.

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Key information

Conditions

ALND Sentinel Lymph Node Biopsy (SLNB) Targeted Axillary Dissection (TAD)

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU di Bologna - Policlinico di Sant'Orsola, Bologna, Italy

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upfront Targeted Axillary Dissection (UTAD)

Procedure

During the surgical intervention lymphnodes excised both with reflector localization and Gamma probe will be sent for pathological examination and only in case of more than 2 metastatic lymph nodes (and at least one of them with macrometastasis) axillary dissection will be performed.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Viviana Galimberti, MD

CONTACT

[email protected]

+39 0257489717

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: UTAD

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Dec 12, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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