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Recruiting NCT07278726

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upfront Targeted Axillary Dissection (UTAD).
Who it may be relevant to
Registry conditions: ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD). Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Detailed description

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

Interventions

  • Procedure Upfront Targeted Axillary Dissection (UTAD)
    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 outcome measures

  • Successful rate of the retrieval of the deflector. [Time frame: Perioperative/Periprocedural]
  • Prevention of Axillary Lymph Node Dissection [Time frame: Perioperative/Periprocedural]
Secondary outcome measures (1)
  • Axillary recurrence rate [Time frame: 5 years from surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 13 centers
  • IRCCS AOU di Bologna - Policlinico di Sant'Orsola — Bologna
  • AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni — Forlì
  • European Institute of Oncology — Milan
  • Fondazione IRCCS Istituto Nazionale Tumori di Milano — Milan
  • Azienda Ospedaliera Universitaria Federico II — Naples
  • Presidio Ospedaliero "G. Bernabeo" — Ortona
  • Policlinico San Matteo — Pavia
  • Azienda Ospedaliera Universitaria Pisana — Pisa
  • … and 5 more centers
Switzerland · 1 center
  • Ente Ospedaliero Cantonale — Lugano

Identifiers

NCT: NCT07278726 · UID 5132 · L2-439

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗