Targeted removal of a marked lymph node for early hormone-receptor positive breast cancer with limited node spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with T0–T2 ER+/PR+ HER2– breast cancer who have 1–2 suspicious axillary nodes on ultrasound and at least one biopsy-confirmed positive node undergo upfront surgery with targeted axillary dissection, which removes the pre-marked suspicious node plus sentinel lymph node(s). A marker is placed in the most suspicious node preoperatively so that it can be reliably retrieved at surgery and combined with sentinel node review to reduce false negatives. Axillary lymph node dissection is performed only if three or more sentinel nodes are positive, aiming to reduce unnecessary extensive surgery. The protocol follows the latest NCCN guideline criteria to minimize overtreatment while preserving accurate staging.

Why it matters

Who can join: the full rules

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

Where it's running

• AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
  Forlì, Italy, Italy Recruiting
• European Institute of Oncology
  Milan, Italy, Italy Recruiting
• Policlinico San Matteo
  Pavia, Italy, Italy Recruiting
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  Roma, Italy, Italy Recruiting
• IRCCS Humanitas Research Hospital
  Rozzano, Italy, Italy Recruiting
• IRCCS AOU di Bologna - Policlinico di Sant'Orsola
  Bologna, Italy, Italy Not yet recruiting

Study contacts

• Study coordinator: Viviana Galimberti, MD
• Email: viviana.galimberti@ieo.it
• Phone: +39 0257489717

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.