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

RECRUITINGSponsored by European Institute of Oncology
Actively Recruiting
SponsorEuropean Institute of Oncology
Started2026-01-28
Est. completion2028-11
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 90 YearsHealthy volunteers accepted
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

Conditions5

ALNDBreast CancerCancerSentinel Lymph Node Biopsy (SLNB)Targeted Axillary Dissection (TAD)

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