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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Successful rate of the retrieval of the deflector. — Perioperative/Periprocedural
  Number of successful retrieval of the deflector on the total number of surgeries.
• Prevention of Axillary Lymph Node Dissection — 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.

Trial sites (14)

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