Validation of TAD in HER-2 with More Than 2 Lymph Nodes

Condition(s) studied

Investigational drug(s) / intervention(s)

Targeted axillary dissection and subsequently a lymphadenectomy: Selective sentinel lymph node biopsy is performed, along with biopsy of the node marked at diagnosis. Subsequently, a lymphadenectomy is performed, with the three samples separated for pathological study during the same surgical procedure

Study summary

The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis. After receiving adequate oncological treatment and axillary assessment by ultrasound for complete radiological response, DAT and Berg level I and II lymphadenectomy will be performed to assess false negatives and positives, as well as their sensitivity and specificity.

Eligibility

Primary outcome measure(s)

• Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity — From enrollment to the end of treatment at 12 months
  Determining the number of positive and negative nodes in targeted axillary dissection and axillary lymphadenectomy

Trial sites (1)

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