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Clinical Trial Summary

Currently most breast cancer patients with confirmed axillary lymph node metastasis (cN1) at diagnosis are candidates for neoadjuvant chemotherapy (NAC). The increased utilization of NAC can be attributed to practical clinical advantages. The increasing use of NAC has, however, introduced questions regarding appropriate loco-regional management, including the optimal surgical approach to the axillary lymph nodes. According to current guidelines, patients presenting with cN1 disease and treated with NAC, still undergo axillary lymph node dissection (ALND). In forty percent of these patients, however, we see a nodal complete pathological response (ypN0). In certain subgroups, triple negative breast cancer and Her2 amplified breast cancer, this percentage is even higher. We would like to lessen surgical morbidity by performing a targeted axillary dissection. We place a clip in the biopsy-proven lymph node metastasis at diagnosis. After NAC, we perform a dual agent sentinel node procedure and remove the clipped node during the same surgery. When these lymph nodes are microscopically tumor-free, we can abolish an ALND. Targeted axillary dissection after NAC for cN1 disease seems to have acceptable false negative rates in previous trials. We would like to further define patients where an ALND can be safely omitted.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05071911
Study type Observational
Source Universitair Ziekenhuis Brussel
Contact Ine Luyten, MD
Phone +32 2 477 9398
Email [email protected]
Status Recruiting
Start date April 21, 2021
Completion date June 2024

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