NCT05071911

Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

Feasability Study of a New Technique of Axillary Evaluation in Patients With Node Positive Breast Cancer Following Neo-adjuvant Chemotherapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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, the investigators see a nodal complete pathological response (ypN0). In certain subgroups, triple negative breast cancer and Her2 amplified breast cancer, this percentage is even higher. The investigators would like to lessen surgical morbidity by performing a targeted axillary dissection. The investigators place a clip in the biopsy-proven lymph node metastasis at diagnosis. After NAC, the investigators perform a dual agent sentinel node procedure and remove the clipped node during the same surgery. When these lymph nodes are microscopically tumor-free, the investigators can abolish an ALND. Targeted axillary dissection after NAC for cN1 disease seems to have acceptable false negative rates in previous trials. The investigators would like to further define patients where an ALND can be safely omitted.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	TAD (Targeted Axillary Dissection)	Dual agent SLNB + resection of proven lymph nodes metastasis marked with clip at diagnosis

Timeline

• Start date: 2021-04-21
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-10-08
• Last updated: 2023-11-07

Locations

1 site across 1 country: Belgium