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TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Sponsor: Kliniken Essen-Mitte
Summary
Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated. The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.
Official title: Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2022-03-07
Completion Date
2032-03
Last Updated
2023-02-15
Healthy Volunteers
No
Conditions
Interventions
Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)
Intraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention
Locations (1)
Kliniken Essen-Mitte (KEM)
Essen, Germany