TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Recruiting · NCT05462457 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- signed informed consent form
- female/male patient aged ≥ 18 years
- clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed
- invasive breast cancer confirmed by core biopsy
- clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes
- biopsy-proven axillary lymph node involvement
- marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST
- without distant metastases
- indication for NST including chemotherapy
- TAD + ALND planned
- at least 7 lymph nodes (TAD + ALND) planned for histological analysis
Exclusion criteria
- cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes
- patients without indication for NST or NST \< 12 weeks
- NST without chemotherapy
- adjuvant/ neoadjuvant therapy already started prior to inclusion in the study
- patients for whom only ALND is planned
- ycN+ (by means of axillary ultrasound or other imaging methods)
- recurrent breast cancer
- larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study
- previous radiotherapy of the breast or axilla
- inflammatory breast cancer
- extramammary breast cancer
- pregnant women
- not able to undergo surgery
- inability to understand the purpose of the clinical study or to comply with study conditions
Where it is running
1 location listed.
- Kliniken Essen-Mitte (KEM) - Essen, Germany