TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKliniken Essen-Mitte
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov