TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes

Recruiting now

Conditions studied: Breast Cancer, Node-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT05462457

Run by

Kliniken Essen-Mitte

People needed

150

Starts

2022-03-07

Expected to finish

2032-03-01

Last updated by the study team

2023-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Kliniken Essen-Mitte (KEM) — Essen, Germany (enrolling)

Full record on ClinicalTrials.gov

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