Evaluating targeted axillary dissection in breast cancer with multiple suspicious lymph nodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the false-negative rate (FNR) of targeted axillary dissection (TAD) in patients with initially clinically node-positive breast cancer who have three or more suspicious lymph nodes. Following neoadjuvant systemic therapy (NST), patients will undergo TAD and axillary lymph node dissection (ALND) to compare outcomes. The study seeks to determine the effectiveness of TAD as a less invasive surgical option compared to traditional ALND, particularly in patients with high initial lymph node involvement. By analyzing a larger cohort, the study aims to fill a gap in existing research regarding TAD's performance in this specific patient population.

Why it matters

Who can join: the full rules

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's running

• Kliniken Essen-Mitte (KEM)
  Essen, Germany Recruiting

Study contacts

• Study coordinator: Oliver Halfmann
• Email: O.Halfmann@kem-med.com
• Phone: +49201174

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.