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TAD in Primary Breast Cancer With Initially โ‰ฅ 3 Suspicious Lymph Nodes

Recruitingn/aAges 18 Years - anyAllKliniken Essen-Mitte
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In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ 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 โ‰ฅ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * signed informed consent form * female/male patient aged โ‰ฅ 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 โ‰ฅ 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 โ‰ค 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
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What it tests

  • Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)
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Where

1 site
Kliniken Essen-Mitte (KEM)
Essen, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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