Actively Recruiting
TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Led by Kliniken Essen-Mitte · Updated on 2023-02-15
150
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Female or male patient aged 18 years or older
- Clinical tumor stage T1-4c including bilateral or multifocal breast cancer
- Invasive breast cancer confirmed by core biopsy
- Clinically node positive with 3 or more suspicious lymph nodes
- Biopsy-proven axillary lymph node involvement
- Marking of suspicious lymph node(s) before starting neoadjuvant systemic therapy
- No distant metastases
- Indication for neoadjuvant systemic therapy including chemotherapy
- Planned targeted axillary dissection plus axillary lymph node dissection
- At least 7 lymph nodes planned for histological analysis
You will not qualify if you...
- Clinically node negative or clinically node positive with 2 or fewer suspicious lymph nodes
- No indication for neoadjuvant systemic therapy or therapy duration less than 12 weeks
- Neoadjuvant therapy without chemotherapy
- Adjuvant or neoadjuvant therapy started before study inclusion
- Only axillary lymph node dissection planned
- Clinically node positive status after neoadjuvant therapy
- Recurrent breast cancer
- Prior extensive breast or axillary surgery before study
- Previous radiotherapy to breast or axilla
- Inflammatory breast cancer
- Extramammary breast cancer
- Pregnant women
- Unable to undergo surgery
- Unable to understand or comply with study conditions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kliniken Essen-Mitte (KEM)
Essen, Germany, 45136
Actively Recruiting
Research Team
O
Oliver Halfmann
CONTACT
D
Dorothea Schindowski
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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