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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with primary breast cancer and ≥ 3 (initially) clinically positive lymph nodes with an indication for NST and in whom TAD + ALND is planned when ycN0 status is achieved after the end of NST.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)
Procedure/SurgeryIntraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
False-negative rate (FNR) of TAD in patients with ycN0 status
The FNR of TAD is calculated as the number of patients with histologically negative TAD lymph nodes (LNs) who were found to have positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.
Time frame
Postoperatively immediately after histopathological evaluation of LNsSecondary outcomes
1
Detection rate of preoperative ultrasound
Preoperative detection rate (DR) of initially marked target lymph nodes (TLNs) on ultrasound images after the end of NST
Time frame
Preoperatively2
Localization of TLNs
Successful localization with e.g. wire, magnetic marker, or reflector clip of the marked TLNs
Time frame
Preoperatively or during NST3
Detection rate of TAD
Successful intraoperative identification of at least one SLN and one TLN, including cases with TLN = SLN
Time frame
At the time of surgery4
Detection rate of target lymph node biopsy (TLNB)
Successful intraoperative identification of TLN(s)
Time frame
At the time of surgerySponsors and contacts
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Source ClinicalTrials.gov