RecruitingNCT05462457

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

Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)

Sponsor

Kliniken Essen-Mitte

Enrollment

150 participants

Start Date

Mar 7, 2022

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Node-positive Breast Cancer

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical technique called TAD (targeted axillary dissection) — which removes only the specific lymph nodes marked before treatment — in breast cancer patients who start with 3 or more suspicious lymph nodes and then receive chemotherapy before surgery. The goal is to reduce lymph node removal while staying safe. **You may be eligible if...** - You are 18 or older with confirmed invasive breast cancer - You have 3 or more clinically suspicious lymph nodes detected by imaging or biopsy - You are receiving chemotherapy before surgery (neoadjuvant treatment) - A marked lymph node biopsy was performed **You may NOT be eligible if...** - You have distant metastases (cancer spread beyond the breast and lymph nodes) - You are not receiving pre-surgery chemotherapy - The lymph node clip/marker cannot be placed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETargeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)

Intraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention

Locations(1)

Kliniken Essen-Mitte (KEM)

Essen, Germany

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NCT05462457

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