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

NCT05462457 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Targeted 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

Sponsors & Collaborators

  • Kliniken Essen-Mitte

    lead OTHER

Principal Investigators

  • Sherko Kuemmel, Prof. Dr. · Breast Unit, Kliniken Essen-Mitte, Essen, Germany

  • Mattea Reinisch, Dr. · Breast Unit, Kliniken Essen-Mitte, Essen, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2027-03-31
Completion
2032-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462457 on ClinicalTrials.gov