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Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD)

NCT03102307 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 548

Last updated 2021-02-03

No results posted yet for this study

Summary

A downstaging of axillary tumor-spread can be achieved in about 40% of the patients receiving neoadjuvant chemotherapy (NACT). The impact of NACT on loco-regional tumor control has not yet been sufficiently investigated. Moreover the pathologic nodal status after NACT is a strong prognostic marker. Therefore it is most desirable to identify the approximately 40% of patients with pathologic complete response of the axilla, that could be spared from a potentially non beneficial axillary lymph node dissection (ALND). Attempts to identify these patients via sentinel lymph node biopsy (SLNB) after NACT have failed to provide acceptable false negative rates (FNR). The new concept of targeted axillary dissection (TAD) following NACT has shown promising results. Still multiple information about the clinical adoption of this procedure into clinical practice are missing. The SenTa registry trial is designed to assess the clinical implementation of TAD into general practice.

Conditions

  • Early Stage Breast Cancer

Interventions

OTHER

Not suitable for TAD

Registry of the rate of patients not suitable for TAD as initial CNB with clip placement of axillary lymph nodes is not possible and underlying medical contraindications, technical obstacles or miscellaneous reasons why needle biopsy and/or clip labeling of clinically affected lymph nodes cannot be done

PROCEDURE

Suitable for TAD

Registry of surgical outcome measures of targeted resection of the clipped node with optional sentinel node biopsy or axillary lymph node dissection with or without preceding neoadjuvant chemotherapy

Sponsors & Collaborators

  • GBG Forschungs GmbH

    collaborator OTHER

  • Kliniken Essen-Mitte

    lead OTHER

Principal Investigators

  • Sherko Kümmel, MD · Kliniken Essen-Mitte

  • Johannes Holtschmidt, MD · Kliniken Essen-Mitte

  • Thortsen Kühn, MD · Klinikum Esslingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-02-28
Completion
2019-10-01

Countries

  • Germany

Study Locations

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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 NCT03102307 on ClinicalTrials.gov