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AXillary Surgery After NeoAdjuvant Treatment

NCT04373655 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-03-03

No results posted yet for this study

Summary

The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ → ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.

Conditions

Sponsors & Collaborators

  • AWOgyn

    collaborator OTHER

  • AGO-B

    collaborator UNKNOWN

  • North Eastern German Society of Gynaecological Oncology

    collaborator OTHER

  • GBG Forschungs GmbH

    collaborator OTHER

  • Claudia von Schilling Foundation for Breast Cancer Research

    collaborator UNKNOWN

  • Ehmann-Stiftung Savognin

    collaborator UNKNOWN

  • European Breast Cancer Research Association of Surgical Trialists

    lead NETWORK

Principal Investigators

  • Thorsten Kühn, Prof. · European Breast Cancer Research Association of Surgical Trialists

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2030-04-30
Completion
2030-04-30

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 NCT04373655 on ClinicalTrials.gov