Actively Recruiting

Age: 18Years +
All Genders
NCT04373655

AXillary Surgery After NeoAdjuvant Treatment

Led by European Breast Cancer Research Association of Surgical Trialists · Updated on 2025-03-03

3000

Participants Needed

1

Research Sites

517 weeks

Total Duration

On this page

Sponsors

E

European Breast Cancer Research Association of Surgical Trialists

Lead Sponsor

A

AWOgyn

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

AXillary Surgery After NeoAdjuvant Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Primary invasive breast cancer confirmed by core biopsy
  • Clinically positive lymph nodes (cN+)
  • Tumor stage cT1 to cT4c
  • Scheduled for neoadjuvant systemic therapy
  • Female or male patients aged 18 years or older
Not Eligible

You will not qualify if you...

  • Presence of distant metastasis
  • Recurrent breast cancer
  • Inflammatory breast cancer
  • Extramammary breast cancer
  • Supraclavicular lymph node metastasis
  • Pregnancy
  • Less than 4 cycles of neoadjuvant chemotherapy administered
  • Patients not suitable for surgical treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Klinikum Esslingen

Esslingen am Neckar, Germany

Actively Recruiting

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Research Team

T

Thorsten Kühn, Prof.

CONTACT

M

Maggie Banys-Paluchowski, PD Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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