AXillary Surgery After NeoAdjuvant Treatment

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04373655

Run by

European Breast Cancer Research Association of Surgical Trialists

People needed

3000

Starts

2020-04-28

Expected to finish

2030-04-01

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form
• Primary invasive breast cancer (confirmed by core biopsy)
• cN+
• cT1-4c
• Scheduled for neoadjuvant systemic therapy
• Female / male patients ≥ 18 years old

You may not qualify if…

• Distant metastasis
• Recurrent breast cancer
• Inflammatory breast cancer
• Extramammary breast cancer
• Supraclavicular lymph node metastasis
• Pregnancy
• Less than 4 cycles of NACT administered
• Patients not suitable for surgical treatment

Where it is running

• Klinikum Esslingen — Esslingen am Neckar, Germany (enrolling)

Full record on ClinicalTrials.gov

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