EUBREAST 18 (R) – PRimary Occult Breast cancer and Axillary Metastasis Registry: PROBAMUS

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Future EUBREAST Trial – More information to follow

Project Overview

PI: Prof. Maria Luisa Gasparri

Project Supporters: OPBC

Rationale: European guidelines recommend an axillary dissection, but offer no definitive consensus on whether mastectomy  or whole breast irradiation should be the preferred local treatment for the breast compartment.

Background:  Data collection and analysis are still needed to prove (or disprove) the current management of  patients presenting with axillary metastases from occult breast cancer. Recommendations come from a limited number of retrospective studies involving small numbers of patients. Some large data sets for population-based analysis such as SEER or National Cancer Databases try to draw some conclusions but  there are considerable limitations to using these data, being collected for an epidemiological purpose other than the intended use, therefore data may lack the necessary quality controls and level of detail for the secondary use.

Study design: International multicenter retrospective analysis.

Eligibility: T0, N+ (N1-N3), M0 breast cancer with MRI/CESM  included in the workup, diagnosed and treated in the last 15 years.

Study groups:

  • group 1, patients undergoing ALND with mastectomy
  • group 2, patients undergoing ALND with whole breast RT
  • group 3, patients undergoing ALND and breast observation
  • group 4, patients undergoing NACT

Primary outcome:

  • Local recurrence-rates per group stratified for cN1 vs cN2-3

Secondary outcomes:

  • PFS and OS stratified for cN1 vs cN2-3
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