EUBREAST-01 (GBG 104)

Omission of sentinel lymph node biopsy in triple-negative and HER2-positive breast cancer patients with radiologic and pathologic complete response in the breast after neoadjuvant systemic therapy: a single-arm, prospective surgical trial.

EUBREAST-01 is supported by the Else Kröner-Fresenius-Foundation and the EUBREAST Network.

• NCT04101851

Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving preoperative systemic therapy (PST), offering the opportunity to de-escalate, and perhaps eliminate, surgery in patients who have a pCR. We propose a clinical trial in which only patients with the highest likelihood of having a pCR after PST will be included and type of surgery will be defined according to the response to PST rather than on the classical T (for tumor size in the breast) and N (for axillary lymph node involvement) status at presentation. In the planned trial, axillary surgery will be eliminated completely (no axillary sentinel lymph node biopsy) for initially clinical node-negative patients with radiologic complete remission and a breast pCR as determined in the lumpectomy specimen.

• Study summary at clinicaltrials.gov (NCT0410185)
• EUBREAST-01 Review in Cancers 2020, 12(12), 3698 (free full access)
  

First Patient in: January 2021.

Trial is recruiting.

Sponsorship and Project management: University of Rostock, Breast Center at Klinikum Suedstadt

Study chairs: Prof. Toralf Reimer (Rostock) and Dr. Oreste Gentilini (Mailand)

Statistician: Edoardo Botteri (San Raffaele Hospital, Mailand and Norwegian Cancer Registry, Oslo)

Data Management and Monitoring: GBG

The following trial specific documents are available for download: