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EUBREAST-01 (GBG 104)

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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 Diachii-Sankyo.

 
 

Information

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.

Status

First Patient in: January 2021.

Trial is recruiting.

Design

EUBREAST-01 is a prospective non-randomized, single-arm surgical trial. Included patients will be recruited for the experimental arm (no axillary SLNB in cases with breast pCR after NAST) exclusively.

Governance

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

Documents

The following trial specific documents are available for download:

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Kontakt

Sponsor, Project management:

EUBREAST-01klnksd-rstckd

Monitoring, Data management:

EUBREAST01gbgd
Fax: +496102 / 7480-440


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