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.
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.
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: