Abstract
Improvements in systemic treatments for breast cancer have increased the rates
of pathologic complete response (pCR) in patients receiving preoperative systemic therapy (PST),
o↵ering 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.