A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer.

ABSTRACT:

Purpose

Axillary surgery is increasingly omitted in patients with early-stage breast cancer undergoing upfront surgery, as supported by trials such as SOUND and INSEMA. However, in the neoadjuvant setting, the omission of axillary surgery has only been explored in small single-arm studies involving highly selected patients with confirmed breast pathologic complete response (pCR). The NeoNAUTILUS trial aimed to evaluate the oncologic safety of omitting sentinel lymph node biopsy (SLNB) in patients with a high probability of achieving an axillary pCR (ypN0) following neoadjuvant systemic therapy (NST), regardless of breast pCR status.

Methods

NeoNAUTILUS is a prospective, multicenter, randomized, controlled, non-inferiority trial conducted at 12 tertiary centers in Korea. Elig

SUBMITTER: Jung JJ 

PROVIDER: S-EPMC12768586 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature