Impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR-positive/HER2-negative breast cancer: a single-center prospective observational study.

ABSTRACT:

Background

The 50-gene assay Prosigna is cleared by the United States Food and Drug Administration only in postoperative hormone receptor-positive (HR-positive) breast cancer (BC) specimens. Given studies showing that Prosigna may identify chemo-sensitive tumors, this decision-impact study evaluated whether the assay could influence physicians' choices and patients' confidence in the neoadjuvant treatment plan.

Patients and methods

This single-center prospective observational study included patients with early-stage HR-positive/HER2-negative BC measuring ≥0.5 cm, any nodal status, deemed as possible candidates for neoadjuvant treatment per physician's choice. Formalin-fixed, paraffin-embedded core biopsy specimens were centrally analyzed using Prosigna. Physicians and patien

SUBMITTER: Corti C 

PROVIDER: S-EPMC12314373 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature