Background: Genomic risk stratification using the 70-gene signature (MammaPrint, MP) is established in Western cohorts but lacks large-scale validation in Chinese patients with early
stage breast cancer (BC). This study aimed to bridge this gap.
Methods: We performed MP testing on tumor samples from 1900 consecutive patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) early stage BC treated.
Associations between MP risk classification and clinicopathological features were analyzed.
Results: MP classified 41.1% of patients as High Risk. MP-High Risk status was significantly associated with higher histological grade, Ki67 index >14%, and lower progesterone receptor (PR)
expression (all p<0.05). Crucially, the proportion of patients exhibiting clinical high-risk/genomic low-risk discordance (defined by clinical parameters vs. MP) was 24% in this Chinese cohort,
closely aligning with the 23% rate observed in the landmark MINDACT trial.
Practice Impact: This validation confirms MP's utility in refining risk stratification within the Chinese population, providing critical genomic information to guide personalized adjuvant therapy decisions and potentially spare low-genomic-risk patients from overtreatment.
Discussion: This represents the first large-scale validation of the MammaPrint assay in a Chinese BC cohort, successfully filling a critical data gap and supporting its clinical applicability for
precision oncology in this population.