TEST:

Prosigna® Breast Risk of Recurrence (ROR) Test

P3, N=1556, Suspended, Alliance for Clinical Trials in Oncology | N=1156 --> 1556

PDZK1 functions as a regulator of HER2 stability and may serve as a potential biomarker and therapeutic target in HER2-positive breast cancer. Pharmacological upregulation of PDZK1 may represent a promising combinatorial therapeutic strategy for overcoming therapeutic resistance in breast cancer.

Multi-platform and multi-omics profiling in this large unique cohort of longitudinal TNBC samples revealed distinct patterns of expression and dynamic changes of key biomarkers of interest for targeted therapies. Given variability with manual IHC scoring, improved methods for quantification of expression may help optimize treatment selection in an individualized manner.

We established a low-ITH subtyping framework that overcomes the limitations of single-biopsy-based molecular typing. Our findings offer a novel strategy to enhance the precision of breast cancer management.

This study uncovers environmental mutagenesis as a previously overlooked but critical driver of luminal breast cancer heterogeneity in East Asian patients. We establish a proteogenomics-transformative scheme to guide risk stratification and subtype-specific vulnerabilities, offering a precision oncology strategy for early-stage East Asian breast cancer management.

A lineage-aware GAN framework yields compact, interpretable signatures that capture ecosystem-level biology (immune activity, ECM remodeling, epithelial plasticity) and can be projected into TCGA-BRCA for subtype-aware prognostic stratification in breast cancer.

The cuproptosis-based risk score model effectively predicts NAC response and may guide personalized treatment in BC. It also reveals the relevance of cuproptosis-related genes in immune modulation and chemotherapy sensitivity.

''Veracyte, Inc...announced today results from the independent OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) trial, led by University College London (UCL). The results, which will be presented at the ASCO Annual Meeting, conclude that the Prosigna® Breast Risk of Recurrence (ROR) test safely guides adjuvant chemotherapy decisions in patients with early-stage, ER-positive HER2-negative breast cancer.''

P1/2, N=117, Completed, Cantargia AB | Active, not recruiting --> Completed

Prosigna can help identify young women with stage I-II ER+ /HER2- BC who gain benefit from (neo)adjuvant CT and those in need of further escalated treatments. In premenopausal N0/RI and N1/RL-RI disease, the effect of CT seems to be driven by ovarian function suppression. Prospective validation is required.

The CDK4/6 inhibitors abemaciclib and ribociclib have set new standards for high-risk HR+/HER2-/early breast cancer. Molecular subtyping (PAM50), RB1 assessment, PR status, germline BRCA testing, and multidisciplinary tumor board review are mandatory. Dedicated prospective trials with ER-low as a pre-specified stratum are urgently needed.

CorePAM-a 24-gene PAM50-derived score-met the pre-specified ΔC-index non-inferiority criterion relative to a 50-gene Cox elastic-net comparator in derivation and retained prognostic discrimination across four external RNA-seq and microarray cohorts, remained significant after anatomical staging adjustment, and was associated with pCR in secondary neoadjuvant analyses. This reduction from 50 to 24 genes may simplify future assay development, although platform-specific analytical validation is required before clinical deployment.