TEST:

HER2DX

HER2DX reflects key biological and pathological features of HER2+ breast cancer and independently predicts pCR, supporting its utility for individualized treatment decision-making.

HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935.

P=N/A, N=304, Recruiting, Fundacio Clinic Barcelona | Not yet recruiting --> Recruiting

These results suggest that ERBB2 mRNA expression, as measured by HER2DX, may help refine selection for T-chemo and guide more personalized treatment strategies in HER2-positive AGC.

"Reveal Genomics... today announced the publication of the study 'HER2DX and survival outcomes in early-stage HER2-positive breast cancer: an individual patient-level meta-analysis' in The Lancet Oncology.In the most comprehensive analysis to date of the HER2DX genomic test, investigators evaluated its prognostic utility across more than2,500 patients with early-stage HER2-positive (HER2+) breast cancer. Data from 11 international studies, including APT, ATEMPT, CALGB40601, DAPHNe, and PHERGain, were harmonized to assess the ability of HER2DX to stratify long-term risk and inform personalized treatment strategies in both neoadjuvant and adjuvant settings."

HER2DX provides clinically meaningful prognostic stratification in early-stage HER2-positive breast cancer, beyond standard clinical-pathological variables and pathological response. These results support its use in tailoring treatment intensity and guiding clinical decision making.

In advanced HER2-positive breast cancer, the standard taxane-trastuzumab-pertuzumab (THP) regimen faces competition from new therapies, emphasizing the need for biomarkers to guide treatment. Patients with ERBB2-high scores had significantly better median PFS (33.9 vs. 10.6 months, hazard ratio &lsqb;HR] = 0.40, 95% CI: 0.24-0.69, p < 0.001) and OS (not reached vs. 30.8 months, HR = 0.26, 95% CI: 0.13-0.49, p < 0.001) compared to ERBB2-low patients. Based on these findings, further validation of this biomarker in tumor samples from the CLEOPATRA phase III trial is ongoing, which could help optimize treatment strategies in this population.

HER2DX integrates tumor size and nodal involvement with 27 genes' expression data tracking four biological BC-related and immunologic signatures so to estimate a prognostic and a predictive score. This report demonstrates how clinical and genomic data can be effectively integrated to optimize therapeutic decisions in HER2+ BC, offering a model for personalized care also in atypical and complex cases.

The HER2DX pCR score could predict pCR in stage III HER2-positive IBC following treatment with de-escalated neoadjuvant systemic therapy and in stage III HER2-positive non-IBC. Elevated pCR rates in HER2-positive IBC with high HER2DX pCR scores suggest there may be a role for treatment de-escalation in these patients and confirmatory studies are justified.

P=NA | N=9,638 | "This study highlights the clinical value of REVEAL GENOMICS' immune gene combinations, which identify key immune cells such as B-cells and T-cells linked to recurrence, metastasis, and treatment response in HER2-positive (HER2+) and triple-negative breast cancer (TNBC)....Analyzing comprehensive gene expression and clinical data from 9,638 patients across three distinct cohorts, a significant association was observed between immune expression and OS in patients without a documented relapse, independently of cancer subtype, tumor stage, or nodal status. Overall, patients with high immune tumors, characterized by significant immune system activity within its microenvironment, experienced a 41-47% reduction in mortality risk compared to low immune tumors."

While chemotherapy and trastuzumab improve survival in early-stage HER2-positive breast cancer, variability in clinical and biological characteristics leads to different response to therapies and outcomes...Key findings show that HER2DX predicts relapse-free survival and probability of pCR to a variety of neoadjuvant therapy regimens, which aids in personalizing treatment plans that could reduce over-treatment and under-treatment. The article underscores expert recommendations to help integrate HER2DX into clinical practice, aiming to enhance decision making and clinical outcomes.