TEST:

Prosigna™ Breast Cancer Prognostic Gene Signature Assay

For ER+/HER2- early breast cancer, the utility of genomic assays such as Oncotype DX, PAM50, and MammaPrint is discussed, with a focus on chemotherapy selection and the role of CDK4/6 inhibitors, and the role of extended endocrine therapy and adjuvant zoledronic acid. In HER2-positive breast cancer, we examine neoadjuvant therapy with dual HER2 blockade (trastuzumab and pertuzumab), personalized regimens that minimize cardiotoxicity, and the potential of antibody-drug conjugates. For TNBC, the growing role of immunotherapy, dose-dense regimens, and adjuvant capecitabine is reviewed, with a focus on olaparib in BRCA-mutated cases. This review also addresses special populations, including BRCA mutation carriers and premenopausal women, and looks at future trends in systemic therapy, including novel agents, biomarker-driven approaches, and treatment de-escalation strategies.

Its supervised and topology-based design enables finer resolution of disease-related transcriptomic alterations. GEDO offers a robust, interpretable framework for quantifying gene modules' activity, with applications in single and potentially in multi-omics integration.

P2, N=1100, Active, not recruiting, SOLTI Breast Cancer Research Group | Recruiting --> Active, not recruiting

Staining variability and feature space divergence as covariate-level factors jointly account for 80.0% of RPD variance in the most parsimonious multivariate model ([Formula: see text], [Formula: see text]). Although based on a limited number of class-level observations and therefore exploratory in nature, these findings highlight the need for domain generalisation strategies targeting covariate shift, even when specialised FMs are used as feature encoders.

P3, N=3380, Not yet recruiting, UNICANCER

Collectively, our findings indicate that many effective BC biomarkers are components of large, evolutionarily conserved cliques within cell-cycle-associated regions of the PPI network. Finally, based on this MCC-centric approach, we identified 11 novel candidate biomarkers.

Precision diagnostics now encompass next-generation sequencing (NGS)-based comprehensive genomic profiling, enabling identification of actionable alterations such as PIK3CA mutations, HER2 amplification, BRCA1/2 pathogenic variants, and NTRK fusions, each linked to approved therapeutic agents. The purpose of this review is to provide a comprehensive synthesis of current and emerging diagnostic modalities in breast cancer-from population-level screening to individualized molecular profiling-and to examine how integrative, multimodal diagnostic platforms are reshaping clinical decision-making in the era of precision medicine.

P2, N=94, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting

P2, N=96, Recruiting, SOLTI Breast Cancer Research Group | Active, not recruiting --> Recruiting | N=48 --> 96 | Trial completion date: Feb 2026 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Dec 2026

The evolution of genomic assays, including Oncotype DX®, MammaPrint®, Prosigna®, EndoPredict®, and Breast Cancer Index®, along with the collaboration of multidisciplinary teams, signifies a transition toward more customized and effective therapeutic strategies. Our work offers a thorough overview of the advancing strategies in breast cancer management in terms of multigene assay application to the clinical routine, specifically focusing on current evidence, limits and future research directions.

Additionally, CMTs displayed intragroup heterogeneity, where not all tumours within a histopathological category clustered together, indicating that the molecular aspect of CMTs is not necessarily reflected in the pathology. Together, this study highlights the need to develop canine-specific molecular markers based on gene expression, which could enable diagnosis prior to surgical removal of tumours, and ultimately improve treatment strategies and outcomes for dogs with mammary tumours.

Independent validation in the Lancet2005 ER+ cohort confirmed that Luminal prognostic gene sets robustly stratified distant relapse-free survival. Collectively, these subtype-specific consensus signatures integrate tumor cell biology and tumor immune microenvironment features, offering robust prognostic tools with potential for future clinical translation.