TEST:

MammaPrint®

Both MammaPrint and OncotypeDX tests improve identifying candidates for chemotherapy among women with early breast cancer, with broadly equivalent clinical usefulness. The tests should be implemented into existing risk algorithms to maximize their clinical usefulness.

P2, N=64, Recruiting, Shantou Central Hospital | Trial completion date: Dec 2024 --> Dec 2025

P2, N=1260, Recruiting, MedSIR | Active, not recruiting --> Recruiting

This study is the first to establish a CENP-based prognostic model for BC, offering novel biomarkers and potential therapeutic targets for personalized treatment. Additionally, the biological function of the key molecule MMP1 was validated through both in vitro and in vivo experiments.

We demonstrate that optimal efficacy requires biomarker-guided patient selection integrating genetic and TME features, precise sequencing, and a mechanistic understanding of drug-specific immunomodulatory effects. The integration of platform trial designs (I-SPY2, CheckMate-7FL) with composite biomarker algorithms represents a paradigm shift toward precision neoadjuvant immunotherapy, offering a conceptual framework for transforming outcomes in molecularly defined HR+ breast cancer subsets.

P3, N=1520, Not yet recruiting, West German Study Group

Innovative approaches such as liquid biopsy and next-generation sequencing (NGS) enable minimally invasive monitoring and personalized care, especially in advanced disease. Breast cancer pathology is thus a dynamic, integrative discipline central to precision oncology, driven by ongoing technological and molecular advances, and essential to multidisciplinary cancer care.

Prognostic evaluation in the external cohort exhibits significant stratification of distant metastasis risk (HR: 3.14, p-value = 0.0014), underscoring the prognostic power of CPMP. These findings demonstrate the capability of CPMP in MP risk prediction, offering a flexible supplement to genomic risk assessment in early-stage BC.

High HER2 intensity and HER2 intrinsic subtype could be a means for predicting achievement of pCR. The findings indicate the essential role of MP/BP subtyping in the treatment of HER2 + BC.

Multi-gene expression assays have reshaped precision oncology in breast cancer by enabling more individualized therapy and supporting de-escalation strategies. Future integration with multi-omics data, development of novel predictive assays, and expansion of validation in diverse populations are essential to maximize their global clinical utility.

A novel baseline response index combining CCL4 and pRb showed excellent predictive performance and stratified patients by likelihood of clinical benefit, with ctDNA dynamics further refining stratification. These findings support DAL-AI as a promising neoadjuvant option and highlight the value of biomarker-guided strategies for treatment optimization.

49. See the NIHR Funding and Awards website for further award information.