TEST:

Oncotype DX Breast Recurrence Score®Test

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.

In node-positive hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer, neoadjuvant chemotherapy is associated with inferior overall survival compared with upfront surgery, particularly among patients with limited nodal burden. However, patients who achieve nodal complete response experience excellent long-term outcomes, supporting careful selection for neoadjuvant treatment.

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

Kaplan-Meier analysis demonstrated that patients classified as low-risk by the model had a significantly better prognosis than those classified as high-risk, with a hazard ratio of 4.1 (P < 0.001) and 2.0 (P < 0.01) on the two external cohorts that include patient outcomes. This artificial intelligence-driven solution offers a rapid, cost-effective, and scalable alternative to genomic testing, with the potential to enhance personalized treatment planning, especially in resource-constrained settings.

Our findings suggest that patients with small tumors and high RS are at a higher risk for LRR than ≤1 cm breast cancers with low RS, despite the best available standard of care treatment. These findings may have important implications for the tailoring of local-regional treatment strategies as they relate to omission of radiotherapy, and selection of radiotherapy modality.

RS testing increased between 2010 and 2023 for both sexes, and RS influenced receipt of chemotherapy. Male patients had higher RS but were less likely to receive chemotherapy when RS ≥ 26, and when chemotherapy was omitted, they had worse OS, revealing the importance of chemotherapy among males with high RS.

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.

P3, N=1520, Recruiting, West German Study Group | Not yet recruiting --> Recruiting

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.

Multivariable analyses revealed that higher nodal burden, high histologic grade, and low progesterone receptor expression independently influenced chemotherapy decision-making despite low genomic risk. These real-world data provide supportive evidence consistent with the RxPONDER findings in a Chinese population; however, given the relatively short follow-up duration, longer-term outcomes are warranted to further substantiate these observations.

IDC-LL demonstrates clinicopathologic and molecular features intermediate between IDC and ILC. Recognition of IDC-LL as a distinct morphologic category is warranted to optimize diagnosis and surgical management.

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