TEST:

Oncotype DX Breast Recurrence Score®Test

The need for chemotherapy in postmenopausal HR + , HER2- breast cancer patients might be further informed by integrating the results of the Oncotype DX test with the response to NET.

Ongoing research and technological advancements, such as artificial intelligence-based predictive models and novel biomarker identification, hold significant promise for further enhancing its predictive accuracy and expanding its applications. This review synthesizes current evidence supporting the clinical utility of Oncotype DX, discusses evolving applications, and highlights future directions for integrating this genomic tool into precision oncology practice.

Overall concordance between Ki-67-based proliferation categories and RS-based genomic risk was 56.2%, with discordant cases in both directions. Ki-67 shows a modest association with Oncotype DX RS, but substantial discordance indicates Ki-67 should not substitute genomic testing in HR-positive/HER2-negative early breast cancer.

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

P3, N=1978, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Jul 2026 --> Feb 2027

Approximately one-third of patients who met GEP criteria and were eligible for publicly known reimbursement received a GEP. Appropriate follow-up steps and further research seem required to analyse reasons for not ordering a GEP in times of reimbursement, since GEP results help chemotherapy decision-making.

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.

In selected patients with pT1 breast cancer, omission of axillary nodal status during MDT decision-making may safely reduce adjuvant chemotherapy use without compromising treatment planning, supporting current axillary de-escalation strategies.

P=N/A, N=202, Active, not recruiting, University of Michigan Rogel Cancer Center | Trial completion date: May 2026 --> May 2028 | Trial primary completion date: May 2026 --> May 2028

This review focuses on the utility of the 21-gene assay in patients with HR + HER2-negative early-stage breast cancer in the neoadjuvant setting. It discusses the analytical validation of performing the assay on core biopsies, its clinical validation as a tool to guide neoadjuvant treatment decisions (primary surgery, NET, or NCT), the association of the RS result with clinical outcomes, the impact of the RS results on neoadjuvant treatment decisions in real-life clinical practice, the inclusion of the assay in the neoadjuvant setting in clinical-practice guidelines, access of patients worldwide to this approach, and potential directions for additional studies examining the role of the RS in other steps in the clinical pathway of HR + HER2-negative early-stage breast cancer.

NHB women in the least deprived neighborhoods had the highest prevalence of high-risk ODX RS relative to NHW women in those neighborhoods (PR = 1.92, 95% CI 1.53-2.41). These findings suggest neighborhood deprivation does not explain racial differences in genomic risk.