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Oncotype DX Breast Recurrence Score®Test

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.

Our model accurately predicted recurrence and outcomes across US and Brazilian cohorts, supporting treatment de-escalation in low-risk patients and promoting equitable care where genomic testing is limited.

BRIDGE is a biologically grounded framework for neoadjuvant BC response prediction, validated on a rich set of different patients' cohorts. Its histopathology-based version opens the door for fast and low-cost prediction in the neoadjuvant setting, upon further prospective testing and validation.

Prosigna can help identify young women with stage I-II ER+ /HER2- BC who gain benefit from (neo)adjuvant CT and those in need of further escalated treatments. In premenopausal N0/RI and N1/RL-RI disease, the effect of CT seems to be driven by ovarian function suppression. Prospective validation is required.