TEST:

Oncotype DX Breast Recurrence Score®Test

P3, N=1520, Not yet recruiting, West German Study Group | N=1050 --> 1520

We observed similar ET-response rates in two large phase III trials. Postmenopausal patients (mostly receiving AI) had higher ET-response rates compared to younger patients. However, young patients with GnRH+AI had ET-response rates comparable to postmenopausal patients, suggesting that therapy rather than biology accounts for the difference. Combining ET-response and gene expression assessment could help more luminal eBC patients avoid chemotherapy.

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.

Therefore, the lack of details regarding the timing of the MRI and possible treatment effects constitutes a limiting factor in terms of the internal validity of the model and the clinical interpretation of the findings. Additionally, although almost all patients (99.8%) in the study were reported to have received endocrine therapy, establishing a relationship between BPE and BPE based on the type or response to treatment could strengthenthe study.

P3, N=1670, Recruiting, NRG Oncology | Trial primary completion date: Apr 2026 --> Apr 2031

As the signature relies exclusively on IHC, it is simple, cost-effective and readily integratable into routine diagnostic workflows. In addition to its prognostic value, several biomarkers within the panel are potentially actionable, offering opportunities to guide targeted therapies in patients predicted to have poor response to conventional chemotherapy.

The BCT Gene Score exhibits independent prognostic utility and complements the original BCT Score. Risk stratification may be enhanced by incorporating both scores, ultimately guiding more precise treatment decisions in ER+/HER2- early breast cancer.

Continued effort to address these barriers and improve AI reliability are crucial. Emerging AI tools, including agent-driven systems, point towards the potential integration of CP into routine clinical workflow practice, even though clinical validation has not yet been established.

ER-Predict represents a robust assay with potential utility in early stage HR-positive/HER2-negative breast cancer. Its consistent ability to identify high-risk patients supports further investigation as a decision-support tool to guide treatment intensification in clinically low-risk HR-positive/HER2-negative disease.

Among patients ≥65 years of age who underwent BCS for early-stage estrogen-receptor positive breast cancer, Oncotype DX RS did not further refine recurrence risk estimates for radiotherapy decision-making beyond the findings of landmark radiotherapy omission trials. While the number of patients with Oncotype DX RS > 25 who omitted radiotherapy was limited in this study, this subgroup did not exhibit a significantly higher risk than their low-molecular-risk counterparts, suggesting that risk score need not necessarily disqualify select patients who seek to forego adjuvant radiotherapy. Prospective analyses with larger sample sizes will further elucidate the role of molecular assays in guiding radiotherapy decision making across risk strata.

NPI, using a threshold of 3.4 as recommended by NICE, may assist in identifying patients for whom Oncotype DX testing could be considered. Ki-67 may provide additional prognostic context when interpreted alongside NPI. These markers may contribute to broader risk stratification frameworks but should be viewed as complementary to genomic testing.