TEST:

Oncotype DX Breast Recurrence Score®Test

P3, N=2138, Active, not recruiting, Canadian Cancer Trials Group | Recruiting --> Active, not recruiting

In the context of contemporary adjuvant treatment, with patients diagnosed within three years postpartum more likely to receive chemotherapy, ovarian function suppression, and CDK4/6 inhibitors, differences in IDFS associated with time since last childbirth did not result in significantly worse IDFS within the follow-up period (89.0% in patients with PPBC up to 3 years vs. 93.7% in all other patients p = 0.39). These findings indicate that tumors diagnosed within the first year postpartum have significantly elevated RS, and that the period of most aggressive PPBC, as reflected by gene expression profiles, may arise in the more recently postpartum period, in the first 0-3 years postpartum.

P2, N=53, Active, not recruiting, Abramson Cancer Center at Penn Medicine | Trial completion date: Jan 2026 --> Jan 2027

Real-world data demonstrate that ODRS correlates with key pathological characteristics and can guide adjuvant therapy selection, independent of menopausal status or nodal involvement. This suggests that ODRS is useful in tailoring chemotherapy decisions in ER-positive/HER2-negative breast cancer.

There is a need for a cost-effective, rapid, and increasingly accessible alternative to the 21-gene assay for predicting recurrence risk in ER+/HER2- breast cancer. The intratumoral heterogeneity score demonstrated potential as a noninvasive, intuitive, and quantitative biomarker for characterizing intratumoral heterogeneity and predicting recurrence score.

P3, N=950, Recruiting, Tokyo Women's Medical University

Sensitivity analyses using contemporary cutpoints yielded concordant findings. These findings support consistent prognostic value of Oncotype DX assay across racial groups, although further investigation into socioeconomic and clinical contributors to disparities is warranted.

In our randomised, Intermediate RS cohort treated with chemotherapy we observe an association between higher stromal tumour-infiltrating CD8+ lymphocyte (sTIL CD8+) density and poor outcome (ΔLR-χ2: 6.79, p = 0.009), which we validate using data from whole-resection specimens (ΔLR-χ2: 8.90, p = 0.003). Our data thus provide insights into the immune states in ER+HER2- breast cancer, and propose sTIL CD8+ density as candidate biomarker for treatment decisions.

Receptor discordance between primary tumors and nodal metastases is common, with most shifts occurring within the HER2-spectrum. There was a trend toward higher RS and ER or HER2-receptor discordance. HER2 discordance was also associated with larger tumor size and larger size of nodal metastasis. As strategies emerge to target HER2-low cohorts and to include ER-low/HER2-negative disease within treatment regimens for TNBC, it may become important to consider receptor testing of nodal disease in the future.

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.