TEST:

EndoPredict®

49. See the NIHR Funding and Awards website for further award information.

P2, N=70, Recruiting, Criterium, Inc. | Trial completion date: Dec 2027 --> Dec 2028

Patients randomly received 16 weeks of endocrine therapy (letrozole for post-menopausal and tamoxifen plus ovarian function suppression for pre/peri-menopausal patients) plus palbociclib or placebo. Permanent treatment discontinuation by adverse events was reported for 7 (9.7%) and 0 patients in the palbociclib and placebo arm, respectively. In conclusion, the addition of palbociclib to NET did not improve the efficacy.

P2, N=120, Active, not recruiting, Laura M. Spring, MD | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Aug 2027 | Trial primary completion date: Jun 2024 --> Aug 2025

Both the derivation and validation models showed accurate calibration. In conclusion, the EndoPredict-Px score accurately and early predicted in-hospital mortality in patients with left-sided infective endocarditis.

Here, we review the published data on the most common gene expression signatures (MammaPrint (MP), BluePrint (BP), Oncotype Dx, PAM50, the Breast Cancer Index (BCI), and EndoPredict (EP)) and their ability to predict the response to neoadjuvant treatment, as well as the possibility of using them on core needle biopsies. Additionally, we review the changes in the gene expression signatures after neoadjuvant treatment, and the ongoing clinical trials related to the utility of gene expression signatures in the neoadjuvant setting.

The 10-gene risk score can serve as a tool to predict recurrence risk in HR+/HER2- EBC patients following C-ET, assisting clinicians in developing personalized treatment plans for high-risk patients and ultimately improving patient prognosis.

Integrating CR with the Ki-67 index improves prognostic accuracy and provides a cost-effective alternative to the EP test for luminal-type early breast cancer.

Moreover, the implementation of Molecular Tumor Boards further enhances personalized treatment strategies, contributing to improved patient outcomes and survival rates. This review underscores the significance of tailored therapeutic approaches and highlights the dynamic evolution of breast cancer in clinical practice.

While multiple gene expression profiling tests are available, they classify patients differently and are not interchangeable; therefore, their application should be at the clinician's discretion during the decision-making process. It is essential that these tests are not the sole factor in determining the best treatment plan: other clinical considerations and patient preferences should also play a significant role in guiding treatment decisions.

P2, N=1100, Recruiting, SOLTI Breast Cancer Research Group | Trial completion date: Jul 2030 --> Dec 2031 | Trial primary completion date: Aug 2028 --> Oct 2029

All four tests have prognostic ability in LN+ patients. Evidence on predictive benefit is weaker, with equivocal evidence that Oncotype DX may predict chemotherapy benefit in LN+ post-menopausal patients. Use of Oncotype DX leads to fewer patients being recommended chemotherapy.