Prognostic value of EndoPredict test in patients with hormone receptor positive, human epidermal growth factor receptor 2-negative primary breast cancer screened for the randomized, double-blind, phase III UNIRAD trial

We are excited to share findings from a recently published analysis exploring the prognostic value of EndoPredict using prospectively collected data from node-positive ER+ HER2- breast cancer patients screened for the randomized, double-blind, phase III UNIRAD trial.¹

Patients categorized as EndoPredict low- or high-risk were closely monitored for recurrence and survival outcomes in this pre-planned exploratory sub-analysis.

Key Study Findings:

• ​Of the 767 clinically high-risk pre- and postmenopausal patients included, 662 (86%) were classified as high-risk and 105 (14%) as low-risk using EndoPredict.
• The 5-year distant metastasis free survival (DMFS) rate was 100% for the low-risk group, compared to 94% for the high-risk group (p<0.0001).
• The 5-year disease-free survival (DFS) rate was 100% for the low-risk group and 93% for the high-risk group. Patients with EndoPredict results indicating very high-risk, experienced a 5-year recurrence rate of 13% despite chemotherapy.
• EndoPredict was a significant independent prognostic factor for disease-free survival (DFS), even after adjusting for clinicopathological variables.

These results affirm EndoPredict’s role as a reliable prognostic parameter for node-positive, ER-positive, HER2-negative early breast cancer patients undergoing standard adjuvant treatment.

“Identification of a very high-risk population underscores the relevance of our findings for informing adjuvant interventions, particularly chemotherapy and emerging targeted therapies,” commented Frederique Penault-Llorca. “Our prospective series further reinforce the notable lack of events in the low-risk group, prompting consideration for treatment de-escalation strategies for this patient cohort.“

Highlights:

1. Prognostic power: EndoPredict effectively distinguished between high and low-risk patients, with no recurrence observed in the low-risk group over a 5-year period.
2. LoE1A data: This sub-analysis provides Level of Evidence 1A data, affirming EndoPredict’s efficacy in evaluating node-positive early breast cancer. EndoPredict stands out as the only second generation breast cancer recurrence test with Phase III data.
3. Reliability: Study findings confirm data from the prospective-retrospective GEICAM validation², underscoring the reliability and consistency of EndoPredict’s performance in closely matched cohorts treated with chemotherapy.

We believe that these compelling findings underscore the role of EndoPredict in guiding personalized treatment decisions and optimizing patient outcomes.

We encourage you to explore the full study for deeper insights or to review our clinical summary.

What is EndoPredict?

EndoPredict is a prognostic and predictive test combining molecular and clinical factors that provides individualized results, allowing you to make confident decisions about adjuvant chemotherapy and the possibility to stop endocrine therapy after 5 years in ER+/HER2-early-stage breast cancer.

EndoPredict gives clear results and actionable insights for treatment decisions:

1. Distant recurrence risk within years 0–10³
2. Absolute individualized chemotherapy benefit at 10 years⁴
3. Late distant recurrence risk up to 15 years⁵

Gain timely access to genomic insights fostering a pathway to better patient outcomes.

EndoPredict is provided by Myriad Genetics, committed to improving timely access to genomic insights, through local testing, education and partnerships.

For more information about EndoPredict® and its impact on tailored treatment decisions, please check the white paper.

References:

1. Penault-Llorca F. et al. ESMO Open 2024
2. Martin M. et al. Breast Cancer Res. 2014
3. Filipits M. et al. Clin. Cancer Res. 2011
4. Sestak I. et al. Breast Cancer Res Treat. 2019
5. Filipits M. et al. Clin Cancer Res. 2019