EndoPredict breast cancer testing

 
 

Recurrence Risk at 10 years

Independently Validated For Robust Prognostic Results

EndoPredict was developed using consistent criteria for patients during training and independent validation studies: patients with ER+, HER2- breast cancer, both node negative (N0) or node positive (N+). These “clean” (solely ER+, HER2-) cohorts are one reason for the test’s stronger performance compared to tests that included HER2+ patients in their training cohorts. The score and the cutoff value are consistent in all studies and have never changed.

EndoPredict training and validation studies
The patients in the ABCSG6, ABCSG8 and TransATAC studies were treated with endocrine therapy alone. The prognostic value of EndoPredict under chemotherapy was demonstrated by the GEICAM/9906 study. All patients received only 5 years of endocrine therapy.

Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin Cancer Res. 2011;17(18):6012-6020
Buus R. et al.: Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10;108(11)
Martin M. et al.: Clinical Validation of the EndoPredict Test in Node-Positive, Chemotherapy-Treated ER+/HER2- Breast Cancer Patients: Results from the GEICAM 9906 Trial. BCR. 2014;16:R38

Large Low Risk Group

In all validation studies, EndoPredict identified a large true low risk group in all patients including N+ of up to 65% with a risk of recurrence within 10 years of less than 6%.

Analysis of patients with ER+, HER2- Breast Cancer from ABCSG-6, ABCSG-8, and TransATAC studies

EndoPredict consistently identifies a high percentage of patients with a low risk of recurrence

Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin Cancer Res. 2011;17(18):6012-6020
Buus R. et al.: Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10;108(11)

Clear Risk Groups In Different Subgroups

EndoPredict supplies additional prognostic information to supplement common prognostic factors such as nodal status, tumor grade or Ki67. This has been demonstrated in four validation studies.

Risk Assessment Independent From Nodal Status

In validation studies, 78% of node negative patients were identified as low risk, but 22% were classified as high risk with a need for more aggressive therapy. In node positive patients, EndoPredict identified up to 30% low risk patients who could forego chemotherapy.

Analysis of patients with ER+, HER2- breast cancer from both ABCSG-6 and ABCSG-8 studies

Filipits et al.: Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2- Node- Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only. Clin Cancer Res. 2019;25:3865-3872

Risk Assessment Independent From Grading

EndoPredict identifies high and low risk patients independent from tumor grade. In validation studies, 22% of patients with grade 1 tumors were identified as high risk and 19% of patients with grade 3 tumors as low risk. In the grade 2 group, EndoPredict classified 60% of patients as low risk with a recurrence risk of less than 10%.

Analysis of patients with ER+, HER2- breast cancer from both ABCSG-6 and ABCSG-8 studies

Dubsky et al.: EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013; 24:640-647

Risk Assessment Independent From Ki67-Based Luminal A And B Classification

EndoPredict identifies high and low risk patients independent from Ki67-based luminal A and B classification. In validation studies, EndoPredict classified 29% of luminal A patients as high risk and 34% of luminal B patients as low risk.

Analysis of patients with ER+, HER2- breast cancer from both ABCSG-6 and ABCSG-8 studies

Dubsky et al.: EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013; 24:640-647