EndoPredict® evidence hub

EndoPredict Breast Cancer Prognostic Test has clinical evidence across thousands of patients, the most of any second generation gene expression test for breast cancer recurrence.

Summary of evidence

EndoPredict has a depth of clinical evidence in patients with ER positive/HER2 negative early-stage breast cancer, established in over 3,500 patients, across 5 validation trials, and with up to 15 years of clinical data in some women.1-7

EndoPredict is validated across node positive and node negative patients, as well as both premenopausal and postmenopausal women – the only second generation breast cancer recurrence gene expression test to do so.

This second generation test is recommended by many international and national guidelines to help clinicians and their patients make confident chemotherapy treatment decisions together, and provide information about need for long-term endocrine therapy.

Clinical validation of EndoPredict

EndoPredict is independently validated for robust prognostic results.1-4

  • Training: the algorithm for the EPclin Risk Score was generated using a large training set of 964 ER positive/HER2 negative breast cancer tumor samples. These included pre- and postmenopausal patients with node negative or node positive disease
  • Validation: Unlike other tests, validation of EndoPredict used pre-specified risk scores and one consistent cut-off value across five independent prospective-retrospective studies with more than 3,500 patients included in randomized prospective phase III clinical trials. Learn more about EndoPredict clinical trials here.
  • Results: EndoPredict consistently identified a large low-risk group with a 10-year recurrence risk of less than 10%. Regardless of whether the patients were pre- or postmenopausal, node negative or positive

Recurrence risk data up to 15 years

EndoPredict is the only test providing breast cancer recurrence risk up to 15 years.2

Learn more about how EndoPredict provides a 15-year recurrence risk

Level of evidence 1A8 prospective data for EndoPredict

EndoPredict has the first prospective validation of prognostic risk classification for a second generation gene expression test in a randomized trial of node positive, clinically high-risk, chemotherapy-treated patients.9

Decision impact studies

EndoPredict impacts therapeutic decision-making, reflected in the published decision impact studies in this table, which enrolled over 1,000 patients across five different countries.9-14

Learn more about EndoPredict publications below.

More prospective data

A prospective French registry (SiMoSein) with more than 4,700 patients presented at ESMO 2021 emphasizes the clinical need for gene expression testing to avoid over and under treatment.15

This data illustrates that gene expression assays such as EndoPredict are the cornerstone for assessment of prognosis in patients with early ER positive, HER2 negative breast cancer. With 4,766 patients from 14 laboratories, the French national registry SiMoSein is the largest registry worldwide for patients tested with EndoPredict in a real-world setting.

Other prospective data are also expected soon for EndoPredict in the ongoing RESCUE study. Find out more on our clinical trials page.

Clinical performance of EndoPredict

You can find all of these studies on our publications page, where you can find a full list of published materials to support EndoPredict.

Node positive disease

  • EndoPredict is the only second generation test with level of evidence 1A data in clinically high-risk, chemotherapy-treated patients9
  • In node positive subgroups EndoPredict outperforms the first generation test Oncotype DX® and more accurately predicts the true low-risk patients16

Node negative disease

  • EndoPredict identifies the largest group of true low-risk patients compared to other tests16
  • EndoPredict’s prognostic and predictive value is independent of nodal status, and still identifies high-risk node negative patients that can avoid under treatment3,5

Premenopausal patients

  • EndoPredict is the only second generation test validated for premenopausal patients5
  • EndoPredict detects a large group of true low-risk premenopausal patients, regardless of nodal status5
  • EndoPredict is the only second generation test with prospective proof that it can identify low-risk premenopausal patients17

Choose EndoPredict for fast, easy, accurate results for every patient

References

  1. Filipits, Martin et al. “A New Molecular Predictor Of Distant Recurrence In ER-Positive, HER2-Negative Breast Cancer Adds Independent Information To Conventional Clinical Risk Factors“. Clinical Cancer Research, vol 17, no. 18, 2011, pp. 6012-6020
  2. Filipits, Martin 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“. Clinical Cancer Research, vol 25, no. 13, 2019, pp. 3865-3872
  3. Sestak, Ivana et al. “Prediction Of Chemotherapy Benefit By Endopredict In Patients With Breast Cancer Who Received Adjuvant Endocrine Therapy Plus Chemotherapy Or Endocrine Therapy Alone“. Breast Cancer Research And Treatment, vol 176, no. 2, 2019, pp. 377-386
  4. Buus, Richard et al. “Comparison Of Endopredict And Epclin With Oncotype DX Recurrence Score For Prediction Of Risk Of Distant Recurrence After Endocrine Therapy“. Journal Of The National Cancer Institute, vol 108, no. 11, 2016, p. djw149
  5. Constantinidou, Anastasia, et al. “Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer”. Clinical Cancer Research, vol. 28, no. 20, 2022, pp. 4435–4443
  6. Martin, Miguel et al. “Clinical Validation Of The Endopredict Test In Node-Positive, Chemotherapy-Treated ER+/HER2− Breast Cancer Patients: Results From The GEICAM 9906 Trial“. Breast Cancer Research, vol 16, no. 2, 2014, p. R38
  7. Dubsky, Peter et al. “The Endopredict Score Provides Prognostic Information On Late Distant Metastases In ER+/HER2− Breast Cancer Patients“. British Journal Of Cancer, vol 109, no. 12, 2013, pp. 2959-2964
  8. Simon, Richard et al. “Use Of Archived Specimens In Evaluation Of Prognostic And Predictive Biomarkers”. Journal Of The National Cancer Institute, vol 101, no. 21, 2009, pp. 1446-1452
  9. Penault-Llorca, Frederique et al. “Prognostic value of EndoPredict test in patients screened for UNIRAD, a UCBG randomized, double blind, phase III international trial evaluating the addition of *** (EVE) to adjuvant hormone therapy (HT) in women with high risk HR+, HER2- early breast cancer (eBC)“. SABCS 2021, PD-09-08 Spotlight Poster Discussion 9
  10. Müller, Berit Maria et al. “The Endopredict Gene-Expression Assay In Clinical Practice – Performance And Impact On Clinical Decisions“. Plos ONE, vol 8, no. 6, 2013, p. e68252
  11. Ettl, Johannes et al. “Decision Impact And Feasibility Of Different ASCO-Recommended Biomarkers In Early Breast Cancer: Prospective Comparison Of Molecular Marker Endopredict And Protein Marker Upa/PAI-1“. PLOS ONE, vol 12, no. 9, 2017, p. e0183917
  12. Fallowfield, Lesley et al. “Enhancing Decision-Making About Adjuvant Chemotherapy In Early Breast Cancer Following Endopredict Testing“. Psycho-Oncology, vol 27, no. 4, 2018, pp. 1264-1269
  13. Villarreal-Garza, Cynthia et al. “Change In Therapeutic Management After The Endopredict Assay In A Prospective Decision Impact Study Of Mexican Premenopausal Breast Cancer Patients“. PLOS ONE, vol 15, no. 3, 2020, p. e0228884
  14. Dinh, Phuong et al. “Impact Of The Endopredict Genomic Assay On Treatment Decisions For Oestrogen Receptor-Positive Early Breast Cancer Patients: Benefits Of Physician Selective Testing“. Breast Cancer Research And Treatment, vol 191, no. 3, 2021, pp. 501-511
  15. Lehmann-Che, Jacqueline et al. “Simosein, A Real-Life Prospective Evaluation Of Endopredict Use In Early ER-Positive, HER2-Negative Breast Cancers“. Annals Of Oncology, vol 32, 2021, p. 430
  16. Sestak, Ivana et al. “Comparison Of The Performance Of 6 Prognostic Signatures For Estrogen Receptor–Positive Breast Cancer“. JAMA Oncology, vol 4, no. 4, 2018, pp. 545-553
  17. Vázquez-Juarez, Daniela et al. ”Follow-up of prospective cohort of Mexican premenopausal women with breast cancer who received guided adjuvant treatment with the EndoPredict assay.” SABCS 2021, P4-05-15