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Breast cancer recurrence test accurately predicts chemotherapy benefit

EndoPredict® Breast Cancer Prognostic Test is the most accurate predictive and prognostic early-stage breast cancer recurrence test, that provides accurate prediction of early and up to 15 years distant recurrence along with treatment benefit.1-4

Information for clinicians

Use EndoPredict for the most accurate predictive and prognostic assessment of breast cancer recurrence

EndoPredict is a second generation gene expression assay for pre- and postmenopausal women with ER positive, HER2 negative early-stage breast cancer that is lymph node positive or negative – and the only second generation test with level of evidence 1A data.5

As a second generation test, EndoPredict combines three factors – a molecular gene expression score, tumor size and nodal status – to give the EPclin Risk Score. The result is more prognostic power than first generation breast cancer recurrence tests that only measure gene expression.

The test has been developed and validated to include genes that predict both early and late metastasis. This focus on ER-related genes in addition to proliferative genes improves the unique prognostic power of EndoPredict compared with classical prognostic factors and first generation tests, like the Oncotype DX® test or MammaPrint®.

EndoPredict is also the only second generation test with a clear classification into low-risk and high-risk groups, and has a reliable cut-off value that has never changed.

How does EndoPredict compare to other tests?

EndoPredict vs Oncotype DX® and other commercially available tests.

EndoPredict's superior prognostic power

The TransATAC study compared the performance of four commercially available prognostic signatures for breast cancer distant recurrence, including first and second generation tests. The study included 774 patients treated with endocrine therapy alone for 5 years.1

Read clinical summary

The higher the C-index, the greater the prognostic power

The C-index is a statistical tool used to evaluate the accuracy of an algorithm and therefore the prognostic power of a test by comparing predicted outcomes with actual events. A high C-index indicates results cannot be chance (as in the flip of a coin which is chance and scores 0.5) but are due to the accuracy of the test. Results are independent of test cut-off values.

Confidently minimize the risk of under treatment for high-risk women

The EndoPredict test aligns more closely with observed risk.4

Study details (TransATAC concordance analysis):

  • n=117 (12.6%) were EPclin low-risk, but Oncotype DX® categorized these as non-low-risk
  • n=144 (15.5%) were EPclin high-risk, but Oncotype DX® categorized these as low-risk (even allowing for the revised cut‑off to ≤ 25). For these 144 EPclin high-risk patients, 10 year recurrence rate was 26.9%

Is it possible that 1 in 7 patients is under treated?

Read clinical summary

EndoPredict consistently identifies women with true low-risk of recurrence

Compared to risk stratification using only clinical parameters or other gene expression tests, EndoPredict identifies a large group of true low-risk breast cancer patients who could avoid chemotherapy.1,4,19 Learn more about this comparison study here.

In node positive patients, EndoPredict was one of the two signatures that identified patients with true low-risk of distant recurrence (<10%). Learn more about EndoPredict in node positive patients.

EndoPredict identifies a large group at low-risk of breast cancer recurrence

In all validation studies of ER positive, HER2 negative, node positive and node negative patients, EndoPredict identified a large low-risk group with a recurrence risk of less than 10%, regardless of whether the patients were pre- or postmenopausal.2-4,11,19-21

EndoPredict is the only second generation breast cancer recurrence test with level of evidence 1A data5

Initial results from a randomized controlled prospective phase III study (UNIRAD) released at SABCS 2021 prospectively confirm the validation studies.22

A prospective French registry (SiMoSein) including more than 4,700 patients emphasizes the clinical need for gene expression testing to avoid over and under treatment, as presented at ESMO 2021.23

Who is eligible for the EndoPredict test?

Premenopausal women

Studies show that regardless of nodal status, EndoPredict detects premenopausal patients who are at true low-risk that may safely avoid chemotherapy.22,24

Learn more

Nodal status

EndoPredict illuminates the right treatment pathway for every woman, regardless of nodal status or number of positive lymph nodes.

Learn more

EndoPredict second generation test can be performed locally within a few days

EndoPredict Breast Cancer Prognostic Test is available to order by clinicians via numerous local labs.

Order a test

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References

  1. 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
  2. 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
  3. 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
  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. 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
  6. Andre, Fabrice, et al. “Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update.” Journal of Clinical Oncology, vol 40, no. 16, 2022, pp. 1816-1837.
  7. Cardoso F, et al. “Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.” Annals of Oncology, vol 30, no. 8, 2019, pp. 1194-1220.
  8. Gradishar, William J et al. “NCCN Guidelines(R) Insights: Breast Cancer, Version 4.2021.” Journal of the National Comprehensive Cancer Network, vol 19, no. 5, 2021, pp. 484-493.
  9. National Institute of Health and Care Excellence. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. 2018.
  10. Giuliano, Armando E et al. “Breast Cancer-Major changes in the American Joint Committee on Cancer eighth edition cancer staging manual.” CA Cancer Journal for Clinicians, vol 67, no. 4, 2017, pp. 290-303.
  11. 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
  12. Qi, Peng et al. “Concordance of the 21-gene assay between core needle biopsy and resection specimens in early breast cancer patients.” Breast Cancer Research and Treatment, vol 186, no. 2, 2021, pp. 327-342.
  13. Genomic Health. Node-negative physician to patient brochure: Helping with your breast cancer treatment decisions. 2019.
  14. Genomic Health. Node-positive physican to patient brochure: Helping with your breast cancer treatment decisions. 2019.
  15. Agendia. “Breast Cancer Suite: Physicians-Brochure.” 2015, Available: https://www.agendia.com/media/M-ROW-010-V2_Breast-Cancer-Suite-Physicians-Brochure.pdf
  16. Kleijn M, et al. “Comparing MammaPrint and BluePrint results between core needle biopsy and surgical resection breast cancer specimens.” 17th St Gallen International Breast Cancer Conference 2021, pp. 111.
  17. Agendia. “MammaPrint, Sample report.” 2013, Available: https://www.agendia.com/wp-content/uploads/2013/05/AGE594_US_Mamma_Under61_lowV2_UPDATED.pdf
  18. Veracyte. “Package Insert: Prosigna® Breast Cancer Prognostic Gene Signature Assay.” 2022, Available: https://everythinggeneticltd.co.uk/wp-content/uploads/2023/02/ProsignaDx-Package-Insert_English-for-EU_2022-05-LB-0032-01_D1.pdf
  19. 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
  20. 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
  21. Constantinidou, Anastasia et al. “Clinical Validation Of Endopredict In Premenopausal Women With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer.“. Journal Of Clinical Oncology, vol 39, no. 15_suppl, 2021, pp. 537-537
  22. 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
  23. 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
  24. 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