Prospective Phase III validation for EndoPredict – Read more

Node negative breast cancer recurrence

EndoPredict® Breast Cancer Prognostic Test identifies more patients with node negative disease at true low-risk of breast cancer recurrence than any other test.

Information for clinicians

Who needs chemotherapy for node negative breast cancer?

The recurrence rate in women with ER positive/HER2 negative early-stage node negative breast cancer is generally low and many patients do not need adjuvant chemotherapy. However, Myriad Genetics believes every patient matters and deserves to know their true risk of breast cancer recurrence to help guide shared treatment decision-making.

EndoPredict identifies the largest low-risk group of node negative women that can avoid chemotherapy, while accurately recognizing high-risk patients that will benefit from chemotherapy.1-5

It is the only second generation breast cancer prognostic test validated for premenopausal AND postmenopausal women with early-stage breast cancer that is ER positive, HER2 negative, node negative or positive1-7 – and the first second generation test with level of evidence 1A data.8,9

If you are a patient, please ask your doctor if the EndoPredict test is right for you, or visit our patient homepage for more information.

EndoPredict is validated in thousands of node negative patients to identify
a large low-risk group

Study details

  • Analyzed from the prospective-retrospective validation in the independent, large ABCSG6, ABCSG82 and TransATAC3 randomized prospective phase III trials
  • 1,845 node negative women with ER positive/HER2 negative primary breast cancer
  • Patients received 5 years of endocrine therapy only

Study results

  • 73-78% of patients were identified as low-risk, with a 10-year outcome of only 5-6% distant recurrence events if treated with endocrine therapy only
  • 22-27% were categorized as high-risk with a significant higher risk of distant recurrence if treated with endocrine therapy only

EndoPredict successfully identifies the majority of node negative patients that can avoid chemotherapy BUT also recognizes women who do need it

EndoPredict identifies more true low-risk patients than other first or second generation tests

In the TransATAC head-to-head comparison, EndoPredict identifies the largest group at true low-risk of recurrence in patients with node negative breast cancer, with a recurrence risk of less than 10%.3,10 It’s also significantly more accurate than first generation tests like the Oncotype DX® test.1,10

Learn more about EndoPredict’s superior accuracy versus first generation tests.

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.

EndoPredict is validated in premenopausal women with node negative disease

EndoPredict is the only second generation test validated for both node positive and node negative breast cancer recurrence in premenopausal women with ER positive/HER2 negative early-stage breast cancer.6

A recent study of premenopausal patients demonstrated that EPclin Risk Score is strongly associated with 10-year distant recurrence free survival – regardless of nodal status.6

For node negative disease, this was shown in a subset analysis of 323 women from this study, after a median follow-up of 9.7 years.6

Guidelines recommend EndoPredict

EGTM (2017)

“In combination with established clinical and pathological factors, EndoPredict may be used for predicting outcome and aiding adjuvant therapy decision-making in [ER positive] HER2-negative patients that are either lymph node negative or lymph node positive…”11

ESMO (2019)

“[EndoPredict] may be used to gain additional prognostic and/or predictive information to complement pathologic evaluation and to predict chemotherapy benefit for N0 and N+ (1-3 positive lymph nodes) disease in uncertain cases.12

Level of evidence 1B

ASCO (2022)

Recommended for postmenopausal women with N0/N+ (1-3 nodes) to guide adjuvant endocrine and chemotherapy decisions.13

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 in your country or outside of the EU also via Myriad Genetics’ central laboratory in Salt Lake City, USA.

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. 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
  4. 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
  5. 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
  6. 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
  7. 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
  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. 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
  11. Duffy, M.J. et al. “Clinical Use Of Biomarkers In Breast Cancer: Updated Guidelines From The European Group On Tumor Markers (EGTM)“. European Journal Of Cancer, vol 75, 2017, pp. 284-298
  12. 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
  13. 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