Node positive breast cancer and chemotherapy

EndoPredict^® Breast Cancer Prognostic Test is the only second generation gene expression test with level of evidence 1A data.^1,2 The test is extensively validated in node negative and node positive disease, allowing more women to safely avoid adjuvant chemotherapy.

Information for clinicians

Do all node positive patients need chemotherapy?

In lymph node positive breast cancer treatment, the challenge is to avoid over treatment and the life-changing impact this can have on a woman’s life, without increasing the risk of node positive breast cancer recurrence.

EndoPredict is an accurate prognostic test for women with breast cancer regardless of lymph node status, reliably guiding lymph node positive breast cancer treatment.

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 positive^3-8 – and the first second generation test with level of evidence 1A data.^1,2

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 has level of evidence 1A data in node positive breast cancer

Data presented at SABCS 2021 from a prospective randomized phase III study confirms the accuracy and prognostic power of EndoPredict.¹

In the analysis of 767 pre- or postmenopausal node positive, clinically high-risk, chemotherapy-treated patients, there was significant dichotomization between high-risk and low-risk groups. The EPclin low-risk group experienced no invasive disease events with a median follow-up of 55 months.

This study represents the first prospective validation in a randomized controlled trial of a second generation breast cancer test, allowing confident decisions when deciding lymph node positive breast cancer treatment.

EndoPredict outperforms first generation Oncotype DX^® in node positive early-stage breast cancer ^6,10

In node positive subgroups of breast cancer patients, EndoPredict outperforms the first generation Oncotype DX^® test and more accurately identifies the true low-risk patients.¹⁰ In a direct head-to-head comparison, the EndoPredict low-risk group remains low, within the 10-year risk of <10% distant recurrence specified by guidelines.

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Study results:

Both tests show good performance for early metastases. The risk in the Oncotype DX^® low-risk group at 5 years is comparable to the 5-year risk observed prospectively in RxPonder¹¹
In this study, 24% of node positive patients were classified as EPclin low-risk with a recurrence rate of 5.6%
Oncotype DX^® performs well at 5 years, but shows a high proportion of late recurrence in the low-risk group (14.4% recurrences between year 5 and 10, even with the old, lower cut-off of 18)

57% of patients were categorized as RS low-risk, with a 10-year distant recurrence rate of 19% — outweighing the guideline-based 10% cut-off for chemotherapy indication.

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.

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References

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
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
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
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
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
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
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
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
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
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
Kalinsky, Kevin et al. “21-Gene Assay To Inform Chemotherapy Benefit In Node-Positive Breast Cancer”. New England Journal Of Medicine, vol 385, no. 25, 2021, pp. 2336-2347