What is EndoPredict?

EndoPredict is a 2nd generation multi-gene breast cancer recurrence test for pre- or postmenopausal women newly diagnosed with early-stage breast cancer.  Created for the purpose of highly accurate assessment of 5 to 15-year risk of distant recurrence of the disease EndoPredict combines into an unique indicator (EPClin score) gene expression with clinically pathological features providing outstanding prognostic performance that will ensure the healthcare professional that chemotherapy is or is not required to accompany endocrine treatment.

EndoPredict has demonstrated superiority versus other similar tests in a recently published retrospective bio-marker analysis that included 774 postmenopausal women with ER+, HER2– breast cancer, pooled data being obtained within January 2009 until April 2015*.

*Source: Sestak I. et al. Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor-Positive Breast Cancer. A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncology Published online February 15, 2018. Read more about it here: https://jamanetwork.com/journals/jamaoncology/fullarticle/2672388

Who should take the test?

is appropriate for women with:

early-stage invasive breast cancer (ref Filipits)
ER+, HER2− receptor status (ref Filipits)
node-negative (N0) and node-positive (N1) (1-3 nodes)

What are the Clinical Benefits of the test?

EndoPredict test is used to help make specific therapy choices based on the cancer’s risk of coming back in a part of the body away from the breast within a timeframe of 15 years after initial diagnosis. It provides a prognostic result formulated as either “low-risk” or “high-risk” of breast cancer recurring as distant metastasis.

Considering these aspects, realizing that the cancer has a high or low risk of recurrence can help patients and doctors decide if chemotherapy after surgery is or is not necessary to accompany endocrine therapy. Essentially, the test identifies a large population of really low-risk* patients with excellent 10-year outcomes with 5 years of endocrine therapy alone (<10% chance of distant recurrence).

What DNA sample is required to perform the test?

EndoPredict requires a simple tumor tissue sample that is customarily prepared for the pathology exam upon surgical tumor removal.

An eligible tumor sample for EndoPredict should have been obtained prior to the administration of any systemic endocrine therapy and/or chemotherapy.

Frequently Asked Questions

Why do I need genetic testing if I have ER+ & HER2- breast cancer?

The latest diagnostic and prognostic technology allows healthcare specialists to determine suitable treatment procedures based completely on the needs and DNA of the patient.

Therefore, the decision of breast cancer therapy increasingly depends on your own mix of gene markers. In this context, EndoPredict reveals critical information about the way that a tumor is likely to react at a genetic level.

Why is EndoPredict relevant?

EndoPredict’s ability to forecast the probability of early and late metastases with greater precision than any other available test on the market allows chemotherapy to be addressed only to those patients who will receive the maximum clinical benefit from it. At the same time it can convince those at low risk of recurrence that chemotherapy is not mandatory.

In these cases, they will be sufficiently treated, for example, with a five-year systemic endocrine therapy that doesn’t require a complex treatment scheme.

Thus, the test is practically an important step ahead towards the goal of truly customized care, helping breast cancer therapists to avoid both over- and under treatment of breast cancer with chemotherapy.

When do breast cancer metastases occur?

Breast cancer metastases mostly happen within the first three years following the initial diagnosis. Nonetheless, breast cancer tumors positive for hormone receptors (HR+) and negative for HER2 generally metastasize at a much slower rate.

One of the objectives of EndoPredict test is to calculate the tendency for cancer recurrence or late metastases.

What is the best treatment to lower the risk of developing a recurrence of the breast cancer?

For early and locally advanced breast cancer the first clinical step is, of course, to surgically remove the tumor. The next step requires a more complex decision.

Regarding the majority of patients who are in the Her2-/ER+ group, the doctors have to consider the risk/benefit profile when examining an “endocrine only” in contrast to an “endocrine + chemotherapy” treatment scheme to reduce the risk of developing distant metastases.
Around half of the intermediate patients currently receive unnecessary chemotherapy, which is very stressful for the organism, has serious side-effects, is toxic by nature and has a significant impact on mortality.

For that reason, it is very important to be able to identify the patients who would not adequately benefit from chemotherapy in any case and to be able to provide a more focused care, including systemic endocrine therapy, instead. EndoPredict manages to make this happen.

The result? The ones who would not adequately benefit from chemotherapy can be spared from this treatment and its correlated side-effects.

How does the test work?

Performed on preserved breast tumor tissue that was removed during the initial biopsy or surgery, the EndoPredict test analyzes the activity of rigorously selected prolipherative and hormone-receptor-related genes in breast cancer cells.

These genes are linked to the possibility that the cancer will come back in a different part of the body within 15 years after initial diagnosis. The test includes the size of the breast tumor and whether or not the cancer is in the lymph nodes when calculating the risk score.

The results are given as an EPclin Risk Score shown on a curve to clarify an individual’s personal risk of recurrence – a number between 1.1 and 6.2 that outlines a percentage risk of relapse. The scores are recognized either low-risk or high-risk:

an EPclin Risk Score higher than 3.3287 (higher than a 10% risk of recurrence) – a high risk of recurrence

an EPclin Risk score lower than 3.3287 (lower than a 10% risk of recurrence) – a low risk of recurrence

Of course, the EPclin Risk Score includes other factors, such as the grade of the cancer, the number of hormone receptors the cancer cells have (many versus few), and the patient’s age.

The therapy decisions endorsed by EndoPredict offer a high level of diagnostic confidence;

EndoPredict was shown to accurately predict cancer-specific disease progression and metastasis in multiple clinical outcome studies with more than 3,000 patients;

Chemo-sparing benefit observed in more than 70% of node-negative breast cancer patients;

Chemo-sparing benefit observed in up to one-third of node-positive breast cancer patients.

Subscribe for a test

If you or someone you know might be interested in benefiting of EndoPredict’s science to help you choose the best treatment option for breast cancer, subscribe here and one of our experts will setup a planning for you to gain access to this genetic test. Tell us more about your interest and inquiries by filling in the next contact form and we’ll be in touch shortly.

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The testing process may be complex and it’s essential to have a trusted resource when making decisions. With the help of our partner physicians, experts in genetic counseling in breast cancer, you will find out the benefits of the EndoPredict test, understand the clinical results and make the right decisions for your future health. Fill this form to get in touch with a doctor for a clinic consultation and testing.

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