How Risk Status Can Affect Breast Cancer Treatment Decisions

Among patients with breast cancer, knowledge of their tumor’s genomic risk status (ultra-low, low or high) can inform treatment decisions, an expert explained in an interview with CURE.

“Low risk, which includes both low and ultra-low, are cancers that we don't think have a very high chance of coming back, at least not in the next five years or so. That type of cancer doesn't appear to need chemotherapy at all, but it does need anti-estrogen therapy. High-risk cancers seem to have a higher chance of coming back earlier, which means that chemotherapy is an important first treatment for that kind of cancer,” explained Dr. William Audeh, chief medical officer of Agendia, Inc.

Agendia is the company behind the MammaPrint 70-gene profiling test. The company recently announced findings from the ongoing FLEX study, published in JNCI Cancer Spectrum, which the company said demonstrate the test’s predictive utility for chemotherapy benefit for patients with hormone receptor-positive, HER2-negarive early-stage breast cancer.

Audeh spoke with CURE about why this information is valuable for patients and their care teams.

Transcript

Can you explain what it means for a tumor to be classified as at low, ultra-low or high genomic risk, and how this impacts treatment decisions?

I think tests like MammaPrint are valuable because they look at the genes that are driving the cancer and making it behave the way it does. This is extra, helpful information that we can't get any other way, as it's not available from looking at the cancer under a microscope. The MammaPrint test looks at 70 genes that are either overactive or underactive to predict how the cancer might behave.

Low-risk cancers, which include both low and ultra-low, are those that we don't think have a very high chance of coming back, at least not in the next five years or so. This type of cancer doesn't appear to need chemotherapy at all, but it does need anti-estrogen therapy. High-risk cancers seem to have a higher chance of coming back earlier, which means that chemotherapy is an important initial treatment for that kind of cancer.

Within the low-risk category, we have two subcategories: ultra-low and low. Ultra-low is unique. We've found that, at least for women who are past menopause, an ultra-low result identifies a type of breast cancer with such a good outcome that they may not even need the full five years of anti-estrogen medication, which is the standard duration of treatment. If you are ultra-low and experiencing side effects from those medications, it appears safe to stop earlier than five years.

Transcript has been edited for clarity and conciseness.

Reference

1. “Agendia Announces Publication in JNCI Cancer Spectrum Demonstrating that MammaPrint® Predicts Chemotherapy Benefit in HR+HER2- Early Breast Cancer Using Real-World Evidence from the FLEX ,” by Agendia. News release; Aug. 12, 2025.

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