Oncotype DX

The Oncotype DX Breast Recurrence Score test is a genomic test that can be used in hormone receptor-positive, HER2-negative invasive breast cancer with zero to three positive lymph nodes. This test can help determine how likely a person is to benefit from treatment with chemotherapy, based on data from the TailorRx and RxPonder clinical trials. This test also:

• Provides information about the risk of breast cancer recurrence
• Estimates the likelihood of recurrence nine years from diagnosis, after completing treatment with five years of endocrine therapy alone

The Oncotype DX Breast Recurrence Score test is part of the standard treatment guidelines for the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO).

Another test, the Oncotype DX Breast DCIS Score, is designed for people diagnosed with ductal carcinoma in situ (DCIS), sometimes called stage 0 breast cancer. This test measures a person’s 10-year risk of the cancer returning within the breast duct or spreading outside of the duct and becoming invasive cancer.

These two tests are both performed on tumor tissue taken during a biopsy or surgery. A sample is sent to the Exact Sciences Lab in California for analysis. For early-stage, invasive breast cancer, the Recurrence Score can help your doctors decide whether chemotherapy is recommended, or whether it is reasonable to treat with endocrine therapy alone. For DCIS, the results help your doctors determine if you need radiation therapy.

Who is Oncotype DX for?

The Oncotype DX Breast Recurrence Score test can be used to test tumors from people of any age who have:

• Hormone receptor-positive, HER2-negative early-stage breast cancer
• Invasive breast cancer that is stage I, II, or IIIA (breast cancer in zero to three lymph nodes)

You may be eligible to get the Oncotype DX Breast DCIS Score test if you:

• Have been diagnosed with DCIS

While data are limited on how helpful genomic tests for early-stage breast cancer are in planning treatment for male breast cancer, some research suggests that the Oncotype DX Recurrence Score may provide information on the risk of recurrence for men as well.

How do Oncotype DX tests work?

The Oncotype DX Breast Recurrence Score test uses a tumor tissue sample to evaluate gene expression in 21 genes. It then scores the chances of recurrence within nine years and predicts whether you are likely to benefit from chemotherapy or can safely take endocrine therapy alone.

The Oncotype Breast DCIS Score test uses a tumor tissue sample to look at the activity of 12 genes. It scores the chances of a second DCIS diagnosis, or the development of invasive breast cancer, over the next 10 years.

What do Oncotype DX results mean?

When the lab analysis is complete, it generates a Recurrence Score of 0 – 100 that indicates your risk of recurrence. The higher the score, the more likely the risk of distant recurrence and the more likely it is that chemotherapy is beneficial for you. Specifically:

For women aged 50 years and younger with hormone receptor-positive, HER2-negative early-stage breast cancer with negative lymph nodes, based on data from the TailorRx trial, the following is typically recommended:

• Recurrence Score 0-15: You have a low risk for distant recurrence within 10 years if you take five years of endocrine therapy. There is likely no benefit to adding chemotherapy to your treatment plan.
• Recurrence Score 16-20: You have a slightly higher risk of distant recurrence within 10 years if you take five years of endocrine therapy. There is a low chance that adding chemotherapy to your treatment plan will help prevent the cancer from coming back, and your doctor may recommend it.
• Recurrence Score 21-25: You have a moderate risk of distant recurrence within 10 years if you take five years of endocrine therapy. Chemotherapy may be recommended as part of your treatment plan.
• Recurrence Score 26-100: You have a high risk of distant recurrence within 10 years if you take five years of endocrine therapy. You will benefit from chemotherapy as part of your treatment plan.

For women aged 50 years and younger with HR+/HER2- early-stage breast cancer with 1-3 positive lymph nodes, based on data from the RxPonder trial the following is typically recommended:

• Recurrence Score 0-100: The RxPonder trial demonstrated that pre-menopausal women benefitted from chemotherapy regardless of their Oncotype score. Therefore, based on this trial chemotherapy is often recommended. Sometimes, a physician may consider suppressing the ovaries and treating with an aromatase inhibitor instead of chemotherapy in select cases. Talk to your physician about which treatment is right for you.

For women aged 51 years and older with hormone receptor-positive, HER2-negative early-stage breast cancer with zero to three positive lymph nodes, based on data from the TailorRx and RxPonder trials, the following is typically recommended:

• Recurrence Score 0-25: You have a low risk for distant recurrence within 10 years if you take five years of endocrine therapy, and there is likely no benefit to adding chemotherapy to your treatment plan.
• Recurrence Score 26-100: You have a high risk for distant recurrence within 10 years if you take five years of endocrine therapy and chemotherapy is typically recommended.

For women diagnosed with hormone receptor-positive, HER2-negative DCIS, possible Recurrence Score results include:

• Recurrence Score 0-39: You have a low risk of DCIS coming back, and the benefit of radiation treatment is low.
• Recurrence Score 39-54: You have a moderate risk of DCIS coming back. Your doctor will use this information and other information about the tumor to determine whether you should get radiation therapy.
• Recurrence Score 54-100: You have a high risk of DCIS coming back and are likely to benefit from radiation therapy.

Paying for Oncotype DX

If you have private health insurance, your carrier may pay part or all of the cost of the Oncotype tests. It’s best to check your coverage before you have the test to avoid unexpected costs. Visit your insurance company’s online portal or call their customer service line to speak with someone about your plan’s coverage policy. Medicare and Medicaid may also provide some coverage of the cost of the Oncotype tests.

The maker of the Oncotype tests, Exact Sciences, offers a financial assistance program for people who meet certain eligibility requirements. The financial assistance page of their website has more information about how to qualify and a calculator to estimate what you’ll pay for the test based on your household income and family size.

For more information on financial assistance for breast cancer testing and treatment, visit our Financial Assistance page.