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Helping Guide Your Early-Stage Breast Cancer Treatment Decisions.

Invasive Breast Cancer

The Oncotype DX® test examines a patient's breast cancer tumor tissue at a molecular level, and gives information about the individual breast cancer diagnosis. This information can help tailor treatment for breast cancer. The Oncotype DX test is intended to be used for patients with early-stage (Stage I or II), node-negative, estrogen receptor-positive (ER+) invasive breast cancer who will be treated with hormone therapy.

The Oncotype DX test, developed by Genomic Health, determines how specific genes are expressed (that is, their level of activity) within a tumor sample. The measurement of these genes is calculated to yield an individualized result called a breast cancer Recurrence Score®. The Recurrence Score result correlates with the likelihood that a patient's breast cancer will return (distant recurrence) and also indicates whether he or she is likely to benefit from chemotherapy for breast cancer.

Traditionally, doctors have used breast cancer characteristics such as tumor size, tumor grade and lymph node status to estimate how likely breast cancer is to come back, and to help determine treatment decisions. These characteristics are still helpful in choosing a course of treatment, but the additional information provided by the Oncotype DX test can help physicians and patients determine the appropriate breast cancer treatment plan.

Oncotype DX has been included in the 2007 American Society of Clinical Oncology® (ASCO®) Clinical Guidelines on Use of Tumor Markers in Breast Cancer.i This inclusion represents a significant step forward for the role of molecular diagnostics in breast cancer treatment planning. Read more about the ASCO Clinical Guidelines on Use of Tumor Markers in Breast Cancer.

Oncotype DX has also been included in the National Comprehensive Cancer Network® (NCCN®) Breast Cancer Treatment Guidelines.ii Since 2008, this inclusion reinforces the significance of molecular diagnostics in breast cancer treatment planning and, in particular, the value of the individualized information provided by the Oncotype DX test. Learn more about the NCCN Guidelines for Patients.

Non-Invasive Breast Cancer / DCIS (Ductal Carcinoma In Situ)

The Oncotype DX Breast Cancer test for DCIS patients is the first clinically validated genomic assay to provide an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma) to help guide treatment decision-making in women with ductal carcinoma in situ treated by local excision, with or without tamoxifen.

The Oncotype DX Assay for DCIS Patients:

  • Is the first and only clinically-validated genomic assay for patients with DCIS.
  • Predicts the risk of local recurrence (DCIS or invasive carcinoma) and predicts the risk of local invasive carcinoma.
  • Helps guide personalized treatment based on tumor biology as determined by the DCIS Score.
  • Offers additional information: the report includes quantitative ER and PR single gene expression values.

Is The Oncotype DX Test Right For Me?

Oncotype DX is a genomic test that may help guide treatment decisions for patients with DCIS or early-stage ER+ breast cancer. However, the decision to use the Oncotype DX test as part of your breast cancer treatment plan is one that you and your doctor should discuss and make together.


iAmerican Society of Clinical Oncology and ASCO are registered trademarks of ASCO. ASCO does not endorse any product or therapy.
iiNational Comprehensive Cancer Network and NCCN are registered trademarks of NCCN. NCCN does not endorse any product or therapy. 

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Oncotype DX Resources

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