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About the Oncotype DX breast cancer test

ONCOTYPE DX BREAST RECURRENCE SCORE

About the Oncotype DX Breast Recurrence Score Test

From the moment breast cancer is diagnosed, your patient depends on you to recommend the best course of action. But, it is important to remember that no two breast cancer patients—or their tumors—are alike.

The Oncotype DX Breast Recurrence Score test provides a genomic-based, comprehensive, individualized risk assessment for early-stage invasive breast cancer in adjuvant and neoadjuvant settings. The test provides valuable information you can use to personalize a treatment plan specifically for each patient’s situation—including risk of distant recurrence, the benefit from chemotherapy and whether your patient can be treated effectively with hormonal therapy alone.1-6

INCORPORATED IN ASCO®, NCCN®, AND ESMO GUIDELINES, ST. GALLEN CONSENSUS, AND NICE DIAGNOSTIC GUIDANCE*
Included in all major breast cancer treatment guidelines

The Breast Recurrence Score test is recognized as the standard of care. It’s included in clinical guidelines from organizations such as the American Society of Clinical Oncology (ASCO®), the National Comprehensive Cancer Network (NCCN®), the St. Gallen Consensus panel, the National Institute for Health Care Excellence (NICE), the European Society for Medical Oncology (ESMO) and the German Association of Gynecological Oncology (AGO).7-12*

How it works

The Breast Recurrence Score test is proven to predict the likely benefit of chemotherapy2, 3—as well as the risk of distant recurrence1, 4—for patients who are newly diagnosed with early-stage invasive breast cancer. Eligible patients are diagnosed with early stage, ER+, HER2- breast cancer with either node-negative or node-positive disease. The test uses RT-PCR to measure the expression of 21 genes: 16 cancer-related genes and five reference genes – in a tumor sample after it has been removed by surgery or biopsy.

EARLY STAGE

ER (+)

HER2 (-)

NODE (-)

NODE (+)

THE ONCOTYPE DX BREAST RECURRENCE SCORE: PREDICTIVE AND PROGNOSTIC RESULTS YOU CAN COUNT ON

By testing every eligible patient after surgery, but before you discuss her treatment plan, you can make recommendations with increased insight and confidence.

The Breast Recurrence Score report: Informative for both clinicians and patients

The results are presented as a quantitative score, based on a continuous scale from 0-100. The score reflects individual tumor biology—the higher the score, the higher the risk of distant recurrence and the higher the likelihood of chemotherapy benefit are for that patient.2 The Breast Recurrence Score result can serve as a reference point for all members of the treatment team and can make discussing treatment options with your patients easier and more efficient.

The Breast Recurrence Score report also provides a quantitative ER score by RT-PCR to help assess the magnitude of hormonal therapy benefit13 and other supporting information (such as PR and HER2 scores). The test can provide insight into specific tumor biology, risk assessment and can inform treatment options.

Learn more about the results and see sample reports.

Excellent patient outcomes

Several large, independently run, international studies—including more than 63,000 patients15-23—found that the Breast Recurrence Score test is accurately associated with patient outcomes, including risk of distant recurrence and breast cancer survival. In addition, studies show that approximately 99% of node-negative patients with low Breast Recurrence Score results who were primarily treated using hormonal therapy alone (without chemotherapy) were distant recurrence-free after five years.14, 18 Get more details about these and other clinical studies regarding the Breast Recurrence Score test.

Node-negative and node-positive cancer

Whether patients have node-negative or node-positive breast cancer, the Breast Recurrence Score test is both prognostic and predictive – providing both important prognostic information about the estimated risk of distant recurrence and the likelihood of adjuvant chemotherapy benefit.1-6

Learn more about the study results:

Node-Negative Prognostic Clinical Trial Results
Node-Negative Predictive Clinical Trial Results
Node-Positive Prognostic Clinical Trial Results
Node-Positive Predictive Clinical Trial Results
Neoadjuvant therapy

For patients with large tumor to breast ratios who are interested in breast-conserving surgery, neoadjuvant therapy—such as chemotherapy or endocrine therapy—is an increasingly common consideration.

Research results have shown that the Breast Recurrence Score test is a predictor of response to neoadjuvant treatment and provides useful information to guide systemic treatment decisions:22-26

  • Neoadjuvant studies are consistent with adjuvant studies that the Recurrence Score results correlate with benefits from adjuvant hormonal therapy and chemotherapy.
  • Results indicate that lower Recurrence Score results are associated with greater clinical responses from neoadjuvant hormonal therapy.
  • Findings suggest that higher Recurrence Score results are associated with greater clinical and pathologic responses from neoadjuvant chemotherapy.

Download a detailed summary of research results

Locoregional recurrence risk

A significant association was observed in studies between Breast Recurrence Score results and the risk for locoregional recurrence (LRR), in both node-negative and node-positive patients.27, 28 The results of these studies have potential clinical implications for locoregional therapy decisions for patients with node-negative or node-positive ER-positive breast cancer.

  • The Recurrence Score result in node-negative patients was an independent, significant predictor of LRR along with age and type of initial treatment.
  • In the node-positive setting, the Recurrence Score result is an independent predictor of LRR along with number of positive nodes and tumor size. These findings may have clinical implications regarding patient selection for post-mastectomy chest wall and regional nodal radiation therapy (XRT) and post-lumpectomy regional nodal XRT in node-positive, ER-positive patients treated with adjuvant chemo-endocrine therapy.
Late recurrence risk

ASCO® guidelines recommend 10 years of hormonal therapy for ER-positive breast cancer based on the aTTom and ATLAS studies.29, 31 The challenge facing physicians is identifying which patients are at higher risk of distant recurrence after five years of hormone therapy.

The Breast Recurrence Score test may identify patients who are at higher risk of distant recurrence beyond five years and might have greater benefit from extended hormonal therapy.32

  • The association between quantitative ER and tamoxifen benefit has been shown in the landmark NSABP B-14 study.13
  • The Recurrence Score result was significantly associated with prediction of late distant recurrence (years 5-15) in patients with higher quantitative ER expression (> 9.1).32

See the full study reportď‚Ž

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