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.

TAILORx: The largest, independently-led, randomized adjuvant breast cancer treatment trial

The landmark TAILORx trial enrolled 10,273 patients from over 1,000 sites who were candidates for adjuvant chemotherapy as per NCCN Guidelines and monitored their 9-year outcomes. The trial investigated the clinical utility of Oncotype DX Breast Recurrence Score test to confidently predict the patient population who will substantially benefit from chemotherapy. Patients with Recurrence Score (RS) results 0-25 showed excellent outcomes when treated with endocrine therapy alone, while patients with RS results 26-100 are known to have significant chemotherapy benefit.2 TAILORx also showed that standard clinical risk features alone are not sufficient to determine chemotherapy benefit - often leading to overtreatment or undertreatment of patients. Only the Oncotype DX Breast Recurrence Score test provides clarity for adjuvant treatment decisions.

TAILORx results eliminated intermediate scores and showed that most patients do not benefit from chemotherapy


Breast Recurrence Score Result Bar


TAILORx showed that clinical risk features alone are not sufficient to determine chemotherapy benefit

25% of patients with a low Recurrence Score (RS) result (0–25) had high clinical risk* and would have been overtreated without the RS result

*High clinical risk: Grade 1, > 3 cm; Grade 2, > 2 cm; Grade 3, > 1 cm.
43% of patients with a high Recurrence Score (RS) result (26–100) had low clinical risk** and would have been undertreated without the RS result

**Low clinical risk: Grade 1, ≤ 3 cm; Grade 2, ≤ 2 cm; Grade 3, ≤ 1 cm.

TAILORx trial demonstrated the precision with which the Oncotype DX Breast Recurrence Score test allows us to predict with confidence the patients who will benefit from chemotherapy and who will not. Knowing the Oncotype DX Breast Recurrence Score can guide you and your patient to the right systemic adjuvant treatment decision.

Learn more about TAILORx

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

The Recurrence Score result is directly associated with the rate of distant recurrence.1, 4

NSABP B-14 Study

10-year rate of distant recurrence was significantly lower for patients with low Recurrence Score results compared to high results

NSABP B-14: Prospective analysis of archived tissue from 668 stage I or II patients with estrogen receptor (ER)–positive, node-negative, invasive breast cancer treated with tamoxifen. Twenty-nine percent of patients were < 50 years of age, and 62% had tumors that were ≤ 2.0 cm in size. The majority of patients (51%) in this study had low Recurrence Score results.1

 
Node-Negative Predictive Clinical Trial Results

Only the Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-negative patients.2

NSABP B-20 Study

Low Recurrence Score result predicted little to no benefit from chemotherapy

NSABP B-20 Study

High Recurrence Score result predicted large benefit from chemotherapy

NSABP B-20: Prospective analysis of archived tissue from 651 patients with ER-positive, node-negative, invasive breast cancer treated with tamoxifen or tamoxifen plus CMF/MF. Approximately 45% of the patients were < 50 years of age, two-thirds of tumors were ≤ 2.0 cm in size, and 16% of tumors were progesterone receptor-negative.2

 
Node-Positive Prognostic Clinical Trial Results

The Oncotype DX Breast Recurrence Score test provides important prognostic information about the estimated risk of distant recurrence for node-positive patients.4

TransATAC Study

Rate of distant recurrence increases with the number of positive nodes for all the Recurrence Score values

The 9-year risk of distant recurrence increased with the number of positive nodes and the Recurrence Score result.

TransATAC: Prospective analysis of archived tissue from 1,231 post-menopausal patients with invasive breast cancer treated with tamoxifen or an aromatase inhibitor, of whom 1,178 were estrogen receptor-positive and either node-negative or node-positive. Of 306 node-positive patients, 79% had 1-3 positive nodes, 21% had ≥ 4 positive nodes, and 4% had unknown nodal status. The mean age was 64 years, and 67% of tumors were ≤ 2.0 cm in size. 4

 
Node-Positive Predictive Clinical Trial Results

Only the Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-positive patients.3

SWOG 8814 Study

Low Recurrence Score results predicted little to no benefit from chemotherapy

SWOG 8814 Study

High Recurrence Score results predicted large benefit from chemotherapy

SWOG 8814: Prospective analysis of archived tissue from 367 post-menopausal, hormone receptor-positive, node-positive patients with invasive breast cancer treated with tamoxifen or tamoxifen plus cyclophosphamide/doxorubicin/fluorouracil (CAF). Approximately 62% had 1-3 positive nodes and the remainder had ≥4 positive nodes. Mean age was 60 years (range 42–81), 21% were progesterone receptor (PR)–negative, and 63% of tumors were 2 cm to 5 cm in size.3

 

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 detailed 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 report

MORE TOPICS:

  • Clinical validation trials
  • Comparison to other genomic tests
  • Patient eligibility criteria
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    5. Habel et al. Breast Cancer Res. 2006.
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    7. Harris et al. J Clin Oncol. 2016.
    8. NCCN Clinical Practice Guidelines in Oncology. V.2.2017.
    9. NICE Diagnostics Guidance 10. 2013.
    10. Senkus et al. Ann Oncol. 2015.
    11. Coates et al. Ann Oncol. 2015.
    12. www.ago-online.de Guidelines Breast Cancer.
    13. Kim et al. J Clin Oncol. 2011.
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    15. Petkov et al. npg Breast Cancer. 2016.
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    18. Stemmer et al. SABCS 2015.
    19. Stemmer et al. ESMO 2016.
    20. Roberts et al. Breast Cancer Res Treat. 2017.
    21. Shak et al. ESMO 2016.
    22. Gianni et al. J Clin Oncol. 2005.
    23. Ueno et al. Int J Clin Oncol. 2013.
    24. Yardley et al. Breast Cancer Res Treat. 2015.
    25. Bear et al. SABCS 2016.
    26. Robidoux et al. Miami Breast Cancer Conference 2017.
    27. Mamounas et al. J Clin Oncol. 2010.
    28. Mamounas et al. J Natl Cancer Inst. 2017.
    29. Burstein et al. J Clin Oncol. 2014.
    30. Davies et al. Lancet. 2013.
    31. Al-Mubarak et al. PLoS One. 2014.
    32. Wolmark et al. J Clin Oncol. 2016.


    a. DOI: 10.1056/NEJMoa1804710.

    *American Society of Clinical Oncology (ASCO) and ASCO are registered trademarks of ASCO; National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. ASCO and NCCN do not endorse any product or therapy

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