About the Oncotype DX Breast Recurrence Score® Test

Testing Core Biopsy Specimens

The COVID-19 pandemic has had a life-altering effect on the lives of the general population, but most notably health care providers and those with a diagnosis of cancer. We are all aware that in order to optimize provider, hospital, and clinic delivery of care, decisions are being made that are resulting in the postponement of both screening and diagnostic oncology services as well as elective surgery.

  • Our Oncotype DX® tests remain readily available and our laboratory continues to operate.
  • Core biopsies are the initial diagnostic procedure of choice for breast masses identified by physical exam or by imaging techniques.
  • The Oncotype DX test process was optimized to require only small amounts of tumor tissue and can be performed on a core biopsy of the breast cancer in lieu of the final resection specimen.
  • Guidance from the COVID-19 Pandemic Breast Cancer Consortium* references that a low-risk Recurrence Score® result from a core biopsy may be used to treat patients with Stage 1 or 2 disease, including N+ (1-3), with endocrine therapy alone when delaying surgery.a
  • View the new data on the molecular characterization of breast cancer needle core biopsy specimens by the 21‐gene Breast Recurrence Score test.
    Learn more about the COVID-19 Consortium recommendations for breast cancer treatment.
    Read a case study about "A 62-Year-Old Woman with Early Breast Cancer during the Covid-19 Pandemic" from the New England Journal of Medicine.

     

    Managing Breast Cancer During the COVID-19 Pandemic with the Oncotype DX Breast Recurrence Score Test

    Featuring speakers Christy Russell, MD (Sr. Medical Director, US Oncology) and Rick Baehner, MD (Chief Medical Officer, Precision Oncology)


    a. The COVID-19 Pandemic Breast Cancer Consortium. “COVID-19 Recommendations for Prioritization, Treatment and Triage of Breast Cancer Patients During the COVID-19 Pandemic.” The American Society of Breast Surgeons. Posted online April 7, 2020; Accessed April 9, 2020: https://www.breastsurgeons.org.
    * Includes representatives from ASBrS, NAPBC, NCCN, CoC, ACR

    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.



    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.




    REFERENCES

    1. Paik et al. N Engl J Med. 2004.
    2. Paik et al. J Clin Oncol. 2006.
    3. Albain et al. Lancet Oncol. 2010.
    4. Dowsett et al. J Clin Oncol. 2010.
    5. Habel et al. Breast Cancer Res. 2006.
    6. Toi et al. Cancer. 2010.
    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.
    14. Sparano et al. N Engl J Med. 2015.
    15. Petkov et al. npg Breast Cancer. 2016.
    16. Shak et al. ASCO QCS 2016.
    17. Gluz et al. J Clin Oncol. 2016.
    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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