Clinical Validation of the Oncotype DX®
Breast Recurrence Score™

The Oncotype DX Breast Recurrence Score stands out for its clinical and utility studies with over 9,000 patients1-3, including six validation studies.

The test is the only genomic assay to fulfill the criteria for level 1 evidence4 for clinical use in patients with early-stage, hormone receptor-positive invasive breast cancer -- not only to assess the likelihood of distant breast cancer recurrence, but also to predict the benefit of adjuvant therapy.

This suite of clinical evidence demonstrates that the Breast Recurrence Score result can provide beneficial information beyond traditional clinical measures and standard pathology testing for both node-negative and node-positive breast cancer patients. Specifically, the validation studies show:

  • The Breast Recurrence Score result is strongly associated with the rate of distant recurrence, with a low score indicating a significantly lower 10-year rate of distant recurrence.5, 6
  • The Breast Recurrence Score result predicts the magnitude of benefit from chemotherapy, with a high score predicting a significant benefit from chemotherapy.7, 8

Therefore, use of the Breast Recurrence Score can spare patients the negative impact of unnecessary chemotherapy on health and quality of life and result in cost savings.9-12


The analytic validity, clinical validity, clinical utility of breast cancer diagnostic tests (like the Oncotype DX Breast Recurrence Score) are discussed by Dr. Jay K. Harness, Medical Director at, and Dr. Joseph Sparano, Associate Director, Clinical Research at the Albert Einstein Cancer Center; Associate Chairman, Medical Oncology at the Montefiore Einstein Center for Cancer Care.



1. Levine et al. ASCO 2014.
2. Burke et al. EBCC 2014.
3. Vacirca et al. ASCO 2013.
4. Simon et al. J Natl Cancer Inst. 2009.
5. Paik et al. N Engl J Med. 2004.
6. Dowsett et al. J Clin Oncol. 2010.
7. Paik et al. J Clin Oncol. 2006.
8. Albain et al. Lancet Oncol. 2010.
9. Hornberger et al. J Natl Cancer Inst. 2012.
10. Lo et al. J Clin Oncol. 2010.
11. Hornberger et al. Am J Manag Care. 2005.
12. Hornberger et al. J Oncol Pract. 2011.
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