Prospective study of 96 ER+ patients led by Yale University1

  • 26% of physician treatment recommendations related to extended endocrine therapy changed after Breast Cancer Index result
  • Breast Cancer Index resulted in net decrease in recommendations for extended endocrine therapy by 20% (from 74% to 54%)

Twice as many patients reported feeling strongly comfortable with their decision

~1/2 of Patients Reported:

  • A change in their treatment preference
  • Experiencing less anxiety (p=0.031), 13% had no change in anxiety

~2/3 of Patients Reported:

  • Decreased decisional conflict (p<0.001)
  • Knowing the results would make them more likely to be compliant with extended therapy
Breast Cancer Index has demonstrated the ability to specifically assess risk of late recurrence in ER-positive cancers…
…validated in 2 randomized trial cohorts as a prognostic tool for risk of late recurrence.

- Sanft T, et al. Breast Cancer Res Treat. 2015;154(3):533-41.

BCI also incorporates an endocrine response biomarker (HoxB13/IL17BR ratio [H/I]), which has been demonstrated in 3 randomized controlled trial cohorts to predict likelihood of benefit from endocrine therapy.

- Sanft T, et al. Breast Cancer Res Treat. 2015;154(3):533-41.

  1. Sanft T, et al. Breast Cancer Res Treat. 2015;154(3):533-41.
Breast Cancer Index Intended Use and Limitations

The Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test is intended for use in patients diagnosed with estrogen receptor-positive (ER+), lymph node-negative (LN-) or lymph node positive (LN+; with 1-3 positive nodes) early-stage, invasive breast cancer, who are distant recurrence-free. BCI provides: 1) a quantitative assessment of the likelihood of both late (post-5 years) and overall (0-10 year) distant recurrence following an initial 5 years of endocrine therapy (LN- patients) or 5 years of endocrine therapy plus adjuvant chemotherapy (LN+ patients), and 2) prediction of likelihood of benefit from extended (>5 year) endocrine therapy. BCI results are adjunctive to the ordering physician’s workup; treatment decisions require correlation with all other clinical findings.

This test was developed and its performance characteristics determined by Biotheranostics, Inc. lt has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. lt should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high complexity clinical laboratory testing.