The only validated test to help inform your decision to extend or end endocrine therapy1

Patients with HIGH Breast Cancer Index (BCI) predictive score

who received extended endocrine therapy achieved 67% relative risk reduction versus patients who took placebo (P = 0.007)

Patients with LOW Breast Cancer Index (BCI) predictive score

who received extended endocrine therapy had no significant benefit from extended endocrine therapy (P = 0.35)

Breast Cancer Index Predicted Endocrine Benefit in 3 Separate RCT

Risk of Recurrence in MA.17 Trial

Study Design

Study Design and Statistical Analysis Led by the National Cancer Institute of Canada (NCIC)1

  • Biomarker study designed as a case-control study to enrich for recurrences (study power based on number of recurrences)
  • The study cohort of 249 patients included 83 recurrences, representing >30% of recurrences from the parent trial
  • As a benchmark, this event rate approximates a population-based study of ~2,600 patients from the MA.17 parent trial
  • Cases from patients with recurrences were matched 1:2 with cases from patients that did not recur

Consistent Evidence as an Endocrine-Response Biomarker

Biomarker Study Design

Note: BCI Predictive was validated in a cohort that included both LN- and LN+ (1-3 nodes) patients􀀞; however the study was not designed or powered to assess LN-and LN+ groups separately.

Validated in a cohort from the MA.17 clinical study1

Prospective-retrospective study published in the
Journal of the National Cancer Institute (July 2013)

The MA.17 parent trial (N = 5,157) demonstrated, for the first time, the clinical benefit of extended endocrine therapy. However, there was a relatively small (4.6%) absolute benefit in the unselected population.1

References
  1. Sgroi DC, et al. J Natl Cancer Inst. 2013;105:1036-1042.
  2. Sgroi DC, et al. Cancer Res. 2012;72 (Suppl.): Abstract nr P2-10-15.
  3. Zhang Y, et al. Clin Cancer Res. 2013;19:4196-4205.
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.