Considerations for Extending Endocrine Therapy

  • Factors prognostic for late recurrence: tumor size and nodal status1,2
  • Patient characteristics: age, menopausal status, comorbidities
  • Initial adjuvant endocrine therapy regimen: TAM, AI, Sequence
  • Tolerability / Side Effects
  • Patient preference
  • Cost

First generation molecular tests are not validated for clinical decision-making regarding extending endocrine therapy3-10

  • Not validated as predictive for likelihood of benefit from extended endocrine therapy

Do Clinical and Pathological Factors Predict Extended Endocrine Benefit?

Standard molecular tools:

View an individualized approach

to assess likelihood of benefit from extended endocrine treatment

  1. Brewster AM et al. J Natl Cancer Inst. 2008;100(16):1179-83
  2. Sestak et al. J Natl Cancer Inst. 2013;105(19):1504-11
  3. Albain et al. Lancet Oncol. 2010;11:55-65.
  4. Paik et al. N Engl J Med 2004;351:2817-26.
  5. Sgroi D. et al. Lancet Oncol. 2013 Oct;14(11):1067-76.
  6. Desmedt C. et al. Clin Cancer Res. 2007;13:3207-14.
  7. Buyse M. et al. J Natl Cancer Inxt. 2006;98:1183-92.
  8. Lau KF. J Clin Oncol. 2009. 27:15s
  9. Wolmark N. et al. J Clin Oncol 32:5s, 2014 (suppl; abstr 11024).
  10. Paik S et al. J Clin Oncol. 23:16, 2005 (suppl; abstr 510).
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.