Extended 10-year treatment poses major safety and tolerability challenges1-3

Some patients are unlikely to experience benefit from extended endocrine therapy and may endure years of safety risks and side effects. Do you know which patients are likely to benefit?

Patient Compliance and Treatment Challenges with Extended Endocrine Therapy

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Results from the ATLAS trial (tamoxifen) help define the benefits and costs of extended endocrine therapy1:

For every 600 women treated with extended endocrine therapy for ER+ early stage breast cancer...

Similar trade-off for patients considering extended therapy with aromatase inhibitors exists. As demonstrated in the MA.17 Trial3,4 (Extended letrozole vs placebo), for every 600 women treated, 12 recurrences were prevented at the cost of 13 new cases of osteoporosis, 4 bone fractures, 1 thromboembolic event.

PLUS greater than 50% of women treated with AI experience tolerability challenges which may impact QOL.6-10

Breast Cancer Index - THE endocrine biomarker, is the only test which provides clinically actionable information that can impact her treatment plan beyond Year 55

When deciding whether to extend endocrine therapy, also consider:

  1. Davies C, et al. Lancet Oncol. 2013;381:805-816.
  2. Jakesz R, et al. J Natl Cancer Inst. 2007;99:1845-1853.
  3. Goss PE, et al. J Natl Cancer Inst. 2005;97:1262-1271.
  4. Goss PE et al. N Engl J Med. 2003;349. 5.
  5. Sgroi DC, et al. J Natl Cancer Inst. 2013;105:1036-1042.
  6. Femara prescribing information, January 2014.
  7. Crew KD, et al. J Clin Oncol. 2007 Sep 1;25(25):3877-83.
  8. Arimidex prescribing information. http://www1.astrazeneca-us.com/pi/arimidex.pdf
  9. Fallowfield LJ, et al. Breast Cancer Res Treat. 1999;55(2):189-99.
  10. Aromasin prescribing information.
  11. Nolvadex (tamoxifen citrate) product information. AstraZeneca Pharmaceuticals, 8-27-04.
  12. Conzen, SD. Managing the side effects of tamoxifen. In: UpToDate, Dizon DS (Ed), UpToDate, Waltham, MA. (Accessed on March 11, 2015.)
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.