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JENNIFER

Pre-menopausal
Year 2+

Background:

  • Age: 37
  • 8mm nodule
  • Core biopsy, grade 2, ER+/PR+
  • Oncotype Dx = 16
  • Stage: T1bN0
  • No chemotherapy
  • Endocrine therapy for 2 yrs 9mo
  • Experiencing side effects: decreased libido, irregular menses, pelvic pain

3.1% BCI LOW risk category in Years 5-10; LOW likelihood of benefit from extended endocrine therapy

Patient has decided to stop therapy after 5 years and would like to discuss considerations for getting pregnant

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Patrice

Pre-menopausal
On tamoxifen for 5 years
Experiencing bothersome side effects

Background:

  • Age: 42
  • 2009: diagnosed
  • 1.7cm tumor, ER+/PR-, RS = 12
  • Adjuvant TAM for 5 years
  • Reports struggling with hot flashes, inability to sleep, and lower libido
  • BCI test ordered

HIGH risk, HIGH likelihood of benefit

Doctor recommends continuing extended endocrine therapy and routine office visits annually with patient's involvement in survivorship program to help manage history of poor compliance

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Harriet

Pre-menopausal
Continual AI side effects
Worried about stopping therapy

Background:

  • Age: 63
  • 2008: diagnosed
  • 1.5cm, grade II lesion
  • Node negative
  • ER+/PR+, HER2+ by FISH
  • Received chemotherapy with Herceptin®
  • 2009: Armidiex®
  • Developed significant migraines; switched to Femara®, but did not tolerate
  • Switched to Aromasin®; stayed on until 2013
  • Started having UTIs almost monthly

4.3% BCI LOW risk category in Years 5–10; LOW likelihood of benefit from extended endocrine therapy

Patient anxious about recurrence: BCI gave her peace of mind to stop AI therapy rather than continue one year at a time until NSABP B42 trial completion

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Susan

Pre-menopausal
Year 5
Informed patient

Background:

  • Age: 65
  • T2N0 intermediate, KI67 5%
  • Oncotype Dx = 28 (Intermediate Score)
  • Treated with chemotherapy + 5yr TAM
  • Has RA and a cardiomyopathy at her 5 year mark of TAM
  • Very risk averse
  • 20lb. weight gain
  • Difficulty distinguishing TAM side effects from other medical issues
  • Because of tumor size and OncotypeDx score, original decision
    was to continue on TAM

4.3% BCI LOW risk category in Years 5–10; LOW likelihood of benefit from extended endocrine therapy

Patient chose not to continue on tamoxifen

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Bella

Pre-menopausal
Beyond 5 years
Experiencing significant aromatase inhibitor (AI) side effects

Background:

  • Age: 61
  • 2007: diagnosed (Stage IIa)
  • 2.1cm tumor, ER+/PR+/LN-, HER2-
  • No Oncotype DX® performed
  • 4 cycles adjuvant TC followed by XRT at lumpectomy site (out of state)
  • Initiated endocrine therapy, TAM (premenopausal), cessation of menses
  • 2011: documented menopause and changed to AI
  • Complained of arthralgia and struggled with rotator cuff issues
  • Expressed desire to be more mobile to help husband diagnosed with Stage IV lung cancer
  • 2014: BCI test ordered (6 years endocrine therapy)

3.7% BCI LOW risk category, LOW likelihood of benefit

Decision to stop therapy

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Denise

Pre-menopausal
Year 7

Background:

  • Age: 54
  • 2007: diagnosed
  • 2.3 cm tumor in right breast
  • Node negative, ER+, HER2-
  • Oncotype RS = 19
  • No chemotherapy
  • 5 years TAM
  • Stopped 2 years ago
  • Reconsidering resuming endocrine therapy based on randomized trial results

7.4% BCI HIGH risk category in Years 5-10; HIGH likelihood of benefit from extended endocrine therapy

Patient is now post-menopausal and physician has recommended AI treatment for 5 years

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Robin

Pre-menopausal
Year 7.5

Background:

  • Age: 52
  • 1.6cm tumor, grade 2
  • Stage: T1cN1 (.25mm met)
  • WLE, radiation
  • Treated with chemotherapy
  • Tamoxifen x 5yrs, aromasin 2.5 yr
  • Experiencing side effects: decreased libido, achiness, vaginal dryness

6.6% BCI HIGH risk category in Years 5–10; HIGH likelihood of benefit from extended endocrine therapy

Patient chose to continue treatment and may go back to tamoxifen

Note: BCI Prognostic was validated in a cohort that included LN- patients only. Any LN+ patient should be viewed as higher risk and be managed accordingly.

References
  1. Gustavesen G, et al. Am J Manag Care. 2014;20:e302-e310.
Breast Cancer Index Intended Use and Limitations

BCI provides a quantitative assessment of the likelihood of distant recurrence in patients diagnosed with ER+ node-negative breast cancer, and prediction of likelihood of benefit from extended (>5 year) endocrine therapy in patients who are recurrence-free after an initial 5 years of adjuvant endocrine therapy. 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.