LOW risk (3.7%), LOW likelihood of benefit
- Decision to stop therapy
- Patient doing well
Understanding the
Unmet Need
Unmet Need
Major Safety and
Tolerability Challenges Unnecessary Exposure to
Extended Endocrine Therapy Side Effects Lead
to Noncompliance
Tolerability Challenges Unnecessary Exposure to
Extended Endocrine Therapy Side Effects Lead
to Noncompliance
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PROGNOSTIC STUDIES
PREDICTIVE STUDIES
Tour the Test Report
Prognostic Score
- 0 - 10
- Individualized risk of late recurrence*
*If ordered at time of diagnosis, test report also provides overall (years 0-10), early (0-5 year), and late (5-10 year) risk of recurrence
PROGNOSTIC STUDIES
Predictive Score
- Predictive of likelihood of benefit from extended endocrine therapy
- HIGH or LOW (binary result)
PREDICTIVE STUDIES
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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)
SEE HER BCI TEST RESULTS
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
SEE HER BCI TEST RESULTS
HIGH risk, HIGH likelihood of benefit
Doctor recommends continuing extended endocrine therapy and routine office visits annually with patients involvement in survivorship program to help manage history of poor compliance
Post-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: Armidi®
- Developed significant migraines; switched to Femara®, but did not tolerate
- Switched to Aromasin®; stayed on until 2013
- • Started having UTIs almost monthly
- 2009: Armidi®
SEE HER BCI TEST RESULTS
4.3% LOW risk of recurrence 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
Post-menopausal
Year 5
Informed patient (physician and breast radiologist)
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
SEE HER BCI TEST RESULTS
4.3% LOW risk of recurrence in Years 5 – 10; LOW likelihood of benefit from extended endocrine therapy
Patient chose not to continue on tamoxifen
Peri-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
SEE HER BCI TEST RESULTS
6.6% HIGH risk of recurrence in Years 5 – 10; HIGH likelihood of benefit from extended endocrine therapy
Patient will continue treatment and may go back to tamoxifen
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 of side effects: decreased libido, irregular menses, pelvic pain
SEE HER BCI TEST RESULTS
3.1% LOW risk of recurrence 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 get pregnant
Post-menopausal
Year 7
Experiencing significant
aromatase inhibitor (AI) side effects
- Age: 54
- 2007: diagnosed
- 2.3 cm tumor in right brea
- Node negative, ER+, HER2-
- Oncotype RS = 19
- 5 years TAM
- Stopped 2 years ago
- Reconsidering resuming endocrine therapy based on randomized trial resul
SEE HER BCI TEST RESULTS
7.4% HIGH risk of recurrence 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
References
- Sgroi DC, et al. Lancet Oncol. 2013;14:1067 – 76.
- Sgroi DC, et al. J Natl Cancer Inst. 2013;105:1036-1042.
- Zhang Y, et al. Clin Cancer Res. 2013;19:4196-4205.
Breast Cancer Index Indications for 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.