Breast Cancer Index is now recognized in ASCO guidelines at diagnosis to assist in the decision regarding adjuvant systemic therapy for ER+, HER2-, LN- patients

Breast Cancer Index provides prognostic information for your patient, identifying a group with good outcomes on endocrine therapy alone.


The unmet need at diagnosis

A major challenge in early-stage breast cancer care has been to accurately assess the risk of disease recurrence in individual patients in order to make appropriate adjuvant treatment decisions. For example, while clinical trials have demonstrated the benefits of adjuvant chemotherapy across a population of ER+, early-stage breast cancer patients, the vast majority of individual patients will not benefit from chemotherapy. Specifically, the proportion of patients without disease recurrence only increases by approximately 4% in ER+, LN- patients treated with chemotherapy in addition to tamoxifen.2 The decision to undergo adjuvant chemotherapy is difficult for many patients and physicians, as patients treated with chemotherapy can experience a range of serious short- and long-term toxic side effects.


Breast Cancer IndexSM (BCI) is designed and validated to provide a quantitative prediction of the risk of distant recurrence between years 0-10 in patients diagnosed with early-stage ER+, LN- breast cancer.

Breast Cancer Index provides an individual risk of overall distant recurrence (years 0-10). Breast Cancer Index Prognostic is reported as a score on a scale of 0 to 10, which corresponds to a specific percent risk of distant recurrence for each patient. The patient’s risk of recurrence is also categorized as Low, Intermediate, or High Risk, based on pre-specified cut points.

For example, in the graph below, a score of 2 translates to 3.2% risk of distant recurrence in years 0-10 in patients treated with adjuvant endocrine therapy only.4


Below is an example of a sample test report.

The risk of recurrence (shown as a percentage) is clearly called out on the test result.


For patients found by Breast Cancer Index Prognostic to have a low risk of distant recurrence, physicians may correlate these results with other clinical information and consider allowing these patients to forego adjuvant chemotherapy, sparing them the risk of serious short- and long-term toxic side effects associated with chemotherapy.

Clinical practice guidelines

Breast Cancer Index has recently been recommended in the ASCO Clinical Practice Guidelines for this use.1


Substantiating data

Breast Cancer Index Prognostic for Adjuvant Chemotherapy Decision-Making:

Breast Cancer Index has established Level 1b evidence for clinical utility per the criteria established by Simon and colleagues (J Natl Cancer Inst. 2009 101:1446-52).
      – Breast Cancer Index is validated as a prognostic biomarker for risk of overall distant recurrence in 2 studies.

Summary of validation studies3-4

  • 982 patients studied across two cohorts
  • Two validation studies in randomized prospective trial cohorts
  • Large proportion of patients classified as LOW RISK [(Breast Cancer Index classified 55% - 64% as Low risk); these patients had a <5% risk of 10-y distant recurrence across studies)]

Distant Recurrence Rate from Years 0-10

Stockholm study
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– In the Stockholm prospective randomized controlled trial cohort (ER+, LN- patients treated with adjuvant tamoxifen only), Breast Cancer Index Prognostic stratified 64% of patients as low risk, 20% as intermediate risk, and 16% as high risk.4

  • Breast Cancer Index Prognostic was significantly prognostic (P=0.0001), with 10 year rates of distant recurrence (0-10y) of 4.8%, 11.7%, and 21.1% in the Breast Cancer Index Low, Intermediate, and High risk groups, respectively.
TransATAC study
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– In the TransATAC prospective randomized controlled trial cohort (ER+, LN- patients treated with either 5 years of tamoxifen or 5 years of the aromatase inhibitor (AI) anastrozole only), Breast Cancer Index Prognostic stratified 59% of patients as low risk, 25% as intermediate risk, and 16% as high risk.3

  • Breast Cancer Index Prognostic was significantly prognostic (p<0.0001), with 10 year rates of distant recurrence (0-10y) of 4.8%, 18.3%, and 29% in the Breast Cancer Index Low, Intermediate, and High risk groups, respectively

Comparative studies

– In a multivariate analysis from the TransATAC cohort that compared BCI to Oncotype Dx® and IHC4, BCI was the strongest prognostic factor for recurrence from 0-10y (BCI HR=2.30, 95% CI, 1.62-3.27; Oncotype HR=1.48, 95% CI) 1.22-1.78).3


– Breast Cancer Index has also been shown to re-stratify Recurrence Score risk groups for distant recurrence with clinical and statistical significance.4-5

  • Sestak, et al., directly compared prognostic accuracy, agreement and clinical significance of cross stratification by the RS and Breast Cancer Index at the individual patient level
  • Breast Cancer Index re-stratified women with low or intermediate risk for distant recurrence by the Recurrence Score into clinically relevant different risk groups with significantly different risk of distant recurrence at 10 years of follow-up.(P<0.001, P=0.003, respectively)
    • Breast Cancer Index reclassified 53% of Oncotype DX RS intermediate to low risk with a 10-year risk of distant recurrence of 7.1%
    • Breast Cancer Index reclassified 19% of Oncotype DX RS intermediate into high risk with a 10-year risk of distant recurrence of 27.8%

References
  1. Harris, et al., J Clin Oncol Feb 2016.
  2. Fisher B, Dignam J, Wolmark N, et al. J Natl Cancer Inst. 1997;89:1673-82.
  3. Sgroi DC, et al. Lancet Oncol. 2013; 14:1067-1076.
  4. Zhang Y, et al. Clin Cancer Res. 2013;19:4196-4205.
  5. Sestak et al. Clin Cancer Res. 2016.

Breast Cancer Index Intended Use and Limitations

The Breast Cancer Index (Breast Cancer Index) 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. Breast Cancer Index 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. Breast Cancer Index 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.