BCI Prognostic Model Now Validated for LN+ patients (1-3 nodes)3

  • Developed with 209 HR+, early stage patients in the TransATAC cohort and validated in a blinded study of 402 patients with 1-3 positive nodes who were treated with adjuvant endocrine therapy and most with adjuvant chemotherapy3,4
  • BCI Prognostic Model integrates the BCI gene expression signature with tumor size and tumor grade to assess risk of late distant recurrence in ER+, early stage, LN+ patients (1-3 positive nodes)

BCI Prognostic LN- Validations

Breast Cancer Index (BCI) Prognostic Validations Included Multiple Treatment Histories, and Pre- and Post-menopausal Patients1, 2

Consistent stratification in two distinct risk categories:

  • 1,700 patients studied across three cohorts
  • Two validation studies in randomized prospective trial cohorts
  • Large proportion of patients (55% – 64 %) in all three cohorts classified as LOW risk

Distant Recurrence Rate from Years 5–10

*In clinical studies, BCI Intermediate had a statistically similar risk of late (5-10 year) recurrence as the BCI High risk group; thus risk categories for risk of late recurrence are reported as Low or High only

Prognosticating the risk of late distant recurrence

Clinically, BCI could allow many women with early-stage oestrogen-receptor-positive breast cancer to avoid unnecessary extended antihormonal treatment, and could be an important method to aid the management of residual risk after 5 years of adjuvant hormonal treatment.

– Sgroi et al, TransATAC study, Lancet Oncol, 20131

  • 1. Sgroi DC, et al. Lancet Oncol. 2013;14:1067 – 76.
  • 2. Zhang Y, et al. Clin Cancer Res. 2013;19:4196-4205.
  • 3. Zhang Y, et al. J Clin Oncol 34, 2016 (suppl abstr 541)
  • 4. Sestak et al. Cancer Res 2016;76(4 Suppl):Abstract nr P2-08-12.
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.

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