Study Suggests that BCI May Help Physicians Identify T1N0 Patients for Extended Endocrine Therapy

- Molecular resolution of tumor biology identified significant subsets from traditionally classified low risk patients as higher risk of breast cancer recurrence

- Sub-group analyses of patients classified as low risk by traditionally performed risk assessments indicated that up to 22 percent of patients are at high risk for early recurrence (0-5 years) and as many as 36 percent of patients are at high risk for late recurrence (after 5 years)

- Presented at the San Antonio Breast Cancer Symposium Annual Meeting, these data support a need to individualize anti-estrogen treatments based on a patient's tumor biology vs. relying only on traditional approaches

 

FOR IMMEDIATE RELEASE…December 8, 2016…SAN DIEGO… Results from new analyses of two cohorts demonstrate that Breast Cancer Index (BCI), a genomic biomarker performed by Biotheranostics, Inc., identifies patients with early-stage estrogen receptor-positive (ER+) breast cancer who are at risk for early and late disease recurrence and adds molecular resolution to traditional factors of tumor size and nodal status. In both study cohorts, as many as one in five patients with low risk clinical features were at high risk of early recurrence and might benefit from adjuvant chemotherapy. Additionally, in both cohorts, more than one-third of patients were at >10% risk of a late distant recurrence after 5 years and therefore might benefit from extending anti-estrogen therapy beyond five years.

"The results of the large randomized trials of extended endocrine therapy presented at SABCS, including NSABP B-42, reinforced what we've known -- that predictive biomarkers are critical for patient selection for extended durations of endocrine therapy," said Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics. "Indeed, patients with T1-sized tumors that are node negative (T1N0) are generally thought to have a low risk of distant recurrence and an overall favorable prognosis. However, our study of these patients demonstrated that traditional clinicopathological factors may not provide the complete picture, and the Breast Cancer Index can help identify a number of patients at high risk of distant recurrence who may benefit from extended endocrine therapy, and who would typically not be considered at risk. The importance of the use of biomarkers, like BCI, cannot be understated."

These data will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. BCI is developed and marketed by Biotheranostics, Inc., a pioneer in molecular diagnostics for cancer.

Investigators conducted analyses of nearly 500 patients from two cohorts where risk of distant recurrence was assessed in patients with small tumors (T1) and node negative disease—traditionally considered features that are associated with a low risk of disease relapse. In one cohort, BCI identified 22% of T1N0 patients as High Risk for relapse within the first 5 years, and these patients had a significantly reduced distant recurrence-free survival (DRFS, 77.3%) compared to BCI Low Risk patients (96.2%; P=0.0001). In patients who were disease-free at year 5, BCI identified 36% of patients as high risk for late recurrence; these patients had significantly lower DRFS (89.6%) between years 5-10 compared to BCI low risk patients (98.4%; P=0.008).

"These analyses further support our knowledge that BCI can help many patients with ER+, early-stage breast cancer better mitigate their long-term risk of tumor recurrence with proactive and appropriate use of extended anti-estrogen therapy," added Dr. Schnabel. "As we continue to analyze the results of these studies, we become more and more confident that adding Breast Cancer Index to traditional clinical and pathological factors to assess risk, could be the difference between lasting remission and tumor recurrence for as many as one in every three early stage patients with ER+ tumors."

About Breast Cancer IndexSM

BCI is a molecular, gene expression-based test uniquely positioned to help identify patients best suited for extended endocrine treatment. It is the only validated, commercially available test with data demonstrating prognostic risk of recurrence out to 15 years, as well as prediction of likelihood of benefit from extended endocrine therapy (treatment in years 5-10). The breakthrough test helps oncologists and patients navigate the difficult trade-off between wanting to take steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to extended endocrine therapy. For more information, visit breastcancerindex.com.

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary genomics-based molecular diagnostics that allow treatment to be tailored to individual patients. The company's Breast Cancer IndexSM and CancerTYPE ID® tests address a variety of unmet medical needs in the management of cancer patients, and extensive clinical studies have confirmed the accuracy, clinical validity, clinical utility, and cost-effectiveness of the tests. Biotheranostics operates a CLIA-certified, CAP-accredited diagnostic laboratory in San Diego. Learn more at biotheranostics.com.

 

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.

Biotheranostics Page

Biotheranostics, Inc. | 9640 Towne Centre Drive | Suite 200 | San Diego, CA 92121 | Biotheranostics.com

US and International: +1 (858) 587-5870 | Fax: +1 (800) 266-9607 | Client Services: +1 (877) 886-6739 | Billing Information: +1 (888) 286-0755 | Patient Advocates Team: +1 (844) 319-8111

© 2018 Biotheranostics, Inc. Breast Cancer Index and BCI are service marks of Biotheranostics, Inc.