October 29, 2020
Biotheranostics' Breast Cancer Index™ IDEAL study expands clinical evidence for prediction of extended endocrine benefit to patients treated with aromatase inhibitors
SAN DIEGO, Calif., October 29, 2020. Biotheranostics announces the publication of results from the IDEAL study in Clinical Cancer Research which reports novel findings of the Breast Cancer Index (BCI) and predictive evidence in patients treated with aromatase inhibitors. In collaboration with Leiden University Medical Center in the Netherlands, the Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial examined the BCI HOXB13/IL17BR ratio (H/I) and its ability to predict benefit from extended endocrine therapyin 908 patients randomized to an additional 2.5 versus 5 years of extended endocrine therapy with letrozole after completing 5 years of therapy includingcombination tamoxifen/aromatase inhibitor or aromatase inhibitor monotherapy.
Findings from the study further strengthen the clinical evidence for the Breast Cancer Index as the endocrine response biomarker that identifies patients with improved outcomes as well as those who are not likely to benefit from longer durations of endocrine treatment. With practice changing data from the IDEAL study, BCI clinical evidence for endocrine prediction has been demonstrated in three distinct therapy groups - patients treated with Tamoxifen/Tamoxifen, Tamoxifen/Aromatase Inhibitor and now, for the first time, Aromatase Inhibitor/Aromatase Inhibitor. Consistent performance across multiple studies supports the comprehensive clinical utility of BCI in extended endocrine therapy decision-making, agnostic to background therapy with tamoxifen or aromatase inhibitors.
BCI is the only commercially available genomic assay with predictive evidence to inform the decision of extended endocrine therapy, allowing physicians to improve their ability to guide individualized patient care and joint decision making for women with HR+, early -stage breast cancer. Notably, 70% of women are diagnosed with HR+ breast cancer in the post-menopausal setting. The IDEAL study represents the first ever validation demonstrating prediction of patient benefit from extended aromatase inhibitor therapy following 5 year s of primary adjuvant treatment that included an aromatase inhibitor, the standard of care for post- menopausal patients. This newly published predictive data supports a significant increase in the number of women for whom BCI may assist in the decision to extend aromatase inhibitor therapy.
Catherine Schnabel, Ph.D., Chief Scientific Officer, Biotheranostics, said, "Results from the IDEAL study represent a major milestone for BCI in regards to evidentiary rigor and to better align its predictive utility to the standard of care for postmenopausal women with HR+ breast cancer."
Don Hardison, Biotheranostics' President and CEO adds, "We are thrilled that the Breast Cancer Index IDEAL study has been published in Clinical Cancer Research. This practice-changing studybroadens the evidence supporting the use of Breast Cancer Index for women with HR+, early-stage breast cancer faced with the decision of extending their endocrine therapy, regardless of treatment with tamoxifen or an aromatase inhibitor. We are fortunate to offer the only commercially available test that predicts benefit from extended endocrine therapy."
About Breast Cancer Index™
Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early stage, HR+ breast cancer. This breakthrough test helps oncologists and patients navigate the difficult trade-off between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. Breast Cancer Index holds guidelines designation from the American Joint Committee on Cancer for cancer staging based on molecular profile; ASCO, NCCN, European Group on Tumor Markers (EGTM), and St. Gallen to inform the chemotherapy decision; and ASCO and EGTM to inform the extended endocrine treatment dilemma. It is the only validated, commercially available test that provides risk of overall and late distant recurrence and predicts the likelihood of benefit from extended endocrine therapy. For more information, visit breastcancerindex.com.
Biotheranostics, Inc. operates a CLIA-certified and CAP-accredited diagnostic laboratory in San Diego, California. Biotheranostics, Inc., is a leading healthcare provider in the oncology field assisting physicians in the treatment of cancer patients. Its suite of proprietary molecular diagnostic tests provides important information to physicians to tailor treatment to individual patients. The company's Breast Cancer Index 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. Learn more at biotheranostics.com.