Breast Cancer Index® publishes new pivotal data strengthening clinical evidence as a predictive factor of benefit from endocrine therapy
SAN DIEGO, Calif., September 5, 2019 – Biotheranostics, Inc. today announced new pivotal data on the Breast Cancer Index® (BCI) published in the Annals of Oncology on August 28th 2019 further validating its ability to accurately predict which women with early-stage, hormone receptor positive (HR+) breast cancer will benefit from extended endocrine therapy. Findings from the Translational-aTTom study (Trans-aTTom) led by an international team of cancer researchers strengthen BCI clinical evidence as a predictive biomarker. Customizing treatment plans for each patient is an essential part of personalized care, and Breast Cancer Index provides physicians and patients with the necessary information needed to make appropriate individualized decisions.
The Trans-aTTom is a multi-institutional prospective retrospective Breast Cancer Index study of patients treated in the aTTom trial, which randomized nearly 7,000 HR+ women to either stop or continue tamoxifen for 5 more years after completing at least 4 years of tamoxifen therapy. Results from Trans-aTTom reported on 583 patients with N+ disease demonstrated that the Breast Cancer Index identified patients based on their response to extended endocrine therapy, stratifying 49% of patients that showed a statistically significant benefit of 10.2% with 10 years of tamoxifen, and 51% of patients that did not show a statistically significant benefit from continued treatment.
A significant dilemma for early-stage, HR+ breast cancer patients and their physicians is determining the optimal duration of endocrine therapy to reduce the ongoing risk of distant recurrence. For breast cancer patients on endocrine therapy, the side effects and toxicities associated with treatment often have a severe impact on health and quality of life (e.g., osteoporosis, endometrial cancer, blood clots, joint pain). Breast Cancer Index is the only test validated to predict which HR+ patients will benefit from endocrine therapy beyond 5 years, helping inform the decision of 5 vs 10 years of endocrine therapy. No other genomic tests or clinicopathologic factors demonstrate a significant ability to predict extended endocrine therapy benefit.
Catherine Schnabel, Ph.D., Chief Scientific Officer, Biotheranostics, said, “Findings from the Trans-aTTom represent the 4th study demonstrating a treatment to biomarker interaction for Breast Cancer Index and endocrine treatment. This unique ability of BCI to predict outcome and response to endocrine therapy drives its distinct clinical utility for patients with early stage HR+ breast cancer.”
Don Hardison, Biotheranostics’ President, and CEO added, “We are thrilled with the results and high impact publication of the Trans-aTTom study in the Annals of Oncology. Breast Cancer Index continues to provide critical information to breast cancer patients and their physicians as they make individualized treatment decisions regarding duration of 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, ER+ 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 www.breastcancerindex.com.
About Biotheranostics
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 www.biotheranostics.com.