Biotheranostics Announces Inclusion of Breast Cancer Index in the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines for Prediction of Benefit from Extended Endocrine Therapy

Press Room

December 17, 2020

Breast Cancer Index demonstrates its ability to predict preferential endocrine benefit irrespective of risk for HR+ early-stage breast cancer patients

 

SAN DIEGO, Calif., December 17, 2020. Evidence demonstrating the ability of Breast Cancer Index to predict preferential endocrine benefit irrespective of clinical risk for HR+ early-stage breast cancer patients was highlighted during a Spotlight session on December 9th at this years' San Antonio Breast Cancer Symposium. The Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial examined the Breast Cancer Index (BCI) HOXB13/IL17BR (H/I) ratio and its ability to predict benefit from extended endocrine therapy. The IDEAL study randomized patients to an additional 2.5 versus 5 years of extended letrozole after completing 5 years of endocrine therapy with tamoxifen or aromatase inhibitors (AIs) or a sequence of tamoxifen and AI.

The study, which evaluated patient subsets based on risk, underscored the important role of tumor biology, showing that BCI as a molecular signature of endocrine responsiveness predicted which patients benefited from a full 10 vs 7.5 years of endocrine treatment vs those that did not benefit. BCI identified clinically low-risk patients (N0 or N1 & T1 or Grade 1) who derived significant benefit from 10 years of endocrine therapy (BCI-H/I High P=0.004). BCI also identified patients with clinically high-risk disease (N+/T2+) who did not benefit from extended letrozole (BCI-H/I Low P=0.742).

Results emphasized that clinical or genomic risk were not sufficient to identify patients with improved outcomes from extended endocrine therapy, making BCI imperative to the clinical question of individualizing continuation or de-escalation of treatment. Study results from IDEAL, published recently in the Clinical Cancer Research journal, represent the first data published on BCI's ability to predict benefit from extended AI therapy following 5 years of primary adjuvant AI therapy. These data add to the already significant body of evidence demonstrating the predictive ability of BCI, further establishing the test as the only commercially available multi-gene expression assay with validated predictive data.”

"The presentations at SABCS confirm again that for our HR+ patients with early-stage breast cancer, the Breast Cancer Index is hands down the best tool available to counsel our patients regarding the risk for a late recurrence and for benefit of extended endocrine therapy beyond 5 years.” VK Gadi, MD PhD, Breast Cancer Physician and Professor, University of Illinois Cancer Center."

Peter Beitsch, MD, shares his thoughts on Breast Cancer Index, "There has been a trend toward treating all women with hormone receptor positive breast cancer with 10 years of endocrine therapy even though the absolute benefit is only ~4%. The Breast Cancer Index (BCI) allows us to sort out the patients who will benefit from extended endocrine therapy from those who will not (but who will suffer the harms). Extended endocrine with benefit - absolutely. Extended endocrine without benefit - why treat? BCI is precision medicine at its finest!"

Don Hardison, Biotheranostics' President and CEO adds, "Breast Cancer Index has become a best-in-class genomic tool for HR+ early-stage breast cancer patients and their health care providers who are faced with challenging clinical decisions on 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, 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.

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 biotheranostics.com.