bioTheranostics Release: Newly Published Data Expands Clinical Utility Of Breast Cancer Index To Include Early-Stage, ER+ Patients With Node Positive Disease

Published: Oct 11, 2017

SAN DIEGO, Oct. 10, 2017 /PRNewswire/ -- Biotheranostics today announced publication in the Clinical Cancer Research journal  of a study evaluating performance of a  Breast Cancer Index (BCI) that was specifically developed for early-stage, ER+ breast cancer patients with 13 positive lymph nodes.  These data expand BCI's clinical utility by demonstrating the test predicts the risk of distant recurrence from diagnosis through 15 years for earlystage, ER+ breast cancer patients with node positive disease.

In this study, 18% of earlystage, ER+ breast cancer patients with 13 positive lymph nodes that underwent adjuvant endocrine therapy had a 2.1% risk of recurrence after 15 years, underscoring the validity of Breast Cancer Index to assess the risk of the cancer coming back.

Lymph nodepositive breast cancer is associated with a higher risk of recurrence than lymph nodenegative breast cancer. Many oncologists recommend more aggressive therapeutic regimens including extending antiestrogen therapy for five additional years after completion of the first five years for these patients. Before these data, validated tools to help individualize this treatment decision for lymph-node positive patients had been lacking.

"These data are important for the nearly 20% of ER+ breast cancer patients that are nodepositive with 13 positive lymph nodes, and are generally considered to have a high risk of metastatic recurrence," said Dennis Sgroi, MD, Executive Vice-Chair and Director of Breast Pathology, Professor of Pathology, Harvard Medical School and lead investigator for this study.  "These data for BCI in nodepositive patients means that some of these patients who have already undergone chemotherapy and five years of endocrine therapy, will have a tool to personalize the shared decision with their doctor and to weigh the potential benefits of another five years of endocrine therapy vs. the potential risks."

Study Design and Results

The objective of this blinded study reported in Clinical Cancer Research was to independently evaluate a new BCI algorithm and prognostic model that combines gene expression with tumor size and grade in a large cohort of 402 early-stage, HR+ patients with 13 positive nodes. In patients who received tamoxifen or aromatase inhibitor therapy for up to 5 years, BCI classified 18% of patients as overall low risk with a 15year risk of metastatic recurrence of 2.1% vs a 15  year risk of 36.8% in the remaining patients (classified as the high-risk group). In the subset of patients who were disease free at year five, 22% were classified as low risk (2.1% overall risk of distant recurrence) vs the remaining patients, who had a risk of distant recurrence of 19%.  The study confirms BCI can offer valuable information to both physicians and patients considering extended endocrine treatment and indicates that  women with BCI low risk N1 disease might not require an additional five years of endocrine therapy.

Additionally, the BCI test result was the most significant factor for prognosticating overall and late-distance (post 5-yr) recurrence, when compared with age, progesterone receptor status, chemotherapy treatment, duration and type of endocrine treatment, and number of positive lymph nodes.

Don Hardison, president and CEO of Biotheranostics, said the data further demonstrate BCI's potential to improve the personalization of breast cancer treatment. "We are thrilled to see the continued evolution of BCI to help select the right women for extended endocrine therapy." Hardison said. "These results allow patients like this to have a more individualized discussion with their doctors about their risk of recurrence and recommended treatment after five years of endocrine therapy. Not every node positive patient is at significant risk of disease recurrence or should be treated in the same way."

About Breast Cancer IndexSM

BCI is a molecular, gene expressionbased test uniquely positioned to help identify earlystage, ER+ breast cancer 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 510). The breakthrough test helps oncologists and patients navigate the difficult tradeoff 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

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary molecular diagnostic tests that provide information to allow physicians to tailor treatment to individual patients. The company's CancerTYPE ID® is the most rigorously validated gene expression test for metastatic patients with diagnostic ambiguity, helping physicians determine optimal sitedirected treatment regimens with the goal of improving patient outcomes. Its Breast Cancer IndexSM helps oncologists make difficult decisions about extended endocrine therapy for early-stage, ER+ breast cancer patients based on its unique ability to predict risk of late disease recurrence and identify which patients are likely to benefit from continuing therapy beyond five years. Biotheranostics operates a CLIA-certified, CAP-accredited diagnostic laboratory in San Diego.  For more information, visit


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