5,500-plus Breast Cancer Patient Tumor Profiling Study Suggests Potential Biomarker Targets in Therapy Selection for Triple Negative Breast Cancer (TNBC)

Mutational status and protein analysis both key to better understanding possible treatment implications for difficult-to-treat disease

Irving, Tex., Dec. 12, 2013 — Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, presented a breast cancer study at the 2013 CTCR-AACR San Antonio Breast Cancer Symposium held this week in San Antonio, Texas. The analysis focuses on identifying potentially actionable therapeutic targets and clinical strategies for triple negative breast cancer (TNBC), an aggressive, difficult-to-treat cancer that accounts for roughly 10 to 15% of all breast cancers in the U.S. The biomarker data utilized for this study was obtained using the company’s comprehensive tumor profiling service, Caris Molecular Intelligence™. The study’s findings were presented by lead author Joyce O’Shaughnessy, M.D., from Baylor Sammons Cancer Center, in a poster discussion on Thursday, Dec. 12 at 5 p.m. CST in Ballroom B.
“While metastatic triple negative breast cancer may be responsive to chemotherapy, it is very challenging to treat, as there are very few proven targeted therapies for this cancer sub-type,” said Dr. O’Shaughnessy. “The data presented in this study contributes to the growing body of research dedicated to uncovering new or unconsidered therapeutic targets and strategies for TNBC patients.”
The study, “Comparison of Mutations and Protein Expression in Potentially Actionable Targets in 5,500 Triple Negative vs. Non-Triple Negative Breast Cancers,” profiled a large database of breast cancer tumors (with TNBC tumors accounting for 35.8%) to identify potential molecular differences between sub-types as well as to find potential druggable targets for TNBC.  Mutational analysis, protein expression and gene copy number assessment were utilized in the analysis, sequencing (next-generation sequencing and Sanger), immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and chromogenic in situ hybridization (CISH) were all necessary to obtain the study’s results.
Notable findings include:

  • Androgen Receptor (AR) was expressed in 50% of ER-/HER2+ breast cancer patients and 18% of TNBC patients studied, indicating its potential as a therapeutic target
  • Nearly all AR+ breast cancers displayed a PIK3CA mutation or PTEN loss/mutation, suggesting that combined AR and PIK3CA targeted therapies should be evaluated as a potential therapeutic strategy
  • EGFR gene amplification differed between breast cancer types and may need to be considered as a predictive marker in clinical trials of EGFR inhibitor therapies
  • Multi-platform molecular profiling is needed to identify targetable genomic and proteomic alterations in poor prognosis breast cancer

“Protein expression analysis by immunohistochemistry (IHC) in particular, provided some potentially important clinical insights for oncologists treating TNBC patients,” said Zoran Gatalica, M.D., DSc, Executive Medical Director at Caris Life Sciences. “For patients with very limited therapeutic options and/or aggressive disease, like those diagnosed with TNBC, Caris’ holistic approach to molecular profiling is critically important, as it provides both genomic and proteomic analyses of their cancer’s molecular alterations.”
About Caris Molecular Intelligence
Caris Molecular Intelligence™ has been the leading cancer profiling service on the market since 2006, having been used for more than 50,0000 cancer patients and counting by more than 6,000 oncologists in at least 58 countries to help develop individualized and actionable treatment plans to improve patient care.  Caris Molecular Intelligence™ utilizes the most comprehensive range of analytical technologies endorsed by the latest and most robust evidence — immunohistochemistries, fluorescence and chromogenic in situ hybridization, polymerase chain reaction and Next-Generation sequencing – to provide oncologists the most complete and clinically relevant profile of a patient’s unique cancer-related biomarkers. Unlike other commercially available tumor profiling services, Caris Molecular Intelligence™ more completely interrogates a patient’s unique tumor biology by going beyond just DNA analysis. The service assesses additional important biological components like RNA and protein expression levels to establish a multi-dimensional profile of a patient’s tumor that reveals more fully the complex biological processes driving that patient’s cancer and, therefore, more, relevant targets for potential clinical action.
With a multi-dimensional profile of a patient’s unique tumor, Caris Molecular Intelligence integrates insights from its proprietary and industry-leading evidence curation and bioinformatics platform to identify and report the most clinically relevant associations to drug therapies that are approved by the U.S. Food & Drug Administration or are in active clinical trials in the U.S. Managed by the Caris Evidence Design Board, a dedicated team of oncology experts that includes 5 Ph.D.s and 6 M.D.s, the Caris Molecular Intelligence evidence and bioinformatics platform curates, classifies and catalogues the findings and evidence from all relevant clinical studies in cancer and cancer biology available in the published scientific and medical literature, using a methodology adapted from the evidence review process of U.S. Preventive Services Task Force ( of the Agency for Health Research and Quality (  This platform incorporates the review of more than 100,000 publications and counting.  Relying on the most robust evidence that meets Caris’ quality standards, the Caris Molecular Intelligence evidence and bioinformatics platform can currently provide therapeutic guidance for up to 43 drug associations with Caris’ multi-dimensional approach to tumor profiling, far exceeding the 12 that can be identified using next-generation sequencing alone.  This platform electronically delivers the profile and results in an easy-to-use report format that gives oncologists access to underlying evidence, enabling them to develop tailored treatment plans for each unique patient. For more information on Caris Molecular Intelligence™, visit
About Caris Life Sciences
Caris Life Sciences is a leading biosciences company focused on fulfilling the promise of personalized medicine.  As the first commercial mover in comprehensive molecular profiling in oncology, Caris Molecular Intelligence™ is an industry vanguard, with 50,000-plus patients profiled and counting. Ordered by nearly 6,000 oncologists in 58 countries, Molecular Intelligence correlates molecular data generated from a patient’s tumor with biomarker/drug associations derived from clinical cancer literature. Using a variety of advanced and clinically-relevant technologies, Caris provides oncologists with the most clinically actionable information to help them personalize treatment for cancer patients. This multi-technology approach enables Caris to provide therapeutic guidance for 43 drug associations, compared to the 12 that can be found through use of next-generation sequencing alone. The company is also developing a series of blood tests based on its proprietary Carisome® platform — a revolutionary blood-based testing technology for diagnosis, prognosis, and theranosis of cancer and other complex diseases. Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe, Australia and other international markets. To learn more, please visit

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