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Clinical Trial Using Proteomics Technologies for Personalized Medicine Approach to Breast Cancer

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This story originally ran on March 9 and has been updated to provide more details and comment.

A new clinical trial is using proteomics technologies to help guide doctors to make personalized treatment regimens for patients with breast cancer.

The trial, which is funded by the Side-Out Foundation, is being managed by TGen Drug Development, a partnership between the Translational Genomics Research Institute and Scottsdale Healthcare to bring genomics and proteomics discoveries made by TGen and others to the bedside.

Side-Out was founded in 2004 to raise money to support research and other efforts against breast cancer.

The trial is being conducted at TGen Clinical Research Services at Scottsdale Healthcare in Scottsdale, Ariz., and Fairfax Northern Virginia Hematology Oncology in Fairfax, Va. Over the 24 months of the trial, physicians will be provided information and recommendations for treatments of patients with metastatic breast cancer.

The pilot study, begun on Feb. 15, applies technologies from Caris Life Sciences and George Mason University's Center for Applied Proteomics and Molecular Medicine to analyze diseased tissues from up to 25 patients and create proteomic profiles for each patient. That information will then be used to help determine what treatments work best for each patient.

The trial is a follow-up to the Bisgrove Study, which was presented a year ago at the American Association for Cancer Research. The study showed that a personalized medicine-based approach using a molecular profile of a patient's cancer could improve the survival rate of cancer patients.

With the current trial, which is listed on the National Cancer Institute Clinical Trial Directory, researchers will go "beyond molecular profiling to introduce mapping proteomic pathways with the tumor tissue so each patient can receive a highly targeted regimen designed to impede their cancer growth," according to a statement from Side-Out.

Researchers at George Mason's CAPMM will use a reverse-phase protein microarray technology developed by Lance Liotta and Emanuel Petricoin to test every targeted therapy for cancer that has been approved by the US Food and Drug Administration, 13 in all, to determine whether they are effective against breast cancer, Petricoin told ProteoMonitor in January.

In an e-mail, Alan Wright, senior vice president of strategy at Caris, said his firm will be using its Target Now approach in the trial. The approach combines immunohistochemical staining of pathology specimens to measure protein expression and techniques to measure the expression and use of genetic information on the same speciments.

"The information provided is vetted against a review of the cancer clinical literature by Caris' Evidence Team for results shown to be associated with response or non-response to chemotherapeutic agents," Wright said.

This will provide the oncologist with "personalized treatment options" in treating their patients with breast cancer, he said.