Effort Aims to Spike Breast Cancer With New Approach

Virginia G. Piper Cancer Center, Side-Out Foundation team up for 'next generation' treatment

SCOTTSDALE, Ariz., March 11 /PRNewswire-USNewswire/ -- Many women live with breast cancer that does not respond to standard medical treatment, a condition that researchers at the Virginia G. Piper Cancer Center at Scottsdale Healthcare want to change by aggressively targeting specific genes.

Improving quality of life and potentially keeping the cancer under control for a longer period of time are goals of a new clinical trial at the cancer center's TGen Clinical Research Services, a partnership of Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

The pilot study is supported by the Side-Out Foundation, a group founded by volleyball enthusiasts to help wage war on breast cancer.

Women or men with advanced breast cancer that has progressed through three prior treatments are eligible for the trial, available in the western U.S. only at Scottsdale Healthcare's Virginia G. Piper Cancer Center.

"Many are living with refractory, or advanced, breast cancer that has not responded or continues to grow despite standard treatments," explains Nurse Practitioner Gayle Jameson, principal investigator. "What we are offering here is a whole new approach for treating patients with refractory breast cancer."

Biopsied tissue will be analyzed for unique characteristics and abnormal genes in cancer cells, which are then targeted for treatment with FDA-approved anticancer medications. "We may discover that a tumor has a gene mutation that responds to a drug not typically used in a 'one-size-fits-all' approach," explains Jameson.

"What we are doing here is precisely matching a treatment to a specific type of cancer cell mutation and abnormal protein signaling pathways that may activate cancer cell growth. The patient would then be treated with one or more medications based on the information provided by the analyses."

Researchers call the Side-Out study the "next generation of breast cancer treatment," expanding on what was learned about molecular profiling in an earlier clinical trial at the Virginia G. Piper Cancer Center. The new study, managed by TGen Drug Development (TD2), is open to a total of 25 patients at only two sites, the Virginia G. Piper Cancer Center at Scottsdale Healthcare and Fairfax Northern Virginia Hematology Oncology.

Results of the earlier trial, known as the Bisgrove Study, showed that molecular profiling can identify specific treatments that help keep cancer in check for significantly longer periods, and in some cases even shrinking tumors. Clinical trials at the cancer center are administered by the Scottsdale Healthcare Research Institute.

Research at the Virginia G. Piper Cancer Center at Scottsdale Healthcare allows molecular and genomic discoveries to reach the patient bedside as quickly as possible through clinical trials of therapies directed at specific targets in patients' tumors.

Established in 2004, the Side-Out Foundation's mission is to raise money for the war against breast cancer through the sport of volleyball. Major contributing laboratories in the Side-Out study are CARIS Diagnostics, and George Mason University's Center for Applied Proteomics and Molecular Medicine.

Patients seeking additional information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact research patient care coordinator Joyce Schaffer, RN, at 480-323-1339, toll free at 1-877-273-3713 or at [email protected].

About TGen Clinical Research Services (TCRS)

TCRS is a partnership of the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare. The partnership allows molecular and genomic discoveries made by TGen and others around the world to reach the patient bedside in the Virginia G. Piper Cancer Center at Scottsdale Healthcare as quickly as possible through clinical trials with agents directed at specific targets in patients' tumors.

About the Virginia G. Piper Cancer Center at Scottsdale Healthcare

The Virginia G. Piper Cancer Center at Scottsdale Healthcare offers research, diagnosis, treatment, prevention and support in its facilities on the campus of Scottsdale Healthcare Shea Medical Center, attracting patients from across Arizona and the U.S. Groundbreaking cancer research is conducted through its Scottsdale Healthcare Research Institute and TGen Clinical Research Services (TCRS), which provide targeted patient-specific therapies and support additional research activities through Scottsdale Healthcare. For more information, visit www.shc.org.

About TGen Drug Development (TD2)

TD2 is a wholly owned subsidiary of the Translational Genomics Research Institute (TGen) and is a 501(c)3 non-profit organization. TD2 provides innovative services for oncology-focused biopharmaceutical companies utilizing a dedicated team of professionals with broad experience and understanding in drug development. TD2 is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCE's) for life-threatening diseases. TD2 utilizes a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and non-proprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process. www.td2.org

About TGen

The Translational Genomics Research Institute (TGen) is a non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

About Caris Diagnostics (Caris Dx)

Caris Dx is a U.S.-based biosciences company specializing in the development and commercialization of clinically-validated molecular diagnostics and anatomic pathology services primarily in the fields of oncology, dermatopathology, hematopathology and gastrointestinal pathology. The company provides academic-caliber medical consults through its industry-leading team of subspecialty fellowships and expert-trained pathologists in gastrointestinal and liver pathology, dermatopathology and hematopathology. Caris Dx also offers advanced molecular analyses of patient samples through prognostic testing services and genomic and proteomic profiling to assist physicians in their treatment of cancer and other complex diseases. Currently, Caris Dx receives and analyzes biopsies for more than 2,700 patients per day, referred by more than 2,500 physicians nationally. Formed in 1996, the company is headquartered in Irving, Texas and operates four laboratories: Irving, Texas; Phoenix, Arizona (2 sites) and Newton, Massachusetts. Additional information is available at www.carisdx.com.

Fairfax Northern Virginia Hematology Oncology

For more than 30 years, Fairfax Northern Virginia Hematology Oncology (FNVHO), based in Fairfax, Va., has contributed greatly to the campaign against cancer and diseases of the blood by offering advancements in technology, treatment, early detection and clinical trials. For residents throughout Northern Virginia this means the chances of beating cancer are better than ever. Illustrating the outpatient emphasis of cancer treatment, FNVHO's cancer care and blood disorder specialists work closely with you and your family to create an individual treatment plan that provides for your physical and emotional health, all in the familiar setting of your community. www.fnvho.com.

About George Mason University's Center for Applied Proteomics and Molecular Medicine

The Center for Applied Proteomics and Molecular Medicine in Manassas, Va., is a key element of the Life Sciences initiative in the College of Science. Proteomics -- the study of proteins, how they communicate and interact, and how those actions impact biology -- is the new frontier in molecular medicine. CAPMM Scientists, have invented the RPMA technology to provide the unprecedented ability to measure the activity level of hundreds of protein pathway biomarkers at once from a tiny needle biopsy. These biomarkers can then be used to directly tailor treatment based on the unique patient-specific information within the tumor itself. The new classes of molecular targeted inhibitors that are just now reaching the bedside act by modulating protein activity, not genes and the RPMA technology was developed by the CAPMM to synergize with these new compounds. Working with clinical investigators from health care partners and industry collaborators, their goal is to accelerate innovative laboratory discoveries into clinical research at the bedside, which holds the promise of individually tailored therapies and personalized disease management for patients, and the discovery of biomarkers for early disease detection.

About the Side-Out Foundation

The Side-Out Foundation (Side-Out) was established in 2004 by a group of individuals drawn together by their love of volleyball, but who also share a similar passion to be a part of the war against breast cancer. Side-Out's mission is to raise money for the war against breast cancer through the sport of volleyball. www.side-out.org

SOURCE Scottsdale Healthcare