TGen-TD2-Scottsdale Healthcare breast cancer pilot study shows value of molecular profiling and proteomic mapping
Patients benefit from treatments tailored specifically for their tumor types; stage set for larger study
SCOTTSDALE, Ariz. — July 17, 2013 — The Side-Out Foundation’s breast cancer pilot study, led by the Translational Genomics Research Institute (TGen), Translational Drug Development (TD2) and Scottsdale Healthcare, has shown that cancer patients do better when their treatment is guided by molecular profiling.
Specifically, 52 percent of patients with advanced breast cancer received clinical benefit — meaning their disease was controlled for a longer time — when their cancer was treated based on addressing the abnormal proteins in their tumor, according to the study conducted at the Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.
Each patient’s treatment was “personalized,” meaning that the therapy they received was based on their individual tumor biology.
“This study demonstrates the feasibility of personalized cancer treatment, and shows that this approach merits further investigation in future studies,” said Gayle Jameson, Nurse Practitioner at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and the study’s Principal Investigator.
“The success of this pilot study will lead to a larger study and hopefully greater clinical benefit for more patients with advanced breast cancer,” said Jameson, who presented the results of the study in June at the 2013 American Society of Clinical Oncology (ASCO) in Chicago.
Due to the overwhelmingly positive results, a new study incorporating additional technology for tumor analysis, Side-Out II, will open at the Virginia G. Piper Cancer Center Clinical Trials in the near future for patients with advanced breast cancer.
“The success of our pilot proof-of-concept study has established a firm launching pad for the upcoming Side-Out II study, which involves a more in-depth investigation of tumor biology with an expanded repertoire of tests to direct personalized treatment,” said Dr. Jasgit Sachdev, M.D., a breast cancer specialist and Associate Professor at the Virginia G. Piper Cancer Center Clinical Trials.
“By showing the significant advantages of molecular profiling, this pilot study has enabled us to move forward with a project that should strengthen the evidence for using this approach in routine clinical care.”
The recent pilot study built on previous studies by Scottsdale Healthcare and TGen that showed the value of guiding treatment based on molecular profiling, in which each patient’s tumor was analyzed for protein abnormalities that may “drive” the cancer’s growth. The results pointed investigators toward specific genetic changes that might be addressed by specific medications.
Beyond molecular profiling, the pilot study also included mapping proteomic pathways within the tumor tissue so each patient could receive a highly targeted regimen designed to impede their cancer growth.
All of the patients in the recent study had advanced breast cancer that had progressed following multiple previous chemotherapy treatments. Of the 25 patients, 13 received clinical benefit as a result of molecular profiling. For all 25 patients, the therapy selected based on their tumor analysis was different than what they would have received in their next planned treatment, if they had not participated in the study.
The Virginia G. Piper Cancer Center at Scottsdale Healthcare was the lead site in the 2-½ year pilot study. In addition, patients in the study were treated at Virginia Cancer Specialists, US Oncology, in Fairfax, Vir.; and at Evergreen Hematology & Oncology in Spokane, Wash.
Translational Drug Development (TD2), a TGen company, managed the pilot clinical trial, and will also oversee the follow-on study, Side-Out II.
“This was an exciting study for TD2,” said Linda Vocila, BSN, RN, Director of Clinical Operations at TD2 and co-author of the study. “It demonstrates that close collaboration between physicians and scientists leads to greater clinical benefit for patients with cancer.”
Two labs analyzed tissue: the Center for Applied Proteomics and Molecular Medicine (CAPMM) at George Mason University in Manassas, Vir.; and Caris Life Sciences in Phoenix.
The Side-Out Foundation of Fairfax, Vir., sponsored the study.
To participate in a clinical trial at the Virginia G. Piper Cancer Center, please contact Patient Care Coordinator Joyce Schaffer at 480-323-1339 or firstname.lastname@example.org.
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Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with cancer, neurological disorders and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.
TGen Senior Science Writer
About Translational Drug Development (TD2)
Translational Drug Development (TD2) is an oncology drug development organization and is wholly owned by the Translational Genomics Research Institute (TGen). TD2 provides innovative services for oncology focused biopharmaceutical companies using 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 uses 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. For more information about Translational Drug Development, visit www.td2inc.com.
VP, Business Operations
About the Virginia G. Piper Cancer Center at Scottsdale Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Ariz. offers comprehensive cancer treatment and research through clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading scientific researchers and community oncologists. Scottsdale Healthcare is the nonprofit parent organization of the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale Healthcare Research Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital. For more information, visit www.shc.org.
Virginia G. Piper Cancer Center at Scottsdale Healthcare
About Caris Life Sciences
Caris Life Sciences 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 Life Sciences 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. Additional information is available at www.carislifesciences.com.
About Evergreen Hematology & Oncology
Evergreen Hematology & Oncology is a group of physicians, nurses, and support staff committed to offering a new approach to treating cancer in an environment that provides the utmost in hospitality and caring – as well as the very latest in cutting-edge cancer treatments.
We believe we have both a moral and an ethical obligation to participate in the search for a cure. We believe our patients should have access to all options available to successfully meet the challenges of cancer. And we believe that, whether you’re newly diagnosed or coping with recurrence, you deserve more than just treatment. You deserve the best in front-line therapy. You deserve hope. More information: evergreen4cure.com
About Virginia Cancer Specialists
For more than thirty years, Virginia Cancer Specialists 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, Virginia Cancer Specialists cancer care and blood disorder experts 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. virginiacancerspecialists.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.
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.