Approximately 40 patients will enroll in this National Cancer Institute-sponsored phase 2 study nationwide.
Triple negative breast cancers represent 15-20 percent of the more than 211,000 women diagnosed with breast cancer annually in the United States. These breast cancers are often more aggressive, occur in younger women and have limited treatment options.
In this Ohio State-led trial, breast medical oncologist and principal investigator Erin Macrae, MD, will test two new experimental drugs, given in combination, that target specific tumor proteins involved cancer growth and survival.
An experimental agent—known presently as GSK2141795—is given in combination with the drug trametinib to simultaneously target two distinct pathways thought to interact to cause cell growth and enable cells to become cancerous. Trametinib is approved by the Food and Drug Administration for treating patients with BRAF-mutated metastatic melanoma. The use of trametinib in breast cancer is considered experimental.
“By blocking two cancer-promoting signaling pathways simultaneously, you have the potential to stop a cancer’s ability to become resistant to treatment,” explains Macrae. “Metastatic triple negative breast cancer is incurable by standard chemotherapy and represents an area of unmet clinical need for which development of new targeted drugs are being pursued. We hope that this clinical trial will show that this drug combination will decrease tumor growth in these patients.”
The trial is currently open to patient enrollment at The OSUCCC – James. Additional sites are under consideration to also open the study, including the Cleveland Clinic, Georgetown, Moffitt, Roswell Park, University Hospitals/Case Western, University of North Carolina, Vanderbilt and Virginia Commonwealth.
Patients with metastatic triple negative breast cancer may qualify for this study. For more information, call The James Line at 1-800-293-5066.
Macrae is part of a 20-plus physician team at the OSUCCC-James dedicated exclusively to the treatment of breast cancer. The team is housed at the Stefanie Spielman Comprehensive Breast Center and includes medical oncologists, surgical oncologists, radiologists, radiation oncologists, geneticists and reconstructive surgeons as well as psychologists, physical therapists, social workers, dieticians and oncology-trained nurses.
About The OSUCCC – James
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute strives to create a cancer-free world by integrating scientific research with excellence in education and patient-centered care, a strategy that leads to better methods of prevention, detection and treatment. Ohio State is one of only 41 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only four centers funded by the NCI to conduct both phase I and phase II clinical trials. The NCI recently rated Ohio State’s cancer program as “exceptional,” the highest rating given by NCI survey teams. As the cancer program’s 228-bed adult patient-care component, The James is a “Top Hospital” as named by the Leapfrog Group and one of the top cancer hospitals in the nation as ranked by U.S.News & World Report.
Contact: Amanda J. Harper, Director of Media Relations, OSUCCC – James, 614-293-3737 (media line), 614-685-5420 (direct) or [email protected]