CLEVELAND, Ohio -- By the end of the month, the Ohio State University James Cancer Hospital will open a Phase 2 clinical trial to test two drugs for the treatment of triple negative breast cancer -- a very aggressive type of cancer with high rates of recurrence.
The trial, developed and led by oncologist Dr. Erin Macrae, will test two drugs that are taken together. Earlier this year the U.S. Food and Drug Administration approved one of the drugs, trafetinib, for the treatment of advanced melanoma. The other drug is a study drug. Both were developed by drug manufacturer GlaxoSmithKline.
An earlier Phase 1 trial at another cancer center has already established that the drugs are safe to use in humans. This new trial is studying to see what effects, if any, the drugs have on patients and their cancer.
"There is no 'routine' triple negative disease," said Macrae, an oncologist at OSU's Stephanie Spielman Comprehensive Breast Center and a graduate of the Case Western Reserve University School of Medicine. "With other [breast cancer types] we can give targeted therapy. We can't with this one."
Triple negative breast cancer, which accounts for 15 to 20 percent of breast cancers, is so hard to treat because it doesn’t have any of the receptors (substances found inside cells that give rise to cancer) that existing drugs are able to fight. Triple negative gets its name from its lack of three hormone receptors -- estrogen, progesterone and HER2.
Researchers hope the two drugs being studied are effective targeted therapies.
“This is one of the most exciting scientific approaches that we have moved forward with in patients with triple negative breast cancer,” said Macrae, who will serve as the primary investigator for the entire trial.
Many other cancer centers have expressed interest in offering the trial to their patients, she said.
Up to 40 patients will be enrolled in the trial. Along with OSU, eight other sites across the country – including the Cleveland Clinic Taussig Cancer Institute and University Hospitals Seidman Cancer Center – will offer the trial.
The trial is sponsored by the National Cancer Institute. For information on this or other cancer clinical trials, people can call OSU at 614-293-4376; the Clinic at 866-223-8100; or UH at 800-641-2422.