About 80 percent of study participants will be randomized to receive a study drug in addition to chemotherapy before surgery and 20 percent will receive standard care, which is chemotherapy before surgery. "For women with this type of breast cancer, chemotherapy before surgery is already the standard for shrinking tumor size and improving surgical outcomes", says Christina Finlayson, MD, surgical oncologist and director of the Diane O'Connor Thompson Breast Center. The study will run for five years and could eventually test dozens of new drugs.
Doctors will be looking for "pathologic complete response", no sign of tumor in the breast tissue and lymph nodes at the time of surgery, as an indication that the study drug made a difference. A complete pathologic response before surgery indicates that the tumor was successfully treated with the medication.
As each woman completes the study treatment, testing of tissue obtained at surgery and information about her outcomes will help researchers decide which treatment will be offered to the next women to join the trial, which is not typically how cancer drug studies work.
"If the first patients respond well to the drug, it's more likely that subsequent patients will get that drug," Elias says. "After a certain number of patients, we can decide if a drug is a success, a failure or needs further evaluation. We hope we can study three or four drugs every nine months or so, which is about twice as fast as usual. And since the study mechanism will be in place, when we're done testing one drug, we can start studying another drug without creating a whole new trial. That will save years of time and millions of dollars."
The trial data for the first time will be public, which means that breast cancer researchers across the country will have unprecedented information about what the tumors look like before, d
|Contact: Jackie Brinkman|
University of Colorado Denver