Sharp HealthCare is part of a clinical trial for breast cancer treatment that is showing so much promise in reducing tumors that the U.S. Food and Drug Administration (FDA) has deemed the new drug a “breakthrough therapy.”
This designation is granted only to new therapies that show early evidence of working significantly better than existing treatments for a serious disease. It also sets the therapy on a fast track for review and potential approval so that it can get to patients as soon as possible.
The investigational therapy treats women with a particular type of advanced, aggressive breast cancer. Breast cancer cells in these women have a gene mutation that makes an excess of a protein called HER2 (human epidermal growth factor receptor 2), which promotes the growth of cancer cells.
About 1 in every 5 women with breast cancer has a type that is HER2-positive. Many of these tumors advance to a point where available therapies can no longer control the disease. The cancer often spreads to other parts of the body.
Currently known as DS-8201, the investigational treatment is part of a novel class of drugs called antibody-drug conjugates. It works by attaching chemotherapy to an antibody designed to only bond to cells containing the HER2 protein. Once the drug combination attaches to a breast cancer cell, the chemotherapy is released inside the cell to kill it.
This type of targeted treatment may also reduce the side effects from traditional chemotherapy that can affect both cancerous and noncancerous cells.
“This is a very promising therapy for patients with this type of breast cancer,” says Dr. Charles Redfern, a medical oncologist at Sharp Memorial Hospital, who, along with his colleague, medical oncologist Dr. Jennifer Fisher, co-authored a recent paper on preliminary results from the clinical trial. “We’re excited about the possibilities for this therapy.”
Sharp HealthCare is the only health system in the western part of the United States participating in phase 1 of the clinical trial. Patients have travelled from as far away as Canada to participate in the study at Sharp, says Dr. Redfern.
Larger-scale phase 2 trials are expected to start soon to better understand the effectiveness of this investigational treatment.
For the news media: To talk with Dr. Charles Redfern about breast cancer clinical trials at Sharp HealthCare for an upcoming story, contact Erica Carlson, senior public relations specialist, at firstname.lastname@example.org.