October is Breast Cancer Awareness Month, and for the first time, a vaccine designed to prevent triple negative breast cancer is being studied in people.
Triple negative breast cancer is the most aggressive form. Close to 15 percent of breast cancers are triple negative. Cleveland Clinic just announced the opening of this vaccine study, and its doctors have now vaccinated the first study participants in the phase one clinical trial.
“The main goals are two. One, to determine the side effects and safety of the vaccine, and two, to determine whether it produces an immunological response. Because this is a vaccine, we’re depending on the body mounting an immune response, and we'll be monitoring that immune response with blood tests," Dr. G. Thomas Budd, of Cleveland Clinic's Taussig Cancer Institute and principal investigator of the study, said.
Up to 24 women will be enrolled in the study, which is funded by the Department of Defense. Women getting the vaccine have already been diagnosed with early-stage triple negative breast cancer within the last three years, and don't have any tumors but are at risk for recurrence.
Cleveland Clinic said the vaccine targets a lactation protein called alpha-lactalbumin, which is found in most triple negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and keep it from growing. The vaccine is given in three doses, two weeks apart.
While this initial trial will study women who've already been diagnosed with triple negative breast cancer, the ultimate goal is to prevent the disease from developing in the first place.
"What we're trying to do is what we call primary prevention. It's actually preventing the disease from occurring to begin with. It was never there to begin with. We're not trying to prevent recurrence. We're trying to prevent the emergence of the tumor and prevent it from ever happening," said Dr. Vincent Tuohy, the primary inventor of the vaccine and staff immunologist at Cleveland Clinic's Lerner Research Institute.
The Cleveland Clinic research team has been working on developing this vaccine for nearly twenty years. It could take ten years or more before the vaccine is available to the general population if the study shows it work.
Researchers hope, one day, their work will pave the way for a vaccine to prevent all forms of breast cancer.