Cleveland Clinic is moving forward with its triple-negative breast cancer vaccine in a 1b trial.
Triple-negative breast cancer is one of the most aggressive and deadly, and does not respond well to current treatment methods, according to a Feb. 8 clinic press release.
The new study includes 6 to 12 cancer-free patients who are at high risk for developing breast cancer and already underwent voluntary prophylactic mastectomy to lower their risk. Patients will receive three vaccines given two weeks apart and will be closely monitored for immune response and side effects. The 1b study will wrap up by the end of the year.
"Triple-negative breast cancer is the form of the disease for which we have the least effective treatments," G. Thomas Budd, MD, of Cleveland Clinic's Taussig Cancer Institute and principal investigator of the study, said in the release. "Long term, we are hoping that this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease."
The 1b clinical trial follows the ongoing phase 1a study, which will also be completed by the end of the year. The phase 1a trial includes patients who completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk of recurrence.