Cleveland Clinic has started a phase I trial involving an investigational vaccine aimed at preventing triple-negative breast cancer, the health system said Oct. 26.
The trial, designed to determine the maximum tolerated dose of the vaccine, will enroll 18 to 24 patients who have completed treatment for early stage triple-negative breast cancer — the most aggressive form of the disease — within the last three years. Participants must be tumor-free at the time of enrollment and considered at high risk for recurrence. The study is expected to be completed in September 2022.
Researchers anticipate subsequent trials will enroll healthy, cancer-free women to evaluate whether the vaccine can prevent high-risk patients from developing this type of breast cancer.
"We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer," said G. Thomas Budd, MD, the study's principal investigator and physician at Cleveland Clinic's Taussig Cancer Center. "Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments."
The vaccine targets α-lactalbumin, a breast-specific lactation protein that is not found in normal, aging tissues post-lactation, but is present in the majority of triple-negative breast cancer.
The trial is based on preclinical research that indicated activating the immune system against
α-lactalbumin was safe and effective in preventing breast tumors in mice. That research, led by Vincent Tuohy, PhD, primary inventor of the vaccine and staff immunologist at Cleveland Clinic's Lerner Research Institute, also found a single dose could prevent breast tumors from occurring in mouse models and halt the growth of already existing breast tumors.
The trial is being led in partnership with Anixa Biosciences, which has an exclusive license over the vaccine technology.