CLEVELAND — The Cleveland Clinic announced Tuesday that researchers at its Lerner Research Institute have opened a clinical trial for a vaccine aimed to prevent triple-negative breast cancer, one of the most aggressive and lethal forms of the disease.
The investigational vaccine targets a breast-specific lactation protein, a-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers, the clinic said.
The clinic and its partner, Anixa Biosciences, Inc., are now permitted to start the study since the U.S. Food and Drug Administration recently approved an investigational new drug application for the vaccine.
“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, M.D., of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study. “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.”
Despite triple-negative breast cancer representing only about 12 to 15% of all breast cancers, it accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. It’s also twice as likely to affect African-American women. Approximately 70-80% of the breast tumors that occur in women with mutations in the BRAC1 genes are triple-negative breast cancer.
“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, Ph.D., the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute. “The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.”
The research has found that a single vaccination could prevent breast tumors from occurring in mouse models, while also inhibiting the growth of already existing breast tumors.
The study will include 18 to 24 patients who have completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumor-free but remain at high risk. Participants will receive three vaccinations, each two weeks apart and will be monitored for side effects and immune response. The study is estimated to be completed in September 2022.
Researchers at the Clinic anticipate that a subsequent trial will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. Typically these women carry mutations in either the BRCA1 or BRCA2 gene.
“If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had,” said Tuohy.
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