Cleveland Clinic Launches Breast Cancer Vaccine Study

CLEVELAND — A new study will examine if a vaccine can prevent triple-negative breast cancer, the deadliest form of the disease.

The study is being conducted by the Cleveland Clinic, with partner Anixa Biosciences. The first phase will determine how much vaccine a person's body can tolerate when they are also dealing with early-stage triple-negative 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 Dr. G. Thomas Budd, of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study.

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Triple-negative breast cancer does not respond to hormonal or targeted therapies, the Cleveland Clinic said. While triple-negative only accounts for approximately 13 percent of all breast cancer cases, it represents a much-higher total of breast cancer deaths and recurrences.

“This vaccine approach represents a potential new way to control breast cancer,” said Dr. Vincent Tuohy, the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute.

The upcoming Cleveland Clinic study will include 18 to 24 patients. The patients must currently be tumor free but at high-risk of recurrence. During the study, participants will get three vaccinations, with two weeks between each shot. The patients will then be monitored for their response and for any side effects.

The study should be completed in September 2022.

If subsequent trials are approved, they would include cancer-free women who are at high-risk of developing breast cancer and have decided to undergo voluntary bilateral mastectomy to lower their risk, the Cleveland Clinic said.

“This vaccine strategy has the potential to be applied to other tumor types,” Tuohy said. “Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. 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.”