Clinical Trial Launched for Preventive Breast Cancer Vaccine

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Cleveland Clinic’s Lerner Research Institute has initiated a new study to examine a vaccine to prevent triple-negative breast cancer.

Cleveland Clinic announced this week that it has opened a phase 1 trial to examine a new vaccine to prevent triple-negative breast cancer.

Researchers at the Lerner Research Institute will use the trial to figure out what the maximum tolerated dose of the vaccine is in patients with early-stage triple-negative breast cancer (TNBC).

“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 lead study investigator Dr. G. Thomas Budd of Cleveland Clinic’s Taussig Cancer Institute in a release.

The Food and Drug Administration (FDA) recently approved an investigational new drug application for the vaccine, enabling the researchers at Cleveland Clinic and partner Anixa Biosciences, Inc. to initiate the study.

Although TNBC is a less common form of breast cancer, new treatment methods are much needed, as it accounts for a higher percentage of deaths and recurrences. It is also been shown to disproportionately affect African American women.

Pre-clinical research, which showed the vaccine’s safety in mice, was led by Vincent Tuohy, the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute. The vaccine works by targeting α-lactalbumin, a breast-specific lactation protein that is present in the majority of TNBC cases. By activating the immune system against this protein, the vaccine provides protection/prevention of future tumors expressing α-lactalbumin.

The trial will study the effect of the vaccine in 18-24 patients with TNBC who received treatment within the past three years and are tumor-free with high-risk of recurrence. They will receive three vaccinations spaced two weeks apart, and the trial will be completed by Sept. 2022.

“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.”

A follow-up trial is also anticipated, in which researchers will potentially study cancer-free women who are at high-risk of breast cancer and have decided to undergo a bilateral mastectomy.

“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.”

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