Cleveland Clinic Launches Breast Cancer Vaccine Trial

Triple-negative breast cancer (TNBC) is notoriously difficult to treat, as it lacks estrogen and progesterone receptors and excess HER2 protein. Without these characteristics, therapies used to treat other forms of the disease are not effective. A new trial is attempting to work around this by preventing the formation of TNBC altogether.

The Cleveland Clinic is launching a vaccine trial involving patients who recently completed treatment for early stage TNBC and are at high risk for recurrence. The vaccine will focus on a lactation protein called alpha-lactalbumin, which is not found in healthy breasts once lactation has ceased. However, it is found in most cases of TNBC. The goal is to activate an immune response that will provide protection against breast tumors expressing alpha-lactalbumin. In mouse models, this type of activation was safe and effective in preventing tumor formation.


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

Between 18 and 24 participants will receive differing doses of the vaccine to gauge side effects and immune response. There will be three vaccinations administered, each two weeks apart. With the phase 1 trial, researchers hope to determine which dose should be used in subsequent studies. Going forward, they’d like more advanced trials, including those involving healthy women at high risk of developing breast cancer who have had double mastectomies as a preventative measure.

Dr. G. Thomas Budd, the study’s principal investigator, says, “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.”


If it’s effective, it will be great news in the fight against TNBC, which tends to be more aggressive, higher grade, and more likely to recur. It’s also much more common among Black women and often strikes at a younger age. In addition, about 70% of breast cancers diagnosed in people with an inherited BRCA mutation are triple-negative.

Researchers hope their work can ultimately be applied further than just TNBC, however.

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Dr. Tuohy says, “This vaccine strategy has the potential to be applied to other tumor types. 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.”

This first trial is expected to be completed in September 2022.


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