Cleveland Clinic presents first phase findings of breast cancer vaccine clinical trials
The Cleveland Clinic presented its findings of the first phase of a clinical trial for a potential breast cancer vaccine on December 11, 2025.
The proposed vaccine is aimed at preventing triple-negative breast cancer (TNBC).
This specific type of breast cancer is known to the Cleveland Clinic as a rare type of invasive breast cancer that affects about 13 in 100,000 women in the United States.
Results from the study team show that the investigational vaccine produced an immune response in the majority of participants, totaling 74%.
Dr. Thomas Budd of the Cleveland Clinic's Cancer Institute, the principal investigator of the study, says that although patients exhibited an immune response, it's unclear if the vaccine would prevent breast cancer at this time.
"Whether this immune response will translate into reducing the risk of recurrence or preventing breast cancer, reducing the risk of breast cancer, we don't know that yet from this trial," said Dr. Budd.
Phase Two of the project is expected to begin in late 2026 and could last approximately two to three years. Those trials, Dr. Budd says, would be the first look at the vaccine effectiveness.
"Does it reduce the risk of the cancer coming back in patients who have breast cancer, and in future trials, perhaps, be able to look at whether it can prevent breast cancer in patients who have very high risk for it," said Dr. Budd.
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