Cleveland Clinic starts new phase for breast cancer vaccine study

Cleveland Clinic starts new phase for breast cancer vaccine study

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CLEVELAND — Researchers at the Cleveland Clinic launched the next step in a vaccine study aimed at preventing triple-negative breast cancer, described as the most aggressive and lethal form of the disease.


What You Need To Know

  • The research includes volunteers who are currently at high risk for breast cancer
  • The study is funded by U.S. Department of Defense
  • Individuals will receive three vaccinations and will be monitored closely during the process

​The U.S. Department of Defense is funding the new phase, which enrolls cancer-free patients who volunteered to have a prophylactic mastectomy to lower their risk of breast cancer.

According to the Cleveland Clinic, “Individuals in that category typically carry genetic mutations that put them at risk of developing triple-negative breast cancer or have high familial risk for any breast cancer. The study, conducted at Cleveland Clinic’s main campus, will evaluate safety and monitor immune response.”

The study is expected to be completed by the end of 2023 and 6-12 individuals will take part in the research. The volunteers will receive three vaccinations two weeks apart and will be monitored during the time frame.

The previous phase of the trial included patients who completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor free but at high risk for recurrence, according to the Cleveland Clinic.

“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” 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 cancer-free individuals to prevent them from developing this highly aggressive disease.”

According to Budd, triple-negative breast cancer makes up approximately 12-15% of all breast cancers, but has a higher number of breast cancer deaths.

The form of breast cancer is twice as likely to occur in Black women, and about 70-80% of the breast tumors that create in women with mutations in the BRCA1 gene are triple-negative breast cancer.

More information and eligibility requirements can be found at ClinicalTrials.gov.

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