Cleveland Clinic announces next step in breast cancer vaccine

CLEVELAND (WJW) – Cleveland Clinic researchers have launched the next step in their study of a breast-cancer preventative vaccine. 

This new vaccine is aimed at preventing triple-negative breast cancer, the most aggressive and lethal form of the disease, according to a press release from 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.”

The new phase 1b study will enroll cancer-free people at high risk for developing breast cancer who have decided to voluntarily undergo a prophylactic mastectomy to lower their risk. 

This category of people typically carry genetic mutations that put them at risk of developing triple-negative breast cancer or have a high familial risk for any breast cancer, the release said.

The phase 1b clinical trial follows the ongoing phase 1a study, which opened in 2021 and is expected to be complete by the end of 2023.

The phase 1a trial includes 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.

The study, conducted at Cleveland Clinic’s main campus, will evaluate the safety of the vaccine and monitor immune response, the release said.

The new study will include about six to 12 patients and is set to be completed by the end of 2023.

This Cleveland Clinic study is funded by the U.S. Department of Defense and conducted in partnership with Anixa Biosciences, Inc.

According to Dr. Budd, there is a great need for improved treatments for triple-negative breast cancer, which does not have biological characteristics that typically respond to hormonal or targeted therapies.

Despite representing only about 12% to 15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths. It is twice as likely to occur in Black women, and approximately 70 to 80% of the breast tumors that occur in women with mutations in the BRCA1 gene are triple-negative breast cancer, according to the release.

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