Cleveland Clinic researchers are presenting updated findings from their novel study of a vaccine aimed at preventing triple-negative breast cancer, the most aggressive and lethal form of the disease. The study team found that the investigational vaccine was generally well tolerated and produced an immune response in most patients. The team described the side effects of the vaccine, showed the highest tolerated dose to date, and presented the immunologic effects of the vaccine.
Findings are being presented at the Society for Immunotherapy of Cancer Annual Meeting. Launched in 2021 and funded by the U.S.
Department of Defense, the ongoing clinical trial is evaluating safety and monitoring immune response of the vaccine. The phase 1 study, conducted at Cleveland Clinic's main campus in partnership with Anixa Biosciences, Inc., has included 26 patients to date across three cohorts: Phase 1a - 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.
Phase 1b - individuals who are cancer-free and at high risk for developing breast cancer who have elected to voluntarily have a preventative mastectomy to lower their risk. Primarily, these are women with BRCA1, BRCA2 and PALB2 mutations. Phase 1c - patients with early-stage triple-negative breast cancer who have received preoperative chemoimmunotherapy and surgery, and are being treated with pembrolizumab following surgery.
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