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Our mission is to support research efforts to achieve the primary prevention
of breast and ovarian cancers. The focus of our efforts is to obtain
federal funding for a “Women’s Health Initiative” to facilitate
clinical trials for the primary immune prevention
of breast and ovarian cancer in otherwise healthy, cancer-free women.
Call the Cleveland Clinic Cancer Answer Line: (866) 223-8100, or Dr. Amit Kumar at Anixa Biosciences 408-708-9802
Phase I Breast Cancer Vaccine Trial at
Cleveland Clinic Trial Status:
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What is it?---Cleveland Clinic is conducting a Phase I clinical trial of a novel breast cancer vaccine, intended to prevent triple-negative breast cancer (TNBC). The purpose of the Phase I trial is to evaluate safety and optimize dosing, and measure biomarkers indicating efficacy.
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How does it work?---This vaccine was invented by the late Vincent K. Tuohy, PhD. The vaccine induces the immune system to destroy cancer cells based on targeting a protein that is only produced during lactation and cancer cell formation of many types of breast cancer including TNBC.
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Who is eligible?---The Phase I trial includes 3 cohorts, which are all currently open to recruitment:
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Phase Ia subjects have been treated for TNBC and are in remission with a high risk of recurrence.
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Phase Ib subjects have never had breast cancer but are planning a risk-reducing mastectomy due to high genetic and/or familial risk.
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Phase Ic subjects have the same requirements as Phase Ia, but are being treated with pembrolizumab (Keytrudaä), a powerful newly approve immunotherapy.
What are the results so far?---Data so far have shown that the majority of subjects have developed a substantial cellular immune response against the target protein, alpha-lactalbumin. The side effects at the current doses have been generally mild, consisting mainly of injection site inflammation and irritation.
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What are the future plans?---Phase I is expected to be completed in October of 2024. A Phase II follow-up study to evaluate the efficacy of the vaccine is actively being planned by Cleveland Clinic and Anixa Biosciences, a Silicon Valley Biotech company.
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Who is funding the trial?--Funding for Phase I has been generously provided by the U.S. Department of Defense, awards W81XWH-17-1-0592 and W81XWH-17-1-0593.
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Why do we need support?---Our current funding only supports a Phase I clinical trial. To conduct Phase II/III trials, we will require additional sources of funding.
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What impact could the breast cancer vaccine have?---If it is shown to be effective in subsequent clinical trials, the alpha-lactalbumin vaccine may help prevent the most lethal form of breast cancer and perhaps other breast cancers. The success of this vaccine will also change the R&D paradigm for how to prevent cancer. This would have a major impact on patients and the whole cancer landscape. Together with the National Cancer Institute and Anixa Biosciences, we are also developing a similar Ovarian Cancer Vaccine.
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Where can I get more information?---For more information on the trial on, visit https://clinicaltrials.gov/search?term=NCT04674306 or call the Cleveland Clinic Cancer Answer Line: (866) 223-8100, or Dr. Amit Kumar at Anixa Biosciences 408-708-9802