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October 27, 2021 – Researchers at the Cleveland Clinic have launched a new study to test a vaccine to prevent triple negative breast cancer, the most aggressive and deadly form of the disease.
The first phase of the clinical test will determine the strength of a vaccine dose that patients with early triple negative breast cancer can tolerate. It will also examine the body’s immune response to the vaccine.
“We hope this research will lead to more advanced trials to determine the vaccine’s effectiveness against this very aggressive type of breast cancer,” said G. Thomas Budd, MD, principal investigator. in a report.
Triple negative breast cancer does not generally respond to hormonal or targeted therapy, the Cleveland Clinic said. It accounts for about 12-15% of all breast cancers, but causes a high percentage of breast cancer-related deaths and has a high rate of recurrence.
The severe form of breast cancer is twice as likely to occur in black women, the clinic said. About 70-80% of breast tumors in women with BRCA1 gene mutations are triple negative breast cancers.
The researchers hope that the vaccine, developed with Anixa Biosciences, will eventually be administered to healthy women to prevent triple negative breast cancer from developing in the first place.
The vaccine targets a breast-specific lactation protein, alpha-lactalbumin, which is not usually found after lactation but is present in most triple-negative breast cancers, the clinic said. The vaccine would activate the immune system against this “reprocessed” protein and provide protection against new tumors with the protein.
The study is based on research which showed that activating the immune system against the protein was safe and effective in preventing breast tumors in mice, the clinic said. Research also found that a single vaccine could prevent the onset of breast tumors and stop the growth of existing tumors. The research, which was originally Posted in Natural medicine in 2010, was funded by philanthropic donations from over 20,000 people over the past 12 years.
The new study at the Cleveland Clinic is funded by the Department of Defense and open to non-clinical patients. The first phase of the trial will include 18 to 24 patients who have completed treatment for early-stage triple-negative breast cancer within the past 3 years and are tumor-free but considered to be at high risk for recurrence.
During the study, participants will receive three vaccinations spaced 2 weeks apart. They will receive varying doses of the vaccine and will be monitored for side effects and immune response, the clinic said.
The researchers believe the study will be completed in September 2022. In a subsequent clinical trial, the vaccine will be tested on cancer-free women at high risk of triple-negative breast cancer. Typically, these women have mutations in the BRCA1 or BRCA2 gene and have a high familial risk of breast cancer.
“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, PhD, lead vaccine inventor and immunologist at the Cleveland Clinic, in the statement.
The vaccines could also be applied to other types of cancerous tumors, he said, although such clinical trials will likely take decades to materialize.
“Our translational research program is focused on developing vaccines that prevent diseases we face with age, such as breast, ovarian and endometrial cancers,” he said. “If successful, these vaccines have the potential to transform the way we control adult cancers and improve life expectancy. “
Details on study eligibility criteria and enrollment are available on ClinicalTrials.gov.
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Sources 2/ https://www.webmd.com/breast-cancer/news/20211027/cleveland-clinic-breast-cancer-vaccine The mention sources can contact us to remove/changing this article |
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