Cleveland Clinic launches clinical trial to develop vaccine against breast cancer
Researchers at the Cleveland Clinic have announced they are launching the next phase of a study designed to develop a vaccine to prevent triple-negative breast cancer, the most lethal and aggressive form of the disease.
There are few treatments available for triple-negative tumors, said lead investigator Dr. G. Thomas Budd, of the Clinic’s Taussig Cancer Center. This study aims to develop a vaccine that will prevent the cancer altogether.
“There are a lot of ways this may not work, but… it's one of those journeys of a thousand steps that has to start so we're taking the first steps,” said Budd.
The Clinic says the study, funded by the U.S. Department of Defense, will enroll six to 12 currently cancer-free people who are at high risk for triple-negative breast cancer and have already decided to voluntarily undergo a mastectomy to lower their risk.
People in this category typically have genetic mutations that put them at risk for developing triple-negative breast cancer or high familial risk for any form of breast cancer, according to a Clinic media release.
“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,” said Budd.
Only about 12 to 15% of all breast cancers are triple-negative, according to the media release. But it accounts for a disproportionately higher percentage of deaths. Triple-negative breast cancer is twice as likely to occur in Black women, and 70 to 80% of breast tumors that occur in women with mutations in the BRCA1 gene are triple-negative, according to the Clinic.
The vaccine is based on pre-clinical research led by Vincent Tuohy, a Clinic researcher who discovered that, in mice, he could safely activate the immune system against a lactation protein that is present in the majority of triple-negative breast cancers.
The vaccine in the current study is designed to cue a person’s immune system to attack a tumor and keep it from growing if it does develop.
“This could be a model for this approach in other diseases as well, and also serve as demonstration that a vaccine strategy can be helpful in treating breast cancer, preventing breast cancer or other cancers," Budd said.
The study will be held at the Clinic’s main campus in Cleveland and will evaluate safety and monitor immune response, according to the media release. It is expected to be completed by the end of 2023.