A first-of-its-kind breast cancer vaccine begins phase I trials. The trial will be the first to test a vaccine against triple-negative breast cancer, the most aggressive and deadly form of breast cancer in humans.
“In the long run, we hope this could be a real preventative vaccine that could be administered to healthy women to prevent the development of triple negative breast cancer, the type of breast cancer for which we have the least effective treatments,” said study lead researcher G. Thomas Budd in a statement.
The Cleveland Clinic announced the trial Tuesday after the U.S. Food and Drug Administration approved a new investigational drug application for the vaccine. Based on two decades of laboratory work and animal research, the world’s first human trial will be conducted at Cleveland Clinic’s Lerner Research Institute and will initially involve between 18 and 24 survivors of early-stage triple-negative breast cancer who are at high risk of relapse. The researchers hope that after the success of this first step, the vaccine could be trialled in healthy people at high risk for the disease, such as those with BRCA1 gene mutations.
However, the trial primarily aims to determine the maximum tolerated dose of the vaccine and to identify and optimize the body’s immune response to it.
For this purpose, participants will receive three vaccines, two weeks apart. The trial will start with a low dose in just a few patients, gradually increase to higher doses, and eventually involve more participants. Participants in the study will be monitored for 84 days after the last vaccination to measure possible side effects.
“Once we figure out how much of the vaccine we can give, we’ll look at the effects on the immune system,” Budd told the Cleveland Clinic. “This will help us know if the vaccine is doing what we want it to do, and then we’ll expand each dose level.”
Triple negative breast cancer accounts for 12-15 percent of all breast cancers, but it is the deadliest subtype and about a quarter of patients die within five years. It is also quite difficult to treat with hormone therapy and other targeted drugs are ineffective. The only way to prevent it is mastectomy.
The milk protein lactalbumin (milk albumin), the protein that the vaccine will target, activating the immune system to attack the cells that produce it, and typically only seen when a person is breastfeeding, is normally found in excess in 70 to 80 percent of triple negative breast cancers. The vaccine will also contain a drug that stimulates the immune system to lactalbumin and boosts the body’s immune response.
If testing, expected to end in September 2022, proves the vaccine is effective in doing so, the researchers hope it could improve outcomes for people at risk of breast and other cancers.
The vaccine’s chief inventor, Dr. “This vaccine strategy has the potential to be applied to other tumor types,” says Vincent Tuohy, and continues: “Our translational research program is focused on developing vaccines that prevent age-related diseases such as breast, ovarian, and endometrial cancers. If successful, these vaccines will reduce adult-onset cancers. It has the potential to change the way we control it and increase life expectancy in a similar way that the childhood immunization program has.”
While Dr Budd admits to the Cleveland Clinic that it may take years to get to this point, he remains optimistic: “We have to start somewhere – and we’re really excited to take our first step.”
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