Traditionally, the testing of potential drugs has been limited to laboratory research and animal testing.
The American Clinic in Cleveland, Ohio, announced the start of unprecedented clinical trials for a drug to prevent the development of triple-negative breast cancer (TNBC) – the most aggressive form of this oncological disease, which is particularly difficult to treat.
According to statistics, this form of breast cancer is most commonly diagnosed in young women under the age of 40 and in people with an inherited genetic mutation that significantly increases the risk of developing the disease (BRCA1).
Among breast cancer patients, it accounts for approximately one in six or seven cases.
Approximately one quarter of patients die within five years of being diagnosed with TNRMZH.
Actress Angelina Jolie inherited this mutation from her maternal ancestors.
After learning that she had an 87% chance of developing this type of cancer, the movie star decided to have both of her breasts removed as a preventative measure.
After the surgery, the actress’ risk of developing the disease dropped to less than 5%.
The development of a vaccine that could prevent or at least significantly reduce the risk of developing triple-negative breast cancer has been attempted by several scientific teams for many years.
However, the testing of potential drugs has been limited to laboratory research and animal studies.
On Tuesday, it was announced that the U.S. Food and Drug Administration (FDA) has approved the Cleveland Clinic’s application to conduct human clinical trials of a vaccine.
The drug, which is administered in three injections two weeks apart, works by targeting a specific protein called alpha-lactalbumin in the body.
Normally, it is only produced in young mothers during breastfeeding.
At all other times, the presence of this protein in the blood indicates the presence of a potential tumor, and when it is detected, the vaccine signals the immune system.
For now, the vaccine is being tested only in volunteers who were diagnosed with TNRMZH at an early stage and cured with conventional therapy, but who have a high probability of disease recurrence.
The next step will be to test the vaccine in healthy volunteers from the at-risk group, including women with the inherited BRCA1 gene mutation.