After the Cleveland Clinic announced last Tuesday the launch of a groundbreaking human trial to test a dose designed to prevent triple-negative breast cancer, which currently does not respond to hormonal or targeted drug therapies and can only be prevented through mastectomy, signs have emerged indicating that a promising vaccine may bring hope. So far, developments in vaccines for triple-negative breast cancer have been limited to laboratory work and animal research, but the human trial can now begin following the approval of a new experimental drug by the U.S. Food and Drug Administration.
Despite the trial initially involving only early-stage triple-negative breast cancer survivors who are at high risk for recurrence, researchers hope to subsequently apply the vaccine to healthy individuals at risk of developing the disease, such as those with genetic mutations in the BRCA1 gene. Dr. J. Thomas Byrd from the Taussig Cancer Institute at the Cleveland Clinic and the principal investigator of the study stated in a press release that, over the long term, there is hope this could become a true preventive vaccine given to women to prevent them from developing triple-negative breast cancer.
It is worth noting that the disease is usually associated with a specific protein, α-lactalbumin, which is supposed to appear only during breastfeeding. The vaccine will target this protein, prompting the immune system to fend off emerging breast tumors that express it. The injection will also include a drug that alerts the immune system to lactalbumin so it can halt the growth of newly formed tumors.
The trial will involve 18 to 24 patients free of tumors after treatment for early-stage breast cancer within the past three years. They will receive three doses, each administered two weeks apart. Researchers will start with low doses in a few patients and monitor them closely before increasing the dosage and including more participants. Byrd stated, "Once we determine how much vaccine we can administer, we will look at its effects on the immune system. This will help us understand whether the vaccine does what we want, and then we will scale up the level of each dose."
The study is expected to be completed by September 2022 and is funded by the U.S. Department of Defense. It is noted that triple-negative breast cancer accounts for about 12% to 15% of all breast cancers and kills nearly a quarter of patients within five years of diagnosis. It is more common among African American women and those with BRCA1 mutations.
