The first human trial of a breast cancer vaccine has come to fruition.
Spearheaded by Cleveland Clinic and Anixa Biosciences Inc., the vaccine is focused on preventing the recurrence of triple-negative breast cancer (TNBC), the most aggressive and lethal form of the disease. These partnering entities agree that this new preventative vaccine could potentially eradicate all breast cancers. As a result, a dose was administered to a woman for the first time in 2021, kicking off the phase 1a study. The study has now reached a new level.
“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” said G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the new study. “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.”
In 2023, the American Cancer Society estimates
that more than 300,590 new cases of invasive breast cancer and 55,720 new cases of ductal carcinoma in situ/stage 0 breast cancer will be diagnosed in women in the United States. There has been a 43% decline in breast cancer deaths over the last three decades, thanks partly to awareness, earlier diagnoses, and more effective treatments. However, there is a persistent mortality gap between Black and white women, with Black women having a 40% higher death rate from breast cancer.Why was the vaccine designed?
According to Healthline, a researcher in the Department of Inflammation and Immunity at the Cleveland Clinic invented the vaccine more than two decades ago. Dr. Vincent Tuohy’s cutting-edge research identified a “precursor” to cancer: a lactation protein called α-lactalbumin (aLA). This protein is essential in regulating lactose production in the milk of pregnant and lactating people. However, when a woman stops lactating, the body no longer makes the protein.
The vaccine targets α-lactalbumin, which is no longer “found after lactation in normal, aging tissues but is present in the majority of triple-negative breast cancers,” according to a press release. If a woman develops breast cancer, the vaccine will trigger the immune system to “attack the tumor and keep it from growing.”
While Black women are less likely to breastfeed after childbirth, the risk of breast cancer is paramount. The American Civil Liberties Union blames the relatively low breastfeeding rate on systemic racism. In addition, Black women are also more likely to learn and adopt using formulas from hospitals.
The phase 1b clinical trial
The phase 1b clinical trial comes after the ongoing phase 1a study, which opened in 2021 and is expected to conclude in the 4th quarter of 2023. The phase 1a trial includes tumor-free patients who are at a high risk of redeveloping breast cancer. They have already undergone early-stage, triple-negative breast cancer treatments within the past three years.
Initially, Tuohy’s research proved that “activating the immune system against α-lactalbumin was safe and effective in preventing breast tumors in mice.” And now, researchers believe the vaccine will be successful on multiple types of cancers without chemotherapy.
Black women, a group historically understudied in cancer research, have had nearly a three-fold increased risk of triple-negative breast cancers. According to the National Cancer Institute, the overall five-year survival rate for this aggressive type of cancer is 77%.
“Despite representing only about 12% to 15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths. It is twice as likely to occur in Black women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 gene are triple-negative breast cancer,” per the Cleveland Clinic.
The Perelman School of Medicine at the University of Pennsylvania analyzed
nearly 200,000 patients who received mammograms between 2006 and 2015 across three U.S. health systems. Black women are statistically more likely to have diabetes, heart disease, and obesity—all risk factors for breast cancer. Young Black women have a higher incidence of aggressive cancers and have doubled the mortality rate of young white women.“Clinical trials are really important because what we do today as standard of care was only a clinical trial a few years ago,” said Dr. Francisco Esteva, chief of breast medical oncology at Northwell Lenox Hill Hospital, per Healthline.
“For someone who has completed all their treatment and has no additional effective treatments available to them, it’s very important to consider clinical trials.”