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On the heels of Breast Cancer Awareness month, it is certainly timely to hear of a new breast cancer vaccine trial that is underway. 

Statistics indicate that approximately 1 in 8 women will receive an invasive breast cancer diagnosis at some point in their lifetime. Of those women, some will battle the most deadly form of this disease — triple-negative breast cancer. The treatments for this type of cancer currently have the least effective options. 

For that reason, experts at the Cleveland Clinic are focused on improving outcomes for women facing this particularly aggressive disease. A phase 1 clinical trial has begun with a goal of developing an effective vaccine that will help with prevention. Albeit they anticipate it could take decades for the vaccine to get developed, approved, and launched into market, researchers are hopeful their efforts will materialize. 

This study is comprised of women who have recently completed treatment for early-stage triple negative breast cancer. Part of the participation criteria includes that they are not nursing and will also not become pregnant. Lastly, those involved in the study have no signs of disease, but are still considered high risk for the cancer to return. 

The small group of people in the trial,18-24 participants, will be given assorted doses of the vaccine; this strategy will help researchers understand any side effects, and determine if it produces the expected immunologic response. The women will receive a total of three vaccine shots and each dose will be administered two weeks apart. 

Dr. G. Thomas Budd, an oncologist at the Cleveland Clinic, is the principal investigator of the study. Budd said, “What we hope to do is, first, show that we can mount an immune response against one protein that is expressed in the majority of triple-negative breast cancer.” 

He continued, “And if we can, we might be able to vaccinate patients or people who are at risk to develop breast cancer, and then prevent them from getting it in the first place — that’s the long-term goal.” 

The study’s phase 1 goal is to identify which dose should be implemented in future studies. 

“The ultimate goal, ultimately, not of this trial, but future trials, would be to be able to prevent breast cancer, triple-negative breast cancer in those who are at very high risk for it,” Budd explained. “So, initially this would be people with family histories and genetic mutations known to predispose them to triple-negative breast cancer.” 

The Cleveland Clinic’s vaccine targets alpha-lactalbumin, a protein, which is typically produced in lactating breasts. According to experts, there isn’t another time when (normal) human cells create that protein, with the exception of nearly 70% of triple-negative breast cancers. 

Budd wants to be very clear about this study’s timeline expectations. “I think the main thing I do want to just emphasize is this is very, very early in development. It will take really decades to prove what we need to prove because it takes years to develop breast cancer.” 

Vincent Tuohy, the vaccine’s primary inventor and a staff immunologist at Lerner Research Institute said in a press release, “This vaccine approach represents a potential new way to control breast cancer.” Tuohy went onto say, “The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.” 

Triple-negative breast cancer comprises between 10%-15% of women with breast cancer, according to the American Cancer Society. Of that population, Black women, women with the BRCA1 mutation, and women under 40-years-old are the most susceptible. 

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