Study to Investigate Potential Vaccine Against Triple-Negative Breast Cancer

TNBC is the most aggressive and lethal form of the disease.

A novel study for a vaccine intended to prevent triple-negative breast cancer (TNBC) has been launched by investigators at the Cleveland Clinic. TNBC is the most aggressive and lethal form of the disease.

The phase 1 trial is designed to determine the maximum tolerated dose of the vaccine in patients with early-stage TNBC. Further, investigators intend to characterize and optimize the body’s immune response.

“We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” said G. Thomas Budd, MD, of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study, in a press release. “Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments.”

TNBC has no biological characteristics that typically respond to hormonal or targeted therapies. Although it only accounts for 12% to 15% of all breast cancers, TNBC results in a disproportionately higher percentage of deaths than other forms of breast cancer and has a higher rate of recurrence.

The investigational vaccine functions by targeting alpha-lactalbumin, a breast-specific lactation protein. In normal aging tissues, this protein is no longer found post-lactation; however, it is present in the majority of TNBC cases. Priming the immune system to respond to this protein could provide protection against tumors that express it.

“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, PhD, the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute, in the release. “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.”

The trial will enroll 18 to 24 patients who have completed treatment for early-stage TNBC and who are currently tumor-free but are at high risk of recurrence. Participants will receive 3 vaccinations, each 2 weeks apart, and will be closely monitored for adverse effects and immune response. It is estimated to be completed in September 2022.

“This vaccine strategy has the potential to be applied to other tumor types,” Tuohy said in the release. “Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had.”


Cleveland Clinic launches first-of-its kind preventive breast cancer vaccine study [news release]. EurekAlert; October 26, 2021. Accessed October 27, 2021.

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