First Human Vaccine Trial to Prevent Triple Negative Breast Cancer Begins

For the first time, a vaccine designed to prevent triple negative breast cancer is being studied in humans. The researchers explain this early phase clinical trial.

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CLEVELAND – For the first time, a vaccine designed to prevent triple negative breast cancer is being studied in humans.

About 15% of breast cancers are triple negative – the most aggressive form.

Cleveland Clinic doctors have now vaccinated the first study participants in this phase one clinical trial.

“The main goals are two. One, to determine the side effects and safety of the vaccine and two, to determine whether it produces an immunological response,” said G. Thomas Budd, MD, of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study. “Because this is a vaccine we’re depending on the body mounting an immune response and we’ll be monitoring that immune response with blood tests.”

Up to 24 women will be enrolled in the study, which is funded by the U.S Department of Defense.

Participants will have been diagnosed with early stage triple negative breast cancer within the last three years and are tumor-free but at risk for recurrence.

The vaccine targets a lactation protein called ?-lactalbumin, which is expressed in the majority of triple negative breast cancers.

If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and keep it from growing. The vaccine is administered in three doses, given two weeks apart.

While this initial trial will study women who have already been diagnosed with triple negative breast cancer, the ultimate goal is to prevent the disease from developing in the first place.
“What we’re trying to do is what we call primary prevention. It’s actually preventing the disease from occurring to begin with – it was never there to begin with. We’re not trying to prevent recurrence. We’re trying to prevent the emergence of the tumor and prevent it from ever happening,” said Vincent Tuohy, Ph.D., the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute.
The research team has been working on developing this vaccine for nearly 20 years. It could take 10 years or more before the vaccine is available to the general population, and only if results are favorable.

The researchers hope, one day, their work will pave the way for a vaccine to prevent all forms of breast cancer.

Editor’s Note: Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences, Inc. He will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and also holds personal equity in the company.

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