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It could be closer than you think.

A team of Cleveland Clinic researchers led by Vincent Tuohy, PhD, recently made discoveries toward what could become the first-ever vaccine to prevent breast cancer.

It works in the lab. Now, we need to see if it works in women.

"We envision a future in which we control breast cancer by preventing it in the same way we prevent childhood infectious diseases — by targeted vaccination that directs a woman’s own immune system to protect herself from developing breast cancer," says Dr. Tuohy.

The research team is poised to take this discovery from the lab to clinical trial in this decade. Your gift today could help jump-start human trials.



Dr. Tuohy participated in a live webchat on March 28, 2011 12 pm (EST)

In the News

What is a preventative breast cancer vaccine?

Researchers at Cleveland Clinic's Lerner Research Institute found that a single vaccination could prevent breast tumors from occurring in mice genetically bred to develop breast cancer, while also inhibiting the growth of already existing breast tumors. The research was orginally published in Nature Magazine in 2010.

What is Shield Biotech?

Cleveland Clinic Innovations has created a spin-off company to develop a preventive breast cancer vaccine based on research from Cleveland Clinic's Lerner Research Institute.

The new company, Shield Biotech, will complete preclinical development and seek permission from the FDA to test the vaccine as an investigational new drug in proof-of-concept, first-in-human clinical trials.

When will clinical trials begin?

Phase I trials are expected to start within two years and will take about three years to complete.

Who will be in the Phase I trial?

The first (Phase Ia) trial will involve women with triple-negative breast cancer who have recovered from current standard of care involving chemotherapy, radiation therapy, and/or surgery. This trial will determine the dose and frequency of vaccination needed to provide an optimum immune response. The second (Phase Ib) trial will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. This trial will focus on the safety of the vaccine by examining the removed breast tissue for any potential changes.

What will the Phase I trials tell us?

These trials are designed to establish the safety of the vaccine in women and to characterize and optimize the immune response. How can a patient enroll in the clinical trials?

Patients are not being enrolled yet, and the trials won’t begin until 2015. To stay updated on information on the clinical trial, please continue visiting this website and for information on other breast cancer trials visit the National Institutes of Health’s

For more information about Shield Biotech:

Read Press Release here

Taking a big step in the development of a new vaccine:

Read Dr. Tuohy’s HealthHub article here

For further questions, contact:

Opportunity for Support

To make a gift in support of Dr. Tuohy’s research and help usher the breast cancer vaccine into clinical trials: