In 2010, Professor Vincent Tuohy of the Cleveland Clinic published his results on the first preventive breast cancer vaccine in the Nature Medicine journal. The study showed that 100 percent of mice bred to develop the disease did not express breast cancer in the experimental group. In 2013, enough funding was procured to begin Phase I clinical trials on the vaccine. The Cleveland Clinic is now awaiting FDA approval.

1. The Breast Cancer
Vaccine
Cleveland Clinic

2. Awaiting Phase I Clinical Trials

In 2010, Dr. Vincent Tuohy of the Cleveland
Clinic published his results on a preventive
breast cancer vaccine in Nature Medicine
– The research showed that 100% of the mice in the
experimental group did not develop the disease
despite being bred to grow breast tumors

In 2013, the Cleveland Clinic announced that it
is awaiting FDA approval to start Phase I clinical
trials on the breast cancer vaccine through its
spin-off company Shield Biotech

3. Phase I Divided into Two Parts
• The first part of the Phase
I trial will consist of
understanding the correct
dosage and frequency
– Triple-negative breast
cancer patients will be
followed
• The second part of the
study will consider the
safety of the vaccine for
women who are at risk of
breast cancer

4. The Creator of the
Vaccine
“We have proposed that breast cancer may be effectively
controlled by providing healthy cancer-free women with
pre-emptive immunity against emerging breast tumors.
We propose to provide women with an immune defense
or shield that will protect them from developing breast
cancer. Our data show that safe and effective immune
protection against this disease can be induced by
vaccinating against proteins that are no longer expressed
in aging breast tissues but are significantly over expressed
in triple-negative breast cancer, the most aggressive and
lethal form of this disease. We hope to provide women
with a safe, effective and relatively benign alternative to
invasive prophylactic mastectomy.”
- Dr. Vincent Tuohy

5. Supporting the Breast Cancer
Vaccine

“The Cleveland Clinic announced today
that it has secured the necessary funds to
move the preventive breast cancer vaccine
developed by Professor Vincent Tuohy in
2010 forward into a Phase I clinical trial to
see if it’s safe for use in women. As an
early supporter of this, the world’s first
preventive breast cancer vaccine, I am
thrilled that the money that has been
denied by traditional funding sources to
Professor Tuohy for the last three years
has finally materialized…. But we must not
get ahead of ourselves in rejoicing, for the
next step is to test Tuohy’s vaccine in a
small group of healthy volunteers to make
sure it is safe for use in women. Such a
clinical trial is called a Phase I study, and it
must – and will be – rigorously conducted
and reviewed. As happy as we are that
the funds required for such a study are
now at hand, we must be sober about
what lies ahead. “
• Dr. Kathleen T. Ruddy of the Breast
Health and Healing Foundation

6. Supporting the Breast Cancer
Vaccine

“The Cleveland Clinic announced today
that it has secured the necessary funds to
move the preventive breast cancer vaccine
developed by Professor Vincent Tuohy in
2010 forward into a Phase I clinical trial to
see if it’s safe for use in women. As an
early supporter of this, the world’s first
preventive breast cancer vaccine, I am
thrilled that the money that has been
denied by traditional funding sources to
Professor Tuohy for the last three years
has finally materialized…. But we must not
get ahead of ourselves in rejoicing, for the
next step is to test Tuohy’s vaccine in a
small group of healthy volunteers to make
sure it is safe for use in women. Such a
clinical trial is called a Phase I study, and it
must – and will be – rigorously conducted
and reviewed. As happy as we are that
the funds required for such a study are
now at hand, we must be sober about
what lies ahead. “
• Dr. Kathleen T. Ruddy of the Breast
Health and Healing Foundation