Developing a vaccine to prevent breast cancer

Progress on a Vaccine to Prevent Breast Cancer

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We really are living in remarkable times for medical research. Based on scientific knowledge that was gained over many years, vaccines that are effective in preventing death and serious illness from the virus that causes COVID-19 were developed, manufactured and began to be distributed in the incredible timeframe of less than a year.

The experts tell us that, thanks to these vaccines, countless lives will be saved. Everyday life is already beginning to return to something much more like normal for many of us.

If we can accomplish something this amazing, couldn’t we also make vaccines to reduce the incidence of major cancers?

In fact, work has been quietly proceeding for a number of years on a vaccine that has as its objective either preventing or drastically reducing the incidence of breast cancer.

The research is being conducted through the National Breast Cancer Coalition’s Artemis Project.

I wrote about the Artemis vaccine project at an earlier phase of the work in this post. It’s time for an update now, as this experimental vaccine will soon begin testing in a Phase I clinical trial.

The Artemis Project

Cancer research often tends to be conducted in silos, where researchers more forward one step at a time on projects that can take many years or even decades to reach fruition. By contrast, NBCC’s Artemis Project takes a much different approach.

The Artemis initiative brings together participants from many disciplines, including immunology, biophysics, genetics, molecular biology and clinical oncology, along with trained patient advocates. The purpose of the cross-disciplinary interaction is to break through the silos and stimulate the most creative thinking possible to achieve the overall goals of stopping women and men from getting breast cancer and stopping them from dying from breast cancer.

There are numerous other initiatives, in addition to the vaccine, also being pursued under Artemis. These include projects aimed at preventing deaths from metastatic breast cancer, as well as additional projects focused on primary prevention of the disease. You can read about these initiatives in the latest annual report of the Artemis Project.

Vaccine Approach

We’re all very familiar, especially now in this COVID era, with vaccines to prevent diseases caused by viruses. Certain types of cancer are also caused by viruses. For example, certain strains of the human papilloma virus (HPV) cause cervical cancer, and there is an effective preventive vaccine against cervical cancer that targets these HPV strains.

Researchers wondered whether viruses might also be involved in the development of breast cancer. Early work under the Artemis Project investigated this possibility, but did not find any evidence that viruses play a significant role in breast cancer.

So instead the researchers pursued a somewhat different approach. They looked for cellular signaling pathways that are activated early in the development of breast cancer–long before any physical changes would be evident.

The particular breast cancer pathways they zeroed in on are associated with overexpression of certain proteins or “antigens” that can potentially be targeted with a vaccine without harming normal cells in the body.

What Has Been Accomplished So Far

The research team came up with a list of potential antigen targets, and eventually selected six of the antigens to be the targets of the new vaccine. The set of antigens chosen covers all three major subtypes– hormone receptor-positive breast cancer, HER2-positive breast cancer and triple negative breast cancer.

As this is a vaccine that will ultimately be given to healthy individuals to prevent breast cancer, a focus on safety has been paramount in the project. Each of the six antigens selected has already been tested in hundreds of patients in other vaccine trials, although the six have not yet been tested in this particular combination.

NBCC is partnering with the Mayo Clinic Cancer Center to develop the vaccine and begin testing of the vaccine in a Phase I clinical trial. The research team has also been working closely with the FDA, whose approval is needed for clinical testing to begin.

Moving Forward

Dr. Keith Knutson, Director of the Mayo Clinic Cancer Center’s Immunology and Immunotherapy Program, is leading the Artemis vaccine project. He presented an update at NBCC’s annual Advocate Leadership Summit in May 2021.

Dr. Knutson said that the vaccine has now been developed and a protocol for a Phase I clinical trial involving about 30 participants has been prepared.

The vaccine will be given in two doses, 30 days apart, similar to the COVID vaccines. But it will be a little different in that the two doses will not be identical. The two doses will use two different technologies for delivering the vaccine material to the cells in order to trigger a strong immune system response.

In addition to the Mayo Clinic Cancer Center, the project is also partnering with the National Cancer Institute’s Division of Cancer Prevention for large scale manufacturing of the vaccine.

Under a preliminary timeline, the first clinical trial patient will begin receiving the vaccine in the first quarter of 2022. This small trial would be completed by the end of 2022 and a report of the study completed by the first quarter of 2023.

The focus of the trial will be on safety and tolerability, and on evaluating the immune response generated by the vaccine. However, Dr. Knutson stressed that there has been a lot of work done over many years with vaccines that specifically attack tumors, but not normal tissues in the body, and they’ve been found to be very safe.

Participants in the Phase I trial will be individuals who have already been treated for breast cancer and either have metastatic breast cancer with a low burden of mets, or have been diagnosed with stage 3 breast cancer and have completed treatment. These are individuals who could potentially benefit from the vaccine even though they have already been diagnosed with breast cancer.

In future phases of clinical research, Dr. Knutson said that the vaccine will be tested in various groups of healthy individuals with higher than average risk for breast cancer. These could include individuals who have BRCA mutations, patients who have been diagnosed with benign breast disease or atypical hyperplasia–of which about 30% will eventually develop breast cancer, or individuals who have higher risk based on genetic models or other models.


The development of successful vaccines against the virus that causes COVID-19 has shown us what is possible when we put our collective efforts toward it. Similar progress against major cancers including breast cancer is possible too.

One part of that effort will be the development of an effective vaccine to prevent breast cancer. We’ll continue to follow developments in this story closely.

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