Breast Cancer Vaccines: Types, Goals, and Availability

In 2021, the Food and Drug Administration (FDA) cleared a new breast cancer vaccine to start clinical trials. You may wonder, what is a breast cancer vaccine, how does it work, and who gets one?

Breast cancer vaccines aim to either prevent breast cancer from coming back or help treat it. They work by training the body’s immune system to fight cancer cells, just as a flu vaccine works by training the body to fight the flu virus.

Many breast cancer vaccines are currently in development, and several have already been tested in early clinical trials. A clinical trial tests a treatment or preventive measure in human participants.

No breast cancer vaccine has been approved for public use, and testing is still ongoing. It will be many years before a breast cancer vaccine is approved, and then, these vaccines are often specific for certain people with cancer or at high risk for cancer. 

This article will explain what a breast cancer vaccine is, when it will be available, and what it will cost. It will cover how these vaccines will help treat breast cancer, which types of cancer they may help, and how to access breast cancer vaccines through a clinical trial. 

The Goal of Breast Cancer Vaccines

The goal of breast cancer vaccines is to help the body’s immune system seek out and fight back against breast cancer cells.

Preventive vs. Treatment Vaccines

Breast cancer vaccines aim to destroy cancer cells either when they first develop (preventive vaccine) or when they’ve already formed a tumor (treatment vaccine, as follows:

• Preventive vaccines may be given to a broader population, maybe those at high risk of developing cancer. They include vaccines that prevent cancer by priming the immune system to fight back against cancer-causing viruses like human papillomavirus (HPV). 
• Treatment vaccines would be given to a specific subset of people with breast cancer and used in combination with other treatments to fight breast cancer that has already developed. 

Types of Breast Cancer Vaccines 

Many types of breast cancer vaccines are in development, but none have made it past phase 2 clinical trials.

Different Vaccine Technologies

Breast cancer vaccines teach the immune system to fight cancer. They do this by introducing cancer-related proteins (or other molecules like sugars or fats) to the body in a way that encourages the immune cells to attack the cancer cells.

A vaccine may contain a protein or part of a protein (peptide). It may include a strand of messenger RNA (mRNA) or DNA—the molecules the body uses to create proteins. They may transmit the instructions for a protein in a modified virus.

Breast cancer vaccines are sometimes created using the body’s immune cells, called dendritic cells. Medical professionals remove these cells from the body of a person with cancer and train them in the lab to attack cancer. They’re then injected back into the person.

Alpha-Lactalbumin Vaccine for Triple-Negative Breast Cancer 

Researchers at the Cleveland Clinic in Ohio have been developing a breast cancer vaccine. The alpha-lactalbumin vaccine is for triple-negative breast cancer. It aims to help the body prevent cancer from returning in people at high risk.

Triple-negative breast cancer is a rarer subtype of breast cancer. It's harder to treat because it does not produce receptors for the hormones estrogen and progesterone, so hormone therapy is not effective against it. It is also HER2-negative, so it does not respond to targeted treatments against the presence of HER2, the receptor for the protein human epidermal growth factor.

The alpha-lactalbumin vaccine allows the body's immune cells to recognize, attack, and kill cancer cells expressing alpha-lactalbumin. This protein is expressed during lactation (breast milk production) and by triple-negative breast cancer cells.

Because alpha-lactalbumin is a protein that the body also expresses during lactation, people may be unable to breastfeed if they take the vaccine. Many people with triple-negative breast cancer will have surgery to remove all or part of their breasts, so breastfeeding may not be an issue.

But because a person wouldn't be able to breastfeed after taking this vaccine would mean the vaccine is unlikely to be a good candidate for a general preventive triple-negative breast cancer vaccine.

The goal of the triple-negative breast cancer vaccine is to prevent the cancer cells from ever reaching a size at which they could come back and inflict lethal damage on the body.

The team is recruiting for an early phase 1 clinical trial. People eligible for the test are those with stages 2A to 3C triple-negative breast cancer at a high risk of returning after initial treatment.

Future trials will include women who have never had cancer but are at increased risk of developing triple-negative breast cancer. It will be many years before it's known how well the vaccine works and if it will be available to the public.

When Will Breast Cancer Vaccines Be Available? 

There isn't a firm date on when breast cancer vaccines will be available to the general public. Some breast cancer vaccines are currently in clinical trials. 

A clinical trial tests new treatments or combinations of treatments and compares them to standard-of-care treatments for cancer to see if they are safe, effective, and work better.

Clinical trials have multiple phases, including:

• A phase 1 clinical trial is a small study to determine if the vaccine is safe for the population being treated. It's the first time the vaccine is being given to people. They may also test how much of the vaccine to use.
• A phase 2 clinical trial will test if the vaccine works. It will be given at a specific dose to a particular population in a large enough number to provide results that could be analyzed to show that the vaccine is effective. 
• A phase 3 clinical trial compares the vaccine's effectiveness and safety against current treatments. It's larger than phases 1 and 2 trials and includes both a test group and a standard therapy group.

Each phase typically takes at least a few years. It may take even longer if the specific cancer type and the treatment stage are rare, making it hard to find new trial participants.

The alpha-lactalbumin vaccine for triple-negative breast cancer began an early phase 1 trial in 2021, which was still recruiting participants in late 2022. Phase 1 of the clinical trial should take about two years.

To participate in a breast cancer clinical trial, you'll need to find clinical trials for your stage and type of cancer currently enrolling participants near you. There is no single place to see them all.

You can start with the National Cancer Institute's (NCI) database and clincialtrials.gov. Also, check with clinical trial listing services like CenterWatch. For breast cancer, there are many collaborative clinical trial networks.

For a tailored search, call the NCI's Cancer Information Service at 800-4-CANCER (800-422-6237) and select option 2. You may instead connect with their cancer information specialists online.

Once you've found a breast cancer clinical trial that you may want to participate in, you can talk with your cancer care team about how to apply and get enrolled in the study. 

How Much Will Breast Cancer Vaccines Cost?

The cost of a breast cancer vaccine is unknown. It depends on how expensive it is to make and the methods used to create it. It also depends on the demand. Often a drug or vaccine with limited use will be more expensive than one given to the general population. 

Widely distributed vaccines for children and adults typically range from $25 to $250 a dose. These are made in bulk and dispensed by the millions.

But more complex personalized cellular vaccines made by removing and training immune cells in the lab will be much more expensive. Extensive hands-on time is required to collect, grow, and prepare the cells and infuse them into the body. 

For example, the prostate cancer vaccine Provenge (sipuleucel-T) trains the body's immune cells to detect and fight back against prostate cancer cells expressing the prostatic acid phosphatase protein on their surface. The body's immune cells are trained and added back through three infusions at almost $100,000.

A Combined Approach to Breast Cancer Treatment 

Depending on how a breast cancer vaccine works, it may be used in different ways for cancer prevention or cancer treatment. Many breast cancer vaccines will work only on a specific subset of people at high risk for a particular type of breast cancer, as the vaccine will likely target specific molecules created by the cancer cell.

For example, the alpha-lactalbumin vaccine for triple-negative breast cancer is designed to prevent cancer from returning, not treat it. It would only apply to people who have triple-negative breast cancer, have finished treatment, and are at a high risk of recurrence or those at an increased risk of developing triple-negative breast cancer.

Other breast cancer vaccines may be used as a type of treatment. Breast cancer treatments typically include radiation, chemotherapy, and surgery. Other treatments include targeted therapy and immunotherapy. Breast cancer vaccines can be seen as immunotherapy, priming the body’s immune system to fight back against cancer.

Research has suggested that breast cancer treatment vaccines are likely most effective when paired with HER-2 targeted therapy and immune checkpoint-blocking immunotherapies (these allow the immune system to vigorously attack cancer some types of cancer cells).

Summary

Breast cancer vaccines aim to stop breast cancer from forming or growing. Breast cancer vaccines are in their infancy. Researchers are working on them in the lab or testing them in clinical trials. 

Breast cancer vaccines work in many ways. Some stop infections with cancer-causing viruses such as human papillomavirus (HPV). Preventive vaccines aim to stop breast cancer from forming. Treatment vaccines work with other breast cancer treatments to improve the outlook.

Vaccines prime the body’s defenses using proteins, parts of proteins, changed viruses, or many other ways. A type of vaccine called dendritic cell vaccine uses the body’s defense cells to fight the tumor. Doctors change the person’s cells in the lab and then they're reintroduced to the patient to fight cancer. 

Currently, only people in a clinical trial have access to breast cancer vaccines. These trials are open to people with specific types and stages of cancer.

Clinical trials take years to complete, and no breast cancer vaccine has passed phase 2. It will be many years before the public can access a breast cancer vaccine. Some breast cancer vaccines may have very high costs.

A Word From Verywell

It can be tempting to be hopeful about new cancer therapies. But cancer vaccines are a treatment approach still in early development, especially for breast cancer. Since a vaccine is years away, enrolling in a breast cancer vaccine clinical trial may allow you to access experimental vaccines before they are FDA approved and become available widespread.