Update: FDA allows testing of a vaccine designed to prevent breast cancer

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Update at a glance Clinical trials 
Study findings Questions for your doctor
Strength and Limitations Resources and reference
What does this mean for me?  



So far, most cancer vaccines treat cancer after it develops. The FDA has announced that they will allow a small phase I clinical trial to test whether a new vaccine to prevent breast cancer is safe for humans.


What is this update is about?

This update is about the FDA allowing a very early (phase I) clinical trial that will look at the safety of a vaccine to potentially prevent breast cancer.


Why is this update important?

This update is important because a vaccine to prevent breast cancer would be a major medical breakthrough that could dramatically reduce the number of women who are diagnosed with breast cancer and those who die of the disease. Each year, just over 1 in 10 (13 percent) women in the United States are diagnosed with breast cancer, and about 47,000 women die from this disease. 

The vaccine will be tested first in women with non-metastatic triple-negative breast cancer to determine whether it decreases their high risk of recurrence.  However, it is hoped that this vaccine can also decrease the overall occurrence of breast cancer.


Study findings

The road to approval to test a preventive breast cancer vaccine

The FDA is allowing an early phase clinical trial to test whether vaccination with the protein alpha-lactalbumin is safe. It will also look at whether it can decrease breast cancer recurrence in women with triple-negative breast cancer

The development of the alpha-lactalbumin vaccine is based on more than 10 years of research. In 2010, researchers published a study showing that the vaccine dramatically decreased breast cancer in mice.  Importantly, this study also found that the vaccine did not cause inflammation in normal non-breast tissue. In 2016, tests of the vaccine on human breast cancer cells grown in the lab, breast tumor samples and breast tumors in mice showed that it has the potential to be safe and effective.


How does this vaccine work?

The new vaccine works by training the immune system to kill cells that make alpha-lactalbumin, a protein that appears on breast cells late in pregnancy and during lactation. Once a woman is no longer pregnant or lactating the protein is no longer made. 

Women who develop breast cancer, particularly triple-negative breast cancer, also produce alpha-lactalbumin, which is found on breast cancer cells. 


Phase I clinical trial

The phase I trial is scheduled to begin at the Cleveland Clinic in the summer of 2021. It will test the safety of a vaccine against alpha-lactalbumin. It will also test whether the vaccine can decrease recurrence in women with non-metastatic triple-negative breast cancer who have a high risk of recurrence.  If this phase I trial is successful, other trials will test how well the vaccine reduces breast cancer in women who have not had the disease.

Like most phase I trials that test safety, this trial will be small.  It will include 30 men and women with non-metastatic triple-negative breast cancer who are at high risk of recurrence. See Clinical Trials below for more information.


Other cancer vaccines

Vaccines that prevent cancer

Researchers have been trying for years to develop a vaccine to prevent breast cancer. However, none of their efforts have been successful. Currently, only two vaccines that prevent cancer have been approved by the FDA: the HPV vaccine for cervical cancer and the hepatitis B vaccine for liver cancer. Both vaccines prevent cancers that are caused by viruses. This new vaccine does not target a virus protein. Instead, it will target breast cancer cells that make a human protein.   


Vaccines that treat breast cancer

Several vaccines to treat rather than prevent breast cancer are currently being developed. These treatments are called immunotherapies because they harness a patient's immune system to fight cancer.

A vaccine called NeuVax to treat HER2-positive breast cancer is furthest along in the testing process. In clinical trials, NeuVax appeared to delay recurrence in patients who had triple-negative breast cancer with a low expression of HER2 when added to standard maintenance therapy. (Up to 30 percent of breast cancers are HER2-positive.) Early studies have concluded, and phase III studies are expected to begin soon.

The Mayo Clinic has developed three immunotherapy vaccines related to breast cancer. Studies involving vaccines against triple-negative breast cancer and DCIS are currently enrolling participants. See Clinical Trials below for more information. The trials of another vaccine to treat HER2-positive breast cancer are no longer enrolling participants.


Strengths and limitations


  • Currently, no vaccines are approved by the FDA to prevent breast cancer. If successful, the alpha-lactalbumin vaccine will be the first to prevent breast cancer recurrence in women with triple-negative breast cancer who have few treatment options.
  • It may also prevent breast cancer in men and women who have not had the disease.



It is not yet known whether:

  • adult women will have an immune response to the alpha-lactalbumin vaccine. If their immune systems do not respond, then the vaccine may not work.
  • a history of lactation will prohibit an immune response to the vaccine.
  • expression of alpha-lactalbumin in non-breast cells will complicate immune response.
  • the vaccine will be effective in people with inherited mutations that are linked to breast cancer.


What does this mean for me?

  • It is not known whether or when this vaccine might be available to the public; even if it is successful, availability will likely take several years. If the vaccine proves to be effective and is approved for breast cancer prevention, women would not be eligible to receive it if they are breastfeeding or plan to breastfeed in the future.


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posted 5/25/21

This article is relevant for:

Patients with non-metastatic triple-negative breast cancer at high risk of recurrence.

This article is also relevant for:

People with breast cancer

People with triple negative breast cancer

People newly diagnosed with cancer

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Questions to Ask Your Doctor

  • Are any clinical trials of vaccines to treat breast cancer right for me?
  • Are any available targeted treatments such as immunotherapies right for me?

Open Clinical Trials

NCT04674306. Adjuvant therapy with an alpha-lactalbumin vaccine in triple-negative breast cancer. This study is planned to open for enrollment by Summer 2021, but is not yet enrolling patients as of this posting. It will look at the safety and most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat both men and women with non-metastatic triple-negative breast cancer.

NCT03012100. Multi-epitope folate receptor alpha peptide vaccine, GM-CSF, and cyclophosphamide in treating patients with triple negative breast cancer.  This study is looking at how well the folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stages 1 to 3 triple-negative breast cancer.

NCT03793829. Neoadjuvant multi-epitope HER2 peptide vaccine in patients with HER2-expressing DCIS (HER2Vaccine). This study is looking at the safety and effectiveness of a specific helper T-cell vaccine (H2NVAC) to prevent recurrence in patients with HER2-positive ductal carcinoma in situ (DCIS).

See FORCE Featured Research on clinical trials for patients with triple-negative breast cancer here.

Who covered this study?


FDA Clears Breast Cancer Vaccine For Clinical Trials This article rates 4.5 out of 5 stars

Breast Cancer News

Breast Cancer Vaccine Cleared by FDA for Human Testing This article rates 3.0 out of 5 stars

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