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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
Strengths and limitations Resources
What does this mean for me?  



So far, most cancer vaccines treat cancer after it develops. The 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. 

THIS INFORMATION HAS BEEN UPDATED on 10/12/2021: The clinical trial discussed in this XRAY review has begun recruiting participants.  Researchers hope to enroll 24 patients with non-metastatic . The trial is being conducted at the Cleveland Clinic in Cleveland, Ohio. More information on this trial can be found here.

What is this update is about?

This update is about the 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 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 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

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 , also produce alpha-lactalbumin, which is found on breast cancer cells. 

Phase I clinical trial

The phase I trial has begun at the Cleveland Clinic. 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 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 is small. It will include 24 men and women with non-metastatic 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 breast cancer is furthest along in the testing process. In clinical trials, NeuVax appeared to delay recurrence in patients who had with a low expression of when added to standard . (Up to 30 percent of breast cancers are .) Early studies have concluded, and phase III studies are expected to begin soon.

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

Strengths and limitations


  • Currently, no vaccines are approved by the to prevent breast cancer. If successful, the alpha-lactalbumin vaccine will be the first to prevent breast cancer recurrence in women with 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 breast-feeding will keep people from having an immune response to the vaccine.
  • the presence of alpha-lactalbumin in non-breast cells will affect the immune response.
  • the vaccine will work in people with inherited mutations that are linked to breast cancer.

What does this mean for me?

If you have been diagnosed with 2 or and have a high risk for your cancer to come back, you may qualify for the research study. Currently, the study is only open and enrolling patients in Cleveland, Ohio. As this research continues, more cancer centers may begin to enroll patients. If you are interested in participating, ask your doctor if you qualify for this study. 

It is not known whether or when this vaccine might be available to the public. Even if the research 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


Anixa Biosciences. (December 21, 2020). Anixa Biosciences and Cleveland Clinic Announce Clearance to Initiate Clinical Trial of Breast Cancer Vaccine.

Tuohy VK, Jaini R, Johnson JM, Loya MG, Wilk D, Downs-Kelly E, Mazumder S. Targeted Vaccination against Human α-Lactalbumin for and Primary Immunoprevention of Triple Negative Breast Cancer. Cancers. 2016; 8(6):56.

Jaini R, Kesaraju P, Johnson JM, Altuntas CZ, Jane-Wit D, Tuohy VK. An autoimmune-mediated strategy for prophylactic breast cancer vaccination. Nature Medicine. 2010; 16(7):799-803.



FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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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Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) has guidelines for treatment of TNBC, which includes the following:

  • Genetic testing:
    • All people diagnosed with at any age meet guidelines for genetic counseling and testing. 
  • Treatment for TNBC:
    • For small tumors (0.5 cm or smaller) with no positive , the guidelines don't recommend chemotherapy except for patients at high risk for recurrence.
    • For small tumors (larger than 0.5 cm) with 1 positive lymph node or tumors between 0.6 and 1.0 cm, consider .
    • For tumors that are larger than 1.0 cm,  is recommended.  
    • For  2 or  3  in people who are at high risk for recurrence, the panel recommends pembrolizumab (Keytruda) in combination with chemotherapy followed by pembrolizumab.
    • For people with an inherited or mutation who are at high risk for recurrence, consider olaparib for one year after chemotherapy is completed. 
    • For people with remaining cancer after chemotherapy, the guidelines recommend capecitabine.  
    • For post-menopausal, node-negative patients who are at high risk for recurrence, or post-menopausal node positive patients, consider bisphosphonate treatment for 3-5 years. 

Updated: 02/23/2024

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Are any clinical trials of vaccines to treat breast cancer right for me?
  • What is my of cancer?
  • Am I considered at high risk for a recurrence of my cancer?
  • Are any available targeted treatments such as immunotherapies right for me?

Open Clinical Trials
Open Clinical Trials

The following are studies enrolling people with , .  

A number of other clinical trials for patients with TNBC can be found here.

Updated: 02/22/2024

Who covered this study?


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

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

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