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Update: Breast cancer vaccine trial begins enrolling people with BRCA1 and PALB2 mutations


A new vaccine was first tested on people diagnosed with triple-negative breast cancer. The vaccine is now being tested to prevent breast cancer among people with an inherited mutation in BRCA1 or PALB2 who are at high risk and who are planning to have a risk-reducing mastectomy. (Posted 1/9/23) Este artículo está disponible en español.

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Breast cancer vaccine trial begins enrolling people with BRCA1 and PALB2 mutations
Glossary on


Most relevant for: People with a BRCA1 or PALB2 mutation undergoing prophylactic bilateral mastectomy.
It may also be relevant for:

  • people with triple negative breast cancer
  • people with a genetic mutation linked to cancer risk

Relevance: Medium

Research Timeline: Human Research

Relevance Rating Details

What is this update about?

Scientists have been working for years to develop a vaccine that will prevent breast cancer. A small, early-phase study has begun to test whether this new vaccine is safe and effective in humans.

Why is this update important?

Initially, this trial was open only to people with non-metastatic () to see if the vaccine could prevent a recurrence. We published an XRAY review on the press release about the opening of the study. However, the trial has recently expanded to include people who do not have breast cancer but who are at high risk of developing due to an in or .

This next phase of the study will allow researchers to determine if the vaccine can lower the risk for breast cancer in people who are high risk but have not been diagnosed with the disease.

Breast cancer vaccine trial eligibility

Initially, the trial only included those with (phase 1a). The trial now has opened to people at high risk of developing due to an (phase 1b). Both versions of the trial are currently recruiting participants.

  • Phase 1a (the group) is recruiting people diagnosed with who have:
    • 2-3 .
    • completed all standard therapy.
    • no evidence of recurrence within 3 years after diagnosis.
  • Phase 1b (the prevention group) is recruiting people who:
    • are at high risk of developing breast cancer due to an in or and are planning to have a prophylactic mastectomy.
    • have no evidence of breast cancer.

Phases 1a and 1b will test not only the safety of the vaccine but also its effectiveness in preventing breast cancer. Phase 1a will test whether the vaccine can decrease recurrence in people who have been diagnosed with non-metastatic . Phase 1b will test how well the vaccine prevents breast cancer in high-risk people ( and mutation carriers) who have not had the disease.

This trial is being conducted at the Cleveland Clinic in Cleveland, Ohio. More information can be found here. A third arm of the study, which is not yet enrolling participants, will test the vaccine in people with who are being treated with the checkpoint inhibitor pembrolizumab.

What does the vaccine do?

The vaccine trains the immune system to kill cells that make a substanced called "alpha-lactalbumin," a protein that appears on breast cells late in pregnancy and during breastfeeding. Once a woman is no longer pregnant or breastfeeding the protein is no longer made. However, women who develop breast cancer, particularly , also produce alpha-lactalbumin on their breast cancer cells.

The development of this vaccine is based on more than 10 years of research. In 2010, researchers published study results 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 on lab-grown human breast cancer cells, breast tumor samples and breast tumors in mice showed that the vaccine has the potential to be safe and effective.

Like most phase I trials that test safety, this trial is small. Phase 1a will include up to 30 people with non-metastatic who are at high risk of recurrence. The number of people who will be enrolled in Phase 1b has not been posted yet on

What does this mean for me?

This research is early and scientists cannot yet tell how well the vaccine prevents cancer. However, if you have a or inherited mutation, have never been diagnosed with cancer and are planning a risk-reducing mastectomy, you may qualify for this study.

You may also qualify for participation if you have been diagnosed with 2 or 3 and you have a high risk of your cancer returning.

Currently, the study is enrolling patients only in Cleveland, Ohio, so participants outside of the area would need to travel to participate. As this research continues, participation may be expanded to more cancer centers. If you are interested in participating, speak with your doctor and contact the study team listed on to see if you qualify for enrollment.

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, people who are breastfeeding or plan to breastfeed in the future would not be eligible to receive it.


Budd G, Johnson JM, Rhoades E, et al. Phase I trial of an alpha-lactalbumin vaccine in patients with operable (). Poster OT2-10-02 presented at the San Antonio Breast Cancer Symposium, December 6-10, 2022.

Disclosure: 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.

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posted 1/9/23

Questions To Ask Your Doctor
Questions To Ask Your Doctor

For people diagnosed with TNBC:

  • 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?

For people who have never been diagnosed with breast cancer:

  • Are any clinical trials of vaccines to prevent cancer right for me?
  • Am I considered at high risk for ?
  • Are there any other medications I can take to lower my risk for breast cancer?

Open clinical trials
Open clinical trials

The following are breast cancer screening or prevention studies enrolling people at high risk for breast cancer.   

Additional risk-management clinical trials for people at high risk for breast cancer may be found here.

Updated: 01/24/2024

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