| Daily Briefing

A vaccine against breast cancer? What to know about Cleveland Clinic's new trial.

Cleveland Clinic has launched the first clinical trial to test a vaccine against triple-negative breast cancer—and if successful, researchers are hopeful that vaccines for other types of cancer may also be possible in the future.


Triple-negative breast cancer is considered one of the most aggressive and deadly forms of the disease—largely because it doesn't usually respond to hormonal or targeted therapies, Axios reports.

According to the American Cancer Society, triple-negative breast cancer makes up around 10% to 15% of all breast cancers, but it accounts for a disproportionately high percentage of breast cancer deaths and has a higher rate of recurrence.

In addition, roughly 70% to 80% of breast tumors that occur in patients with BRCA1 gene mutations are triple-negative breast cancer. This type of cancer is also twice as likely to occur among Black women.

Cleveland Clinic launches trial to test breast cancer vaccine

Cleveland Clinic on Tuesday announced a first-of-its-kind phase I clinical trial to test a vaccine targeting triple-negative breast cancer.

"The vaccine approach represents a potential new way to control breast cancer," said Vincent Tuohy, a staff immunologist at Cleveland Clinic's Lerner Research Institute who developed the vaccine with Anixa Biosciences. "The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women."

According to Cleveland Clinic, the vaccine targets a breast-specific lactation protein called α-lactalbumin. This protein is not found in normal, aging tissues post-lactation, but it is present in the majority of triple-negative breast cancer cases. Activating the immune response against this protein will provide pre-emptive immune protection against emerging breast tumors that express α-lactalbumin.

Previously, pre-clinical research led by Tuohy, which was published in Nature Medicine, found that activating the immune system against α-lactalbumin was effective at preventing breast tumors in mice. A single vaccination was found to prevent breast tumors from occurring, and it also inhibited the growth of existing tumors in mouse models.

The new study, which is funded by the Department of Defense, aims to determine the highest vaccine dose patients with early-stage triple-negative breast cancer can tolerate.

The study will include 18 to 24 patients who have finished treatment for the disease within the last three years and are tumor-free but at high risk of recurrence. Participants will receive three vaccinations, given two weeks apart, and be closely monitored for side effects and immune response. According to Cleveland Clinic, a subsequent trial of the vaccine will include cancer-free participants who have undergone voluntary bilateral mastectomies due to a high risk of developing breast cancer.

The study is expected to be completed in September 2022.

"We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” said G. Thomas Budd, a researcher at Cleveland Clinic's Taussig Cancer Institute and the study's principal investigator.

In addition, Tuohy said he believed vaccines could also be used to target other types of cancers in the future.

"This vaccine strategy has the potential to be applied to other tumor types," he said. "[Cleveland Clinic's] translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had." (Cleveland Clinic news release, 10/26; Chen, Axios, 10/26; Beals, The Hill, 10/26)

Advisory Board's take

There is only one FDA-approved vaccine that prevents cancer. What did we learn?

By Lindsey Paul and Ashley Riley 

Cancer prevention has come a long way. The possibility of preventing triple-negative breast cancer—and the potential for this technology to be applied to other cancers in the future—is a deeply exciting prospect. However, vaccine development is a long process, with no guarantee the vaccine will end up getting approved. And while vaccines for Covid-19 were developed relatively quickly, there was also a global pandemic fueling the urgency and influx of resources and funding necessary to expedite the process. When considering vaccine development for breast cancer, even if the vaccine is eventually approved, there will likely be many hurdles to widespread adoption. We’ve seen this firsthand with the HPV vaccine, which is currently the only FDA-approved vaccine to prevent certain cancer-causing infections.

The HPV vaccine rollout has served as a learning experience for providers, and the takeaways should be applied to new cancer vaccines. There are three key lessons with implications for the adoption of a triple-negative breast cancer vaccine in the future.

  1. Adoption can be slow, even when the benefits are clear. When the first HPV vaccine was approved by the FDA in 2006, it was immediately recommended by the CDC for use among teenage girls. But six years later, only 28% of girls ages 13-15 were fully vaccinated. While adoption has grown since then—by the most recent 2019 estimate, 54.6% of girls were vaccinated—rates are still below the national target of 80%. When it comes to new forms of cancer prevention, lack of patient education, misinformation, and fears about side effects can contribute to low adoption rates.


  2. Patient education is key to minimizing hesitancy. Many studies have demonstrated that provider actions, such as offering video education or keeping discussions brief and assertive, can influence HPV vaccine adoption rates. These education efforts can also be great opportunities for cancer programs to creatively engage with their local communities. For example, Upstate Cancer Center partnered with local school districts and artists on multiple community initiatives to raise awareness about head and neck cancer.


  3. When fully embraced, vaccination has the promise to significantly lower cancer incidence. In a 2019 meta-analysis, researchers found that HPV vaccinations were highly effective at preventing HPV and precancerous lesions, which can predict cervical cancer. These results demonstrated the vaccine’s ability to protect patients from HPV-related cancers and even eliminate cervical cancer entirely with high enough vaccination rates. A vaccine for triple-negative breast cancer could have a similarly significant impact on reducing incidence and mortality among some of the most vulnerable patient populations, but cancer programs should consider and plan for how this could impact their volumes.

While it could be years until a vaccine for triple-negative breast cancer hits the market, this groundbreaking trial is a hopeful sign of the future of cancer prevention—so it is worth thinking about how we can best prepare for the new frontier. In the meantime, providers should stay updated on the vaccine’s development, look for opportunities to enroll their patients in clinical trials for the vaccine, and manage patient expectations for when such a vaccine might become available.

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