The search for a cure for cancer has been the holy grail of medicine for years. Apart from the only two cancer vaccines currently available – one for HPV, whose strains can cause cancer, including cervical cancer, and one for hepatitis B, which can cause liver cancer – they have been elusive.
Now, a breast cancer vaccine in human clinical trials aims to change that.
The vaccine is designed to prevent the recurrence of triple-negative breast cancer, which accounts for about 10% to 15% of all breast cancers and is particularly challenging to treat. That’s because the cancer cells in this case don’t have estrogen or progesterone receptors and don’t have enough HER2 proteins — which are the targets of the most effective breast cancer treatments.
It is also one of the most aggressive forms of breast cancer because it grows quickly and has a higher rate of recurrence—locally, in the breast area, or elsewhere in the body, known as metastasis. In fact, patients with triple-negative breast cancer have a nearly three times greater risk of recurrence within five years of diagnosis than patients who do not have that type of breast cancer.
So, needless to say, a vaccine to prevent the recurrence of this type of breast cancer would be a game changer.
Jennifer Davis, a 46-year-old nurse and mother of three who lives in Ohio, was the first person in the world to receive the vaccine in a clinical trial. Here’s why she decided to participate and how the vaccine works.
What made you want to participate in a breast cancer vaccine trial?
For Davis, this is personal. She was diagnosed with triple-negative breast cancer in September 2018. Shortly thereafter, she began cancer treatment at the Cleveland Clinic; it involved a bilateral mastectomy, as well as rounds of chemotherapy and radiation.
At a follow-up appointment at the Cleveland Clinic, she learned about the breast cancer vaccine trial — a 20-year trial based on research led by Vincent Tuohy, who died in January 2023. Human trials of the vaccine began in October 2021.
“My (health care) team told me about the vaccine that Dr. Toohey has been working on for a long time,” Davis tells Yahoo Lifestyle. They told her about the human phase of the trial, which is being conducted at the Cleveland Clinic. “So it’s been a blessing,” she said.
She shared, “I didn’t know much about triple negative breast cancer when I was diagnosed, but going through it, you learn a lot. This is that kind of breast cancer—that special Type – I can’t take any medication after that, no tamoxifen (a hormone therapy), and the relapse rate is high. If it does come back, the outcome isn’t the best. So I want to do something about it – The vaccine is the one for me.”
Additionally, as a nurse, Davis understands that clinical trials are “very important,” adding, “That’s how we advance medicine and make changes that, one day, will rid us of breast cancer.”
How does it feel to participate in a clinical trial?
For the trial, which is funded by the Department of Defense, “the first chemotherapy treatment will be no more than three years old,” Davis said. “The second guideline is you have to show no signs of recurrence. So there needs to be some testing.”
Once Davis was approved to participate in the trial, she received three injections, each two weeks apart, along with 15 other women. “They do lab work before every injection,” she said. “Other than a bump at the injection site, I didn’t have any side effects – just like any other shot or vaccine you get.”
Davis had two follow-up appointments as part of the trial and remains at Cleveland Clinic, where she received her final dose of the vaccine in November 2021. So far, the cancer has not returned.
How does getting the vaccine affect you?
“It changed my life,” Davis said. “I don’t think about relapse every day.”
As Davis explains, this is important because once you receive a cancer diagnosis like this, it stays with you. “I wouldn’t say you’ve never thought about it,” she said. But “the fact that it’s working” — based on Davis’ blood tests and immune system response, and that the cancer hasn’t come back yet — “gives you peace of mind, should it come back.”
She added: “Those thoughts have been put to rest. Now I’m really living a good life.”
Davis also thought about what the vaccine would mean for other women with triple-negative breast cancer — “the fact that one day it might be eliminated,” she said. “I’m excited to be a part of it.”
What experts say
Vaccines are medical tools that use the body’s immune system to help prevent certain diseases. So it can be a little confusing that the women participating in the vaccine’s initial human clinical trials already have triple-negative breast cancer. But for now, the goal of the vaccine is to prevent the same cancer from coming back, which occurs at a high rate.
Amit Kumar, chairman and CEO of Anixa Biosciences, said 42 percent of women with triple-negative breast cancer will develop the cancer again within five years. The company has a license to manufacture the vaccine being tested by the Cleveland Clinic. “It’s usually more aggressive, so the outcomes for these women aren’t very good,” he tells Yahoo Lifestyle. The goal of a breast cancer vaccine is to “eliminate recurrence in these women and ultimately prevent the development of cancer.”
While the current focus is on triple-negative cancer because “it’s the deadliest form,” Kumar said, “we eventually hope to conduct clinical trials on other types of breast cancer. “We may be able to eliminate breast cancer as a disease, just like We eradicated polio (in the United States) as did smallpox. “
How does the breast cancer vaccine work?
Justin Johnson, a program manager at Cleveland Clinic’s Lerner Research Institute, explained that the vaccine works by training the immune system to recognize alpha-lactalbumin, a beneficial protein typically found in breast milk. “In healthy tissue, alpha-lactalbumin is produced only in the breast, and only during lactation,” he tells Yahoo Life. “However, breast tumors often also express alpha-lactalbumin, particularly in the case of triple-negative breast cancer.”
As Kumar says: “If a woman doesn’t breastfeed, the only chance the protein will show up is cancer.”
Johnson explained that the vaccine helps the immune system “recognize and attack” emerging cancer cells by targeting this protein. “For women after childbearing age, the vaccine can provide safe and effective protection when breast cancer begins to develop,” he said.
How promising are the results so far?
The Phase 1 clinical trial began at the Cleveland Clinic two years ago, and “to date, we have vaccinated 16 women, all of whom were TNBC survivors, with the breast cancer vaccine,” Johnson said. “Side effects are generally mild and mainly include irritation at the injection site. Our data so far indicate that we generated robust immunity against the alpha-lactalbumin target in most subjects, even at the lowest dose tested. .”
Johnson added that while a successful immune response is critical to establishing protection against tumors, “we don’t yet know whether the vaccine will be clinically effective. “We plan to monitor subjects for breast cancer recurrence over the long term. “
“The ultimate goal of this research trial is to develop a vaccine that can prevent breast cancer in people at high risk,” Dr. G. Thomas Budd of Cleveland Clinic’s Taussig Cancer Institute, the study’s principal investigator, said in a statement. It’s a lofty goal, but it’s what we hope for. There are still many steps to complete before this can happen. It may not work, but you know this is one of those 1,000 steps of the journey you have to start. So we are taking the first steps. “
If larger clinical trials go well — followed by Phase 2, in which scientists hope to involve different groups of patients — Kumar believes the vaccine could be available within five years, “and for people like Jenny (Davis) So women who already have cancer and worry about it “coming back.” “
But he noted that the vaccine is still in the early stages of human testing. “We want to do the proper research and make sure it’s safe,” he said. “You have to make sure there are minimal side effects.”
Still, it’s hard for people like Kumar and Davis not to think about what it would mean to have an effective breast cancer vaccine. “If we could get women to take three shots and eliminate cancer — triple-negative cancer and eventually breast cancer — that would be awesome,” Kumar said. “This will also change the way cancer research is done.”