The first American woman to receive a vaccine scientists hope will prevent recurring bouts of an aggressive type of breast cancer said it has changed her life.
Jennifer Davis, a 46-year-old nurse and mom of three from Ohio was the first of 15 women in a clinical trial to have received the three-dose series of the vaccine as part of a Cleveland Clinic-run study, which involves patients who completed chemotherapy treatment for a specific form of breast cancer in the past three years.
In 2018, Ms Davis was diagnosed with triple-negative breast cancer, a form of the disease that makes up about 10 to 15 percent of breast cancer cases that can reoccur in between bouts of remission.
Human trials of the vaccine, which was developed to prevent the cancer from striking more than once, began in 2021 and Ms Davis received her third and final shot that same year.
She has been in remission for five years.
Now, the researchers have set their sights on recruiting women who have never had triple-negative cancer but are at higher risk in a bid to see if the vaccine could prevent the cancer from attacking in the first place.
46-year-old Jennifer Davis was diagnosed with triple-negative breast cancer in 2018. She was enrolled soon after in the Cleveland Clinic cancer vaccine trial and received her third and final shot in fall 2021
Triple-negative breast cancer only makes up about 10 percent of all breast cancers, yet it accounts for roughly 40 percent of deaths. It also recurs often, meaning women who have it likely have to go through multiple of chemotherapy and other strenuous therapies
Jennifer Davis noticed a lump in her breast in February 2018 and underwent a biopsy to rule out cancer. And it did at first. But as months went by, the lump got bigger and doctors decided to conduct another biopsy in September 2018.
That’s when doctors detected the cancer and diagnosed her with triple-negative breast cancer. Following the news, Ms Davis was quick to seek out the best treatments available.
She began chemotherapy and underwent a double mastectomy, a surgical procedure to remove the breasts, followed by 26 rounds of radiation. The triple-negative breast cancer was still in stage two, meaning it had not yet spread to other parts of her body.
Ms Davis has been cancer free for five years and credits the vaccine with changing her life
This led her to the Cleveland Clinic’s Phase 1 trial, which was decades in the making, to test a series of shots that target a lactation protein, α-lactalbumin.
This protein is found in breast milk during late pregnancy and lactation, but is also extremely prevalent in cases of human triple-negative breast cancers (TNBC).
The vaccine targets this protein if cancer develops and will prompt a strong immune system response to attack the tumor and prevent it from growing.
Now, with five years of remission under her belt and no signs the cancer will return, Mrs Davis has said: ‘It’s changed my life.
‘I don’t think about recurrence every single day.’
Blood testing and immune system assays have shown no signs of recurrence or negative side effects.
Dr Megan Kruse, breast medical oncologist for Cleveland Clinic, said: ‘There is a window of time after a patient’s diagnosis and treatment that they are eligible for this study, and thankfully Jen was still within that window and actually became our first patient who enrolled in the trial and got treated with the vaccine.’
Cells in triple-negative breast cancer do not have estrogen or progesterone receptors, which are proteins on certain tumor cells that hormones stick to, allowing cancer cells to grow and multiply.
Women like Ms Davis with triple-negative breast cancer also lack a sufficient amount of Human epidermal growth factor receptor 2 (HER2) which plays a major role in keeping breast cells healthy by controlling how fast they divide, grow, and repair themselves.
Ms Davis was quick to seek treatment, which is key to increasing the odds of survival. If detected and treated early, the five year survival rate exceeds 90 percent. But if the cancer has already spread, that rate falls to about 12 percent
The vaccine targets a protein called α-lactalbuminm which only exists in the body when a woman is lactating or during breast cancer formation. The vaccine trains the immune system to destroy cells making that protein, meaning that when cancer cells arise, the immune system will destroy them and they will never have a chance to multiply into a tumor
Dr Justin Johnson, program manager at Cleveland Clinic Lerner Research Institute, and co-developer of the vaccine, told Yahoo Life: ‘The side effects have generally been mild, consisting mainly of irritation at the injection sites.
‘Our data so far shows that we have generated robust immunity to the alpha-lactalbumin target in the majority of the subjects, even at the lowest dose tested.’
All triple-negative breast cancer is HER2-negative, which is also the most common form of breast cancer overall, accounting for nearly 80 percent of cases.
Triple-negative cancer specifically only makes up 10 to 15 percent of all breast cancer cases, yet it accounts for an estimated 40 percent of deaths due to breast cancer.
Mrs Davis said: ‘I did not know a lot about [it] when I was diagnosed, but going through everything, you learn so much. It’s just that kind of breast cancer — that particular type — there’s nothing I can take afterward, no tamoxifen [a type of hormone therapy], and recurrence is high.
‘If it does come back, outcomes are not the greatest.’
Women who start treatment in the early stages of the disease are on average, about 91 percent as likely as women who don’t have that cancer to live for at least five years after being diagnosed.
But if the cancer has spread elsewhere throughout the body such as to the lungs, bones, or liver, that survival rate plummets to just 12 percent.
So far, none of the 15 women initially included in the trial have seen their cancer return.
Dr Amit Kumar, CEO of Anixa Biosciences, the company developing the vaccine, told DailyMail.com this summer: ‘We might be able to eliminate breast cancer as a disease, just like we have eliminated polio and smallpox.
‘We believe that within five years, it’ll be on the market for people like Jenni, who had breast cancer and are worried about recurrence. A couple of years after that, it should be available for all women, including women who’ve never had breast cancer. It is very exciting.’
Mrs Davis, for her part, said she was happy to be a part of the effort to hopefully eliminate this type of breast cancer entirely.
