The first American woman to receive a vaccine that scientists hope will prevent recurring attacks of an aggressive form of breast cancer said it has changed her life.
Jennifer Davis, a 46-year-old nurse and mother of three from Ohio, was the first of 15 women in a clinical trial to receive the three-dose series of the vaccine as part of a Cleveland Clinic study involving patients who have completed chemotherapy treatment for a specific form of breast cancer within the past three years.
In 2018, Ms. Davis was diagnosed with triple-negative breast cancer, a form of the disease that accounts for about 10 to 15 percent of breast cancer cases and can recur between periods 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 researchers have set their sights on recruiting women who have never had triple-negative cancer but are at higher risk, in an effort 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. Soon after, she was enrolled in the Cleveland Clinic’s cancer vaccine trial and received her third and final shot in the fall of 2021.
Triple-negative breast cancer makes up only about 10 percent of all breast cancers, yet is responsible for about 40 percent of deaths. It also often comes back, meaning that women who have it are likely to have to undergo multiple 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 that’s what happened initially. But as the months passed, the lump grew larger and doctors decided to perform another biopsy in September 2018.
That’s when doctors discovered the cancer and diagnosed triple-negative breast cancer. Following the news, Ms Davis quickly sought out the best treatments available.
She began chemotherapy and underwent a double mastectomy, a surgical procedure to remove the breasts, followed by 26 radiation treatments. The triple negative breast cancer was still in stage two, meaning the disease had not yet spread to other parts of her body.
Ms Davis has been cancer-free for five years and says the vaccine has changed her life
This led her to the Cleveland Clinic’s Phase 1 trial, decades in the making, to test a series of injections that target a lactation protein, α-lactalbumin.
This protein is found in breast milk during late pregnancy and lactation, but is also extremely common in cases of human triple-negative breast cancer (TNBC).
The vaccine targets this protein when cancer develops and will trigger 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 of the cancer returning, Mrs Davis has said: ‘It has changed my life.
“I don’t think about a repeat every day.”
Blood tests and immune system tests have shown no signs of recurrence or negative side effects.
Dr. Megan Kruse, a medical oncologist for the Cleveland Clinic, said, “There is a period of time after a patient’s diagnosis and treatment that they are eligible for this study, and fortunately Jen was still within that period and essentially became our first patient to enrolled in the trial and was 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 an adequate amount of human epidermal growth factor receptor 2 (HER2), which plays an important role in keeping breast cells healthy by controlling how quickly they divide, grow and repair themselves.
Ms. Davis sought treatment quickly, which is essential to increase her chances of survival. If detected and treated early, the five-year survival rate is more than 90 percent. But if the cancer has already spread, that rate drops to about 12 percent
The vaccine targets a protein called α-lactalbumin, which is only found in the body when a woman is breastfeeding or during the formation of breast cancer. The vaccine trains the immune system to destroy cells that make that protein, meaning that when cancer cells form, the immune system will destroy them and they will never have the chance to multiply into a tumor.
Dr. Justin Johnson, program manager at Cleveland Clinic Lerner Research Institute, and co-developer of the vaccine, said Yahoo life: ‘The side effects were generally mild and mainly consisted of irritation at the injection sites.
‘Our data to date show that we have generated robust immunity to the alpha-lactalbumin target in the majority of 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 almost 80 percent of cases.
Triple-negative cancer makes up only 10 to 15 percent of all breast cancer cases, but is still responsible for breast cancer an estimated 40 percent of deaths because of breast cancer.
Mrs Davis said: “I didn’t know much about it when I was diagnosed, but when you go through it all you learn so much. It’s just that kind of breast cancer – that specific type – I can’t take it anymore afterward, no tamoxifen (a form of hormone therapy), and the recurrence is high.
“If it comes back, the results won’t be the best.”
Women who start treatment in the early stages of the disease have an average of about 91 percent likely as women who do not have this cancer can live at least five years after diagnosis.
But if the cancer has spread elsewhere through the body, such as to the lungs, bones or liver, that survival rate drops to just 12 percent.
So far, none of the 15 women who initially participated in the study have seen their cancer return.
Dr. Amit Kumar, CEO of Anixa Biosciences, the company developing the vaccine, told DailyMail.com this summer: ‘We could eliminate breast cancer as a disease, just as we eliminated polio and smallpox.
‘We think within five years it will be on the market for people like Jenni, who has had breast cancer and is worried about a recurrence. A few years later it should be available to all women, including those who have never had breast cancer. It’s very exciting.’
For her part, Ms. Davis said she was happy to be part of the effort to hopefully eradicate this type of breast cancer completely.