- According to the WHO, around one in 12 women will develop breast cancer in their lifetime.
- The vaccine was created to prevent triple negative breast cancer, that is, the most aggressive and lethal form of this disease.
- Funded by the US Department of Defense, the new phase 1b study will enroll cancer-free people at high risk of developing this tumor who have chosen to voluntarily undergo a prophylactic mastectomy to reduce their risk.
Immunization remains one of the greatest inventions in history. Since its development, a large number of diseases have been eradicated. Despite all the efforts, there are still some pathologies for which biologics have not been created. Therefore, it has been of great importance the first breast cancer vaccine in history, but does it really work?
By way of context it is necessary to mention that in 1749 the scientist Edward Jenner was the creator of vaccines. Over the years, his invention has gained great relevance. To put in context, it is currently estimated that immunizations prevent between two and three million deaths each year.
For its part, in recent years several diseases have been eradicated or are about to be eradicated thanks to immunizations. Only in the United States during 2020 were not reported cases of smallpox or poliomyelitis. This is one of the greatest advances achieved in the nation because the annual average during the 20th century was 29,005 and 16,316 cases, respectively.
Testimony of the woman who received the first vaccine against breast cancer
Back in the present, there is a woman who has made history because it is the first to receive the breast cancer vaccine. His name is Jennifer Davis and from one moment to the next his life changed completely.
First, the mother of three children was diagnosed with triple negative breast cancer. At that moment he thought the worst because he didn’t know how he was going to tell his family. After receiving her diagnosis, Jennifer knew that she wanted to take advantage of all available treatment options. Through her driven search for answers she became the first person to participate in a new study at Cleveland Clinic.
“When I found out that I was the first person to receive the vaccine, I was very excited. The trial has given me a lot of hope,” says Jennifer, a registered nurse from Lisbon, Ohio.
Jennifer’s health journey began in February 2018 when she felt a lump in her breast. She went to a local hospital for follow up and the first biopsy on her showed no evidence of cancer. Months passed and Jennifer says the lump has grown.
She listened to his body and continued to check on him until he finally received another biopsy after the doctors detected abnormalities during an ultrasound. His diagnosis was confirmed about a week later, and he sought a second opinion for his treatment.
“I knew I wanted to go to the Cleveland Clinic, so I had my first appointment there shortly after. I met my entire care team at my first appointments and had a complete treatment plan. I was very happy with my team and was looking forward to getting started.”
As part of the plan, he underwent multiple rounds of chemotherapy and radiation. She also had a double mastectomy performed by breast surgeon Zahraa AlHilli, MD.
“After the double mastectomy, I was adamant while in recovery about wanting to know what they found and if the cancer had spread. Dr. AlHilli was able to get clear margins, and there were no signs that the cancer had spread anywhere else.”
After undergoing treatment, it was during her follow-up appointments with breast medical oncologist Megan Kruse that she learned about the clinical trial of the breast cancer vaccine.
How does the first breast cancer vaccine in history work?
The vaccine is based on preclinical research led by the late Vincent Tuohy, PhD, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at the Lerner Research Institute of Cleveland Clinic.
The vaccine targets a lactation protein called α-lactalbumin, which is no longer found after lactation in normal and aged tissues, but is present in most triple-negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and prevent it from growing.
“Triple negative breast cancer is the form of the disease for which we have the least effective treatments. In the long term, we hope that this could be a true preventative vaccine given to cancer-free people to prevent them from developing this highly aggressive disease.”
Jennifer is participating in the Phase 1a study, which includes patients who have completed treatment for the triple negative breast cancer early stage within the past three years and are currently tumor free but at high risk of recurrence.
“I don’t take any medication to make sure there isn’t a recurrence. With every pain and pain, your mind goes to the worst. So, I was very excited when I heard about the vaccine,” Jennifer says.
In October 2021, the young woman became the first patient to enroll in the trial and receive the first dose of the vaccine.
Over the course of the study, Jennifer and other participants received three doses of the vaccine. They were administered two weeks apart, and participants were closely monitored for side effects and immune response. She received her last dose of it in November 2021 and has not noticed any major side effects.
“My husband accompanied me for the first vaccination. Then my mom joined me for the second and third. I don’t know if I ever went to an appointment at Cleveland Clinic alone, and that support has meant a lot to me.”
In February 2023, Cleveland Clinic researchers launched the next step in their study of the vaccine. The Phase 1b clinical trial, conducted in association with Anixa Biosciences, Inc., focuses on individuals who are cancer-free, at high risk of developing breast cancer, and have chosen to voluntarily undergo a prophylactic mastectomy to reduce their risk.
Meanwhile, Jennifer, now 46, continues to follow up with Dr. Kruse as she approaches her fifth year of remission. Although it will take years for her to fully understand the effectiveness of the vaccine, she is looking forward to what is to come and hopes that her story can help others diagnosed with breast cancer.
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