First Patient to Receive Breast Cancer Vaccine Shares Health Journey

During a typical day at work, Jennifer Davis received an unexpected call that changed her life. A nurse on the other end of the line delivered the news Jennifer had triple-negative breast cancer. The mother of three recalls feeling terrified. She didn’t know how she was going to tell her family. After receiving the diagnosis, Jennifer knew she wanted to take advantage of every treatment option available. Through her driven search for answers, she became the first person to participate in a novel study at Cleveland Clinic for a vaccine that aims to eventually prevent triple-negative breast cancer.

“When I found out I was the first person to receive the vaccine, I was excited. I was thrilled. The trial has given me a lot of hope,” says Jennifer, a registered nurse from Lisbon, Ohio.

Jennifer’s health journey started in February 2018 when she felt a lump in her breast. She went to a local hospital for follow-up, and her first biopsy showed no evidence of cancer. Months went by, and Jennifer says the lump grew. She listened to her body and continued to get it checked. Jennifer eventually received another biopsy after doctors detected abnormalities during an ultrasound. Her diagnosis was confirmed about one week later, and she sought a second opinion for her treatment.

“I knew I wanted to go to Cleveland Clinic, so I had my first appointment there shortly after. I met my entire care team within my first few appointments and had a complete treatment plan. I was very happy with my team and was anxious to get started,” says Jennifer.

As part of the plan, she 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 whether the cancer had spread. Dr. AlHilli was able to get clear margins, and there were no signs the cancer had spread anywhere else,” says Jennifer.

After undergoing treatment, it was during her follow-up appointments with breast medical oncologist Megan Kruse, MD, she learned about the breast cancer vaccine clinical trial.

The vaccine is based on pre-clinical research led by the late Vincent Tuohy, PhD, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic’s Lerner Research Institute. The vaccine targets a lactation protein called α-lactalbumin, which is no longer found after lactation in normal, aging 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 keep it from growing.

“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” said G. Thomas Budd, MD, breast medical oncologist and principal investigator for the breast cancer vaccine trial. “Long term, we are hoping this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease.”

Jennifer is involved in phase 1a of the study, which includes patients who completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.

“There is no medication I take to make sure there’s not a recurrence,” says Jennifer. “With every ache and pain, your mind goes to the worst-case scenario. So, I was very excited when I heard about the vaccine.”

In October 2021, Jennifer became the first patient to enroll in the trial and receive the first dose of the vaccine. “I didn’t think twice about getting the vaccine and haven’t looked back since.”

Dr. Kruse says, “For a long time with triple-negative breast cancer, the overarching theme patients talked about is how they’re going through all this treatment but still feeling like they’re destined to have the cancer return. I think having the hope of this vaccine study where we can potentially turn that around and have some optimism as we approach the future for these patients is the best part.”

Over the course of the study, Jennifer and other participants received three doses of the vaccine. The vaccinations were each given two weeks apart, and the participants were closely monitored for side effects and immune response. She received her last dose in November 2021 and has not noted any major side effects.

“My husband went with me for the first vaccine. Then my mom went with me for the second and third,” says Jennifer. “I don't know if I ever went to an appointment at Cleveland Clinic by myself, 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 partnership with Anixa Biosciences, Inc., focuses on individuals who are cancer-free, at high risk for developing breast cancer and have decided to voluntarily undergo a prophylactic mastectomy to lower their risk.

Meanwhile, Jennifer, now 46 years old, continues to follow up with Dr. Kruse as she nears her fifth year of being in remission. Although it will take years to fully understand the vaccine’s effectiveness, she’s eager for what’s to come and hopes her story can help others diagnosed with breast cancer.

“Even though you’re going to have days where you’re not positive, where you feel terrible – keep moving forward. If the vaccine works the way they want, it could prevent triple-negative breast cancer one day," says Jennifer.

Editor's note: Dr. Tuohy was inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. He was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in the company.