By Francis Allan L. Angelo
After undergoing treatment for triple-negative breast cancer, Jennifer Davis, a registered nurse and mother of three from Lisbon, Ohio, U.S., became a recipient of the world’s first-of-its-kind preventative breast cancer vaccine being trialed in a study by the global health system Cleveland Clinic.
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.
This protein is not found in normal, aging tissues after lactation but is present in most triple-negative breast cancers. The vaccine is designed to prompt the immune system to attack the tumor should breast cancer develop, thereby preventing its growth.
G. Thomas Budd, MD, a breast medical oncologist and principal investigator for the breast cancer vaccine trial, says, “Triple-negative breast cancer is the form of the disease for which we have the least effective treatments. Long term, we hope 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. Before joining the trial, Jennifer’s treatment at Cleveland Clinic included chemotherapy, radiation, and a double mastectomy. Fortunately, her medical team found no signs of the cancer spreading to any other part of her body.
“There is no medication I take to ensure there’s no 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 vaccine’s initial dose. “I didn’t think twice about getting the vaccine and haven’t looked back since.”
Breast medical oncologist Megan Kruse, MD, who first mentioned the trial to Jennifer at one of her follow-up appointments, says, “For a long time with triple-negative breast cancer, patients felt as though they were destined to have the cancer return despite all the treatment. I think the hope this vaccine study offers, potentially changing that narrative and bringing optimism for the future of these patients, is the best part.”
Over the course of the study, Jennifer and other participants received three vaccine doses, each two weeks apart. They were closely monitored for side effects and immune responses. She received her last dose in November 2021 and has reported no major side effects.
“My husband accompanied me for the first vaccine, then my mom for the second and third,” says Jennifer. “I don’t think I ever went to an appointment at Cleveland Clinic by myself, and that support has meant so much to me.”
In February 2023, Cleveland Clinic researchers launched the next step in their vaccine study. The phase 1b clinical trial, conducted in partnership with Anixa Biosciences, Inc., focuses on individuals who are cancer-free, at high risk of developing breast cancer, and have decided to undergo a prophylactic mastectomy voluntarily to lower 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 to fully understand the vaccine’s effectiveness, she is hopeful about the future and eager to share her story to help others diagnosed with breast cancer.
“Even though there will be days when you’re not feeling positive, when you feel terrible, keep moving forward,” Jennifer advises. “If the vaccine works as hoped, it could one day prevent triple-negative breast cancer.”
