Patient Advocacy Brings Breast Cancer Vaccine to Phase 1 Trial
At the 2025 San Antonio Breast Cancer Symposium (SABCS 2025), Karissa Britten, MD, of Cedars-Sinai, spoke with breast cancer survivor, Judy Fitzgerald, who shared how her breast cancer treatment journey led her to become a patient advocate for breast cancer research.
Shortly after completing therapy for her breast cancer, Ms. Fitzgerald saw a video of Vincent Tuohy, PhD, of the Cleveland Clinic, discussing his attempts to secure funding from Congress for further trials on his preventative vaccine for breast cancer. “I was just shocked, I had just been through a year that I wouldn’t wish on anyone, and I thought, ‘If we can prevent this disease, why is it so hard for this doctor to get the money?’” Ms. Fitzgerald said.
Ms. Fitzgerald contacted Dr. Tuohy and asked how she could help. Partnering with Dr. Tuohy, she began raising awareness and funds for breast cancer vaccine research. Eventually, Ms. Fitzgerald founded Sisters4Prevention to grow her advocacy and provide resources for breast cancer patients and survivors. Ms. Fitzgerald’s journal and notes from during her treatment also formed the basis for her book, A Teacher’s Journey… What Breast Cancer Taught Me, the proceeds from which support the research effort.
The breast cancer vaccine targets the milk protein alpha-lactalbumin (aLA), which is usually only expressed by lactating breast tissue, but is also aberrantly expressed in approximately 70% of triple-negative breast cancer (TNBC). In 2019, a grant from the Congressionally Directed Medical Research Programs brought the vaccine to a phase 1 safety and dose-finding trial. Early results from the trial, presented at SABCS 2025, established a maximum tolerated dose and reported that 19 of 26 patients across 3 TNBC cohorts showed evidence of an immune response to recombinant aLA. Data from the trial will inform the design of phase 2 trials.