Cleveland Clinic Enrolls Patients in Breast Cancer Vaccine Trial

The Cleveland Clinic recently announced that it would begin enrolling patients for its phase 1b breast cancer vaccine study. The study will focus on cancer-free patients at risk of developing cancer, using genetic mutations or familial risk as an indicator. Researchers plan to recruit patients who have undergone a voluntary prophylactic mastectomy to reduce the risk of developing cancer. They anticipate that this phase of the study will include up to a dozen patients — with a minimum of six patients — and will conclude at the end of this year.

The initial study, phase 1a, began in 2021 and will close by the end of 2023. Phase 1a studies focused on patients who had and recovered from early-stage triple-negative breast cancer in the past three years.

The vaccine is developed to target α-lactalbumin. According to the news release, this protein — often referred to as the lactation protein — is produced when an individual is lactating or preparing for lactation. However, as lactation concludes and a patient ages, a healthy body stops producing this protein.

Patients with triple-negative breast cancer tend to continue producing this protein as the tumor grows. According to the Cleveland Clinic, approximately 70% of patients with this kind of breast cancer have this biomarker. The adjuvant in the vaccine triggers the body’s immune response in the presence of α-lactalbumin, causing the body to attack the tumor and prevent further spread.

This preventative study follows clinical trials for another breast cancer vaccine conducted at the University of Washington. One key difference is that researchers at the Cleveland Clinic are looking to create a preventative vaccine, while researchers in Washington hope to use vaccines as a treatment method. While both trials are still in the early stages, a successful progression of clinical trials has many implications.

According to the American Cancer Institute (ACS), almost 300,000 people are diagnosed with breast cancer yearly. Furthermore, there are roughly 43,000 breast cancer-related deaths each year. Breast cancer disproportionately impacts Black women and women in other marginalized communities due to systemic and systematic racism in the healthcare system. Outside of addressing these root causes, developing clinical tools such as vaccines to minimize the impacts of delayed treatment can help address this persistent treatment gap.