The Cleveland Clinic has launched a Phase I trial for what could be the world's first vaccine to prevent triple-negative breast cancer.
The trial will look at the maximum dose of the vaccine that may be tolerated in patients with early-stage triple-negative breast cancer in order to optimize the body's immunological response.
The decision to proceed with the study follows the U.S. Food and Drug Administration's approval of its Investigational New Drug (IND) application, which allows Cleveland Clinic and its partner, Anixa Biosciences, to proceed.
The Phase I trial, which is being funded by the U.S. Department of Defense, will look at 18 to 24 patients who have had therapy for early-stage triple-negative breast cancer in the last few years and have been classified as tumor-free but at high risk of recurrence. Participants will be given three doses of the vaccine, two weeks apart.
Triple-negative breast cancer accounts for only about 10% to 15% of all breast cancer cases. It does, however, have a high mortality rate and recurrence rate.
The vaccine is intended to target α-lactalbumin, a breast-specific lactation protein that remains high in illness patients but should be gone as tissues mature. Scientists believe that by activating the immune system against this sort of protein, cancers that express it can be prevented from forming.
Aside from this experiment, the researchers are planning another one using the same vaccine, with people who are healthy and have never had breast cancer but are at risk of acquiring it and have had an elective mastectomy to lower their risk.
These participants typically have BRCA1 or BRCA2 gene mutations, which predispose them to triple-negative breast cancer or any other type of breast cancer.
"Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers," Vincent Tuohy, the primary inventor of the vaccine and immunologist at the Lerner Research Institute of the Cleveland Clinic, said in a statement.
"If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had."
Tuohy also stated that the same vaccine could potentially be used to treat other cancers.
The Phase I trial is based on Dr. Tuohy's pre-clinical research, which showed a positive immune response in mouse models. In mice, the same study discovered that a single immunization could prevent breast cancers and slow the growth of existing ones.
Cleveland Clinic hopes to complete the study by September 2022.
The details of this study are published in Nature Medicine.
