Breast Cancer Breakthrough: Cleveland Clinic Trials a New Breast Cancer Vaccine


One of the most aggressive and deadliest breast cancers, triple negative breast cancer (TNBC), will meet its match in the form of a current political hot button issue. A vaccine.

TNBC, which accounts for up to 15% of all breast cancers, is one of the most aggressive types of cancers and generally the prognosis is grim. Common symptoms of TNBC include breast swelling, discharge from the breast, dimpling of the skin, swelling or a lump under the arm or on the collarbone, and skin changes in the area.

Black, Hispanic and younger women are more likely to be diagnosed with the disease. TNBC occurs less in white and Asian women. And up to a whopping 80% of breast tumors that occur in women with the BRCA1 genes are TNBC.

The FDA gave Cleveland Clinic researchers the green light to proceed with a phase I clinical trial for their vaccine. The phase I trial will establish how potent the vaccine dose patients with early-stage triple-negative breast cancer can tolerate, according to a statement by the Cleveland Clinic.

“We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” principal investigator G. Thomas Budd, MD, of the Cleveland Clinic said in the same statement.

The three most common types of receptors known to drive breast cancer growths—estrogen, progesterone and HER-2—are not in the triple-negative breast cancer tumor, which limits treatment options. At present, chemotherapy, radiation and/or surgeries such as lumpectomies and mastectomies are first line treatments but they are not enough to stop or outright prevent the cancer.

“This vaccine approach represents a potential new way to control breast cancer,” inventor of the vaccine and principal investigator Vincent Tuohy, PhD, said in a statement. “The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.”

Funded by the U.S. Department of Defense, the clinical trial will include up to 24 patients who previously completed treatment for early-stage TNBC within the past three years. Research participants should not have tumors but are at high risk for recurrence. Trial enrollees will receive three vaccinations, all two weeks apart and researchers will evaluate their side effects and immune response.

The clinical trial will be completed in September 2022.