CLEVELAND (WJW) — Cleveland Clinic researchers have launched the next stage of their study of a preventative breast cancer vaccine.
This new vaccine aims to prevent triple-negative breast cancer, the most aggressive and deadly form of the disease, according to a press release from the Cleveland Clinic.
“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” said G. Thomas Budd, MD, of the Cleveland Clinic’s Taussig Cancer Institute and the study’s principal investigator. “In the long term, we hope this will be a real preventive vaccine that would be given to people without cancer to prevent them from developing this very aggressive disease.
The new phase 1b study will recruit people without cancer at high risk of developing breast cancer who have decided to voluntarily undergo a prophylactic mastectomy to reduce their risk.
This category of people usually carry genetic mutations that put them at risk of developing triple-negative breast cancer or have a high familial risk of breast cancer, the statement said.
The phase 1b clinical trial follows the ongoing phase 1a study, which began in 2021 and is expected to be completed by the end of 2023.
The Phase 1a trial includes patients who have completed treatment for early-stage triple-negative breast cancer within the last three years and who are currently tumor-free but at high risk of recurrence.
The study, conducted at the main campus of the Cleveland Clinic, will assess the safety of the vaccine and monitor the immune response, according to the release.
The new study will include approximately six to 12 patients and is expected to be completed by the end of 2023.
This Cleveland Clinic study is funded by the US Department of Defense and conducted in partnership with Anixa Biosciences, Inc.
According to Dr. Budd, there is a great need for improved treatments for triple-negative breast cancer, which lacks biological characteristics that typically respond to hormonal or targeted therapies.
Although it accounts for only about 12-15% of all breast cancers, triple negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths. It is twice as likely to occur in black women, and about 70 to 80 percent of breast tumors that occur in women with BRCA1 gene mutations are triple-negative breast cancers, according to the statement.
For more information and eligibility requirements, visit clinicaltrials.gov.