Preventive Breast Cancer Vaccine Trial Moves into Next Phase

CLEVELAND – A vaccine designed to prevent breast cancer is moving into the next phase of study.

Cleveland Clinic researchers will soon begin enrolling for phase 1b.

“We now have a good idea of the dose range that we need to study,” said G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study. “Now we’re expanding, meaning increasing accrual to some of these dose levels, to get an idea of the shape of the immune response according to dose and time. So, that’s where we are with Phase 1a. But we do have an idea of the doses that we should study, so we’re opening it up to Phase 1b.”

Dr. Budd said the main difference between phase 1a and phase 1b is participants.

Phase 1a is studying the vaccine in people who have had and have been treated for triple-negative breast cancer but are at risk for recurrence.

Phase 1b will be open to individuals who have never had breast cancer, but are at high risk due to genetics and are planning to have a preventive mastectomy.

In this group, Dr. Budd said researchers will continue to evaluate safety, fine-tune dosage, monitor immune response through blood tests and also look for side-effects by studying post-mastectomy breast tissue.

He said the research is coming along, but it will be years before they know if the vaccine works.

“The ultimate goal of this research trial is to develop a vaccine that could prevent breast cancer in people who are at risk,” explained Dr. Budd. “It’s a lofty goal, but that would be what we would hope for. There are a lot of steps to go through before that. This may not work, but you know it’s one of those journeys of 1,000 steps that has to start. So we’re taking the first steps.”

Researchers expect to have results from this early phase of research by the end of 2023.