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New breast cancer trial underway at Cleveland Clinic, targets most aggressive form

Cleveland Clinic
Posted at 7:01 PM, Mar 21, 2022
and last updated 2022-03-21 19:05:26-04

CLEVELAND — Debra Green was diagnosed with stage one breast cancer just before she turned 40.

“I remember clearly the day I was diagnosed, what my doctor said to me, and if women can avoid that diagnosis that would be incredible,” said Green.

Next month marks 27 years since she got that news.

“No one wants to hear those words because once you hear the words you always have this fear, you’re going to hear it again, “said Green.

Now, Cleveland Clinic’s Dr. Vincent Tuohy and a team of doctors and researchers are trying to stop other women from being diagnosed with breast cancer.

Tuohy got the idea for a breast cancer vaccine 20 years ago.

“These tumor cells, they’re like toddlers they don’t pay attention to normal signals. They don’t listen to their parents, so to speak, they wreck the place if you let them,” said Tuohy.

The investigational vaccine targets a lactation protein, which is no longer found in post-lactation normal aging tissue but is found in the majority of triple-negative breast cancers.

“If we aim our immune system and target our immunity against some of these proteins, we believe that we could develop a preemptive immunity that protects women from breast cancer,” said Tuohy.

Doctors said the research shows it’s safe and effective in preventing breast tumors in mice.

The phase one trial is well underway.

It’s designed to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer and to characterize and optimize the body’s immune response.

The U.S. Food and Drug Administration approved an investigational new drug application for the vaccine, which allowed the Cleveland Clinic and Anizia Biosciences, Inc. to start the study.

Funded by the U.S. Department of Defense, the study at Cleveland Clinic includes about 30 patients who have completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.

During the study, participants receive three vaccinations, each two weeks apart, and are being closely monitored for side effects and immune response.

The study is estimated to be completed in September 2022.

Researchers anticipate that a subsequent trial will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo a voluntary bilateral mastectomy to lower their risk.

Typically, those women carry mutations in either the BRCA1 or BRCA2 gene and are therefore at risk of developing triple-negative breast cancer or have a high familial risk for any form of breast cancer.

"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,” said Dr. G. Thomas Budd, Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study. “Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments."

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