CLEVELAND — Every year, more than 300,000 women across the United States are diagnosed with breast cancer. About 15% of those cases are triple-negative—the most aggressive and deadly form of the disease. At the Cleveland Clinic, researchers are testing a preventive vaccine, and results from Phase 1 of the trial are showing promising signs.
Sherie Steinberger was diagnosed with triple-negative breast cancer in 2020.
“I went through the chemo. I ended up having a lumpectomy and then six months of chemo medication. And I am one of the very, very lucky,” said Steinberger.
By the end of 2021, she was cancer-free. That milestone was followed by another unexpected call—this one offering hope.
“She said, ‘We’ve chosen you for the trial.’ So I said, ‘Well, you have to wait, because I have to call my oncologist. He saved my life, so whatever he says, that’s what I do.’ And he called me back and told me on the phone that I had won the golden ticket,” Steinberger said.
After beating breast cancer, Steinberger became one of 35 women who participated in a three-year clinical trial at the Cleveland Clinic for a preventive breast cancer vaccine.
“I kept praying, ‘Oh, I hope this works,’ not just for me, but for everyone else out there that goes through it,” she said.
Justin Johnson, a researcher on the trial, says the vaccine was safe and triggered an immune response in 74% of participants.
“About three quarters of the women in the trial had a strong immune response to the vaccine. So that doesn't guarantee that the vaccine is going to work in preventing cancer, but it's a very good sign that it can,” said Johnson.
Participants fell into one of three categories: women previously treated for triple-negative breast cancer, cancer-free individuals at high genetic risk, and patients with residual cancer after treatment.
“So each woman got a series of three shots. They were one week apart and placed in different areas in her, on her body, under the skin,” said Johnson.
Most participants experienced only mild side effects, such as skin irritation at the injection site.
“The purpose of phase one was to establish safety and determine an optimal dose, and we're very excited that we did both of those things, and now we need to test efficacy,” said Johnson.
The vaccine targets a lactation protein not found in healthy, aging breast tissue but present in most triple-negative breast cancers. It is the result of decades of research at the Cleveland Clinic.
Phase 2 of the trial is expected to begin next year. For Steinberger, she says she’s honored to be part of moving breast cancer research forward.
“It makes me want to cry with joy. It's it truly is a miracle, and research is more important, probably than I ever realized for everyone around the world. The research that these doctors do to try to cure different diseases and illnesses, but this vaccine itself, it's a miracle,” said Steinberger.
Phase 2 of the trial will focus on how well the vaccine works.
