BCRF Support Helps Investigator Launch Trial for Vaccine to Prevent Breast Cancer

Says BCRF investigator Dr. Olivera Finn: “Without BCRF support, there would be no trial today.”

For more than three decades, Dr. Olivera Finn has pursued what some might call the holy grail of cancer research: a prevention vaccine. And now, thanks to pivotal BCRF funding, she’s testing one in a breast cancer clinical trial.

“Without BCRF support, there would be no trial today,” Dr. Finn said.

Earlier this year, Dr. Finn and her team at the University of Pittsburgh School of Medicine and UPMC Hillman Cancer Center launched a phase 2 clinical trial testing the first breast cancer vaccine designed to train the immune system to target ductal carcinoma in situ (DCIS) cells before they progress into invasive cancer cells.

Dr. Finn initially planned to launch this clinical trial with a $100,000 grant from the Pittsburgh-based A Glimmer of Hope Foundation—but she knew she needed to promptly secure more funding to enroll more than a few patients. That’s when BCRF invited her to apply for funding through its Precision Prevention Initiative, ultimately awarding her a $2.1 million grant. 

“The opportunity to apply came at precisely the right time, and the money came very fast so we could launch—for clinical trials that is crucial,” she said. “We would still be looking for funding otherwise.”

While DCIS—also known as stage 0 breast cancer—is non-invasive and considered precancerous, if left untreated, it can develop into invasive breast cancer in an estimated 20 to 50 percent of cases. More than 51,000 women are diagnosed with DCIS each year.

Today, when a woman is diagnosed with DCIS, she’s typically treated as though she has stage 1 breast cancer: with a lumpectomy and radiation, plus hormone therapy for women with hormone receptor–positive DCIS. About 98 percent of women treated for DCIS are alive 10 years later, so stage 0 breast cancer has an excellent prognosis.

But DCIS treatment is controversial: An estimated 50 to 80 percent of DCIS diagnoses never become invasive breast cancer, so many women undergo unnecessary overtreatment every year. A vaccine like the one Dr. Finn developed could drastically reduce such overtreatment and prevent the disease entirely in women whose DCIS would have become invasive otherwise.

In this phase 1 trial, patients are getting the vaccine along with standard-of-care surgery. If the results from this trial show that the vaccine is strongly immunogenic, Dr. Finn hopes a future trial will test the vaccine in lieu of surgery, to see if a woman’s own immune system, strengthened by the vaccine, could eliminate DCIS and prevent progression to breast cancer.

The vaccine Dr. Finn developed trains the immune system to target an abnormal version of the MUC1 protein (called the MUC1 antigen) that’s produced by cells of more than 80 percent of cancers, including breast. Dr. Finn first discovered that the human immune system could recognize this MUC1 antigen more than 30 years ago, and knowing its potential for prevention, has pursued this research since.

“We published on MUC1 in 1989, and we went into clinical trials in 1993, four years later. Everybody was eager,” she said. “But we were not getting the results we wanted in patients with advanced cancer even though we were getting good results in laboratory models.”

Still, Dr. Finn and her team kept working at it, and their persistence started to pay off. In the early 2000s, they launched the first clinical trial testing of the MUC1 vaccine in people who had a history of advanced adenomas: colorectal polyps that can raise a person’s risk of developing colorectal cancer. When these patients were given the MUC1 vaccine, Dr. Finn reported in 2013, they had a strong immune response and immune memory and were protected from developing new polyps. She continued expanding her research, investigating MUC1 in several cancers.

“We kept testing hypotheses and marching forward. And around us there were tremendous developments in other fields and in immunology—new techniques and technologies,” she said. “We were convinced that all the testing we did and all the hypotheses we developed along the way were moving us in the right direction, we just needed the capability to do this right. We could see it on the horizon. And now here we are.”

Dr. Finn noted that funding, especially for prevention research, can be hard to come by and BCRF’s focus on prevention, definitely stands out.

“It’s striking that BCRF is focused on prevention,” she said. “Prevention research is underfunded, but it’s the hope of the world. It’s so important that BCRF recognizes this.”