Breast cancer vaccine awaiting approval

SAN ANTONIO (KXAN) - After 10 months of chemotherapy, surgeries and radiation, Kelly Trombitas beat breast cancer late last year.  Still, she knew it would be wise to keep fighting it.

“I am considered cancer-free and cured,” said Trombitas. “But I was thinking, ‘God, I hope it doesn’t come back.'”

Her concern was not without merit. Nearly 25 percent of woman who beat breast cancer are forced to face it again.

That percentage is large enough for Trombitas, who is married and has two children, to decide it would be worth the risk to volunteer her cancer-free body in an experiment that is one-step away from a breast cancer breakthrough.

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• Results for other breast cancer trials
• Breast cancer treatment options
• Causes, genetics and prevention

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"When I first got diagnosed, I got on the Internet and read everything I could about breast cancer,” said Trombitas. “And (the experts) said if you can get into a clinical trial, then do it.”

That is why Trombitas was back in a hospital room in January at the San Antonio Military Medical Center. Only this time, she was being inoculated with a vaccine doctors hope will validate more than 10 years of work.

“We have been working in this area for a long time,” said Dr. George Peoples, the director of cancer vaccine development at the military medical center. “It is not a new area, just an area that has begun to show some success."

According to the National Cancer Institute, more than 230,000 cases of breast cancer are diagnosed in a year. The disease claims about 39,500 lives a year.

The success Peoples mentions is with a vaccine many believe will cut the reccurrence rate of breast cancer from 25 percent to around 10 percent.

“This trial is almost a decade in the making,” said Peoples, an Army colonel who was referring to the third and final phase the vaccine must pass in order to get approval from the U.S. Food and Drug Administration.

Phase 1 proves a vaccine is safe, Phase 2 proves it is effective and now 700 to 1,000 women at risk for a breast cancer recurrence are expected to take part in Phase 3 of the trial.

Trombitas was the first patient inoculated in the final phase.

“I didn’t know it would be such a significant event,” she said. “I love being here because everyone is so excited about it."

The vaccine was developed in an attempt to use a patient's own immune system to help fight the cancer.

“Once we can prove the immune system can recognize and kill a cancer cell, the question becomes ‘How did it do that?'” said Peoples. 

Once those questions are answered for recurrence, it will be a big step towards preventing the cancer from the start.

“Ultimately, we would like to use a breast cancer vaccine to prevent," he said. "But we are not there yet.”

Even FDA approval will be a test in patience. That means Trombitas and others in the program will be followed for as long as five years to see how effective the vaccine is in preventing a cancer comeback.

If the results of the final trial are as promising as they were in the previous trials, the data will be presented to the FDA for approval.

“To be that close to prevent recurrence is awesome,” said Trombitas just moments after nurses gave her a series of shots.

She admitted to being nervous, but hopes the payoff will keep the cancer away from her and thousands of others.

“I did not hesitate at all to be part of it. This study is going to help future people and it is amazing how many people have breast cancer," she said.