IU School of Medicine researcher Dr. Bryan Schneider is leading a new nationwide clinical trial to improve cure rates for patients with triple-negative breast cancer.
PERSEVERE, a phase 2 clinical trial, is designed to better understand the effectiveness of personalized cancer treatments based on patients’ genetic makeup.
Schneider, an oncology professor, said triple-negative breast cancer is highly aggressive and accounts for about 20% of patients with breast cancer. Two-thirds of triple-negative breast cancer patients still have cancer cells after chemotherapy and surgery, he said.
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Schneider said PERSEVERE focuses on this group of patients who have a high risk of relapse and a low cure rate.
“The patient's just undergone chemotherapy, just undergone surgery, and then they meet back with their doctor to be told ‘you have a flip of the coin chance of this cancer coming back and ultimately claiming your life,’” Schneider said. “And so this is a population that we have focused a lot of our clinical trial activity on.”
Jenny Brown, a participant of a previous triple-negative breast cancer clinical trial at the School of Medicine, said clinical trials like PERSEVERE can change the lives of patients.
Before Brown’s clinical trial in 2019, she was out of options to cure her rare combination of stage four triple-negative and inflammatory breast cancers.
“I remember my oncologist held my hand and looked me in the eye and said there were no approved treatment options available for me,” Brown said. “She gave me an estimated 12 to 18 months to survive. That’s just an unreal moment.”
But after being invited to participate in IU’s clinical trial, Brown said she experienced a “miraculous” recovery. She’s been off all cancer drugs for 18 months now and has no signs of active disease.
Brown said IU’s innovative breast cancer research made her recovery possible.
A previous study by Schneider and colleagues at IU Melvin and Bren Simon Comprehensive Cancer Center discovered that the presence of cancer tumor DNA in patients’ bloodstream (ctDNA) can determine the risk of relapse for these patients. This study led to PERSEVERE, which will use a noninvasive technique to test participants for ctDNA and predict their risk of relapse.
Schneider said PERSEVERE will enroll about 200 patients at 20 different sites across the U.S. over the next two to three years. The trial enrolled its first patient this October, he said.
Participants identified to have ctDNA will then be treated with targeted drugs based on the genetic makeup of their tumor, Schneider said. Those without ctDNA will receive standard treatment.
“What we're really doing here is using a lot of cutting edge technology and a lot of emerging, really personalized and targeted therapies to try to better fit our therapies for each patient based on the blueprint of their tumor, which I think is a really cool and innovative approach to trials,” he said.
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Schneider said the ultimate goal of PERSEVERE, and all medical research at IU, is to improve patient outcomes.
Xiongbin Lu, a School of Medicine professor and cancer biologist, conducts pre-clinical trial research on triple-negative breast cancer. Lu said he conducts foundational research to develop cancer treatments, which can then be used in studies like PERSEVERE to improve patient outcomes and advance cancer research.
“Something that we always need to keep in mind is helping patients,” Lu said. “I think that’s why these studies are so important. They can translate all the basic research into real clinical applications.”
Brown said she now hopes to encourage other cancer patients to participate in clinical trials.
“We're just really lucky at IU to have faculty and physicians who embrace the research and really work hard to get as many patients involved in clinical trials that are eligible,” Brown said. “I'm a living, walking testament to the fact that they can absolutely extend life in unexpected ways.”
