A new next-generation clinical trial for breast cancer is now enrolling patients at UNC Lineberger Comprehensive Cancer Center. The new trial, called EVOLVE, aims to transform treatment for metastatic breast cancer by using real-time data to match patients with the most effective therapies as their tumors evolve.
Lisa Carey, MD, ScM, FASCO, the L. Richardson and Marilyn Jacobs Preyer Distinguished Professor for Breast Cancer Research at the UNC School of Medicine and the deputy director of clinical sciences at UNC Lineberger, is the study's lead investigator.
"By moving beyond traditional, static trial designs and fostering open collaboration among researchers and clinicians, this effort seeks to accelerate discovery, improve outcomes, and bring more personalized cancer care to patients faster than ever before," said Carey.
Lisa Carey, MD
The clinical trial will enroll five hundred patients with breast cancer across fifteen sites across the United States, including Dana-Farber Cancer Institute, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, and more.
Eligible participants include patients with ER+/HER2- or triple-negative metastatic breast cancer who have progressed on their first type of treatment after the diagnosis of metastatic disease but have not yet initiated the second treatment.
Patients will be divided into precision medicine-driven treatment arms that adapt based on how each cancer responds over time. Using tumor biopsies, blood samples, high-resolution imaging and medical records, researchers will be able to monitor changes in a patient's cancer.
They'll also study circulating fragments of tumor DNA found in the blood and other circulating biomarkers to learn how to identify treatable signs of treatment resistance, guiding the researchers towards the use of other endocrine, targeted, and combination therapies as resistance emerges.
The EVOLVE trial is backed by the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services. UNC is leading the trial on behalf of the Translational Breast Cancer Research Consortium (TBCRC), a national network of leading academic cancer centers.
The trial is one of ten projects under ARPA-H's Advanced Analysis for Precision Cancer Therapy (ADAPT) program. Bringing together experts in biology, data science and oncology, ADAPT aims to address the challenge of treating metastatic breast, lung, or colon cancer, which often changes and becomes resistant to treatment.
"Treating cancer rapidly and effectively is the best way to save lives - and ADAPT will give clinicians the tools to act nimbly and finally get ahead of stubborn, treatment-resistant tumors," said Alicia Jackson, PhD, director of ARPA-H. "This revolutionary approach to cancer trials has the potential not just to save time and money on ineffective treatments, but to give patients something far more valuable: the chance to restore health and save lives."
The ADAPT program has three primary goals: developing tools that combine diverse patient data, modeling treatment resistance and identifying markers that predict drug response; designing adaptive clinical trials that adjust treatment as cancer evolves; and building a shared platform for researchers and doctors to collaborate using real-time data.
Other principal investigators on the innovative trial include Charles Perou, PhD, an expert on cancer genetics and bioinformatics, and Naim Rashid, PhD, an expert on genomics and statistics, at UNC Lineberger. Ian Krop, MD, PhD, and Eric Winer, MD, of the Yale Cancer Center and Antonio Wolff, MD, of the Johns Hopkins Kimmel Comprehensive Cancer Center, are also principal investigators in the innovative trial.
