A clinical research trial with a unique approach is now available to patients with early stage, high-risk for recurrence breast cancer.
“Most cancer clinical trials collect data from study participants over the course of several years, both during and after treatment, then publish research findings, but that is a long time for clinicians and patients to wait,” said Alexandra Thomas, MD, professor of hematology and oncology at Wake Forest Baptist Health’s Comprehensive Cancer Center and principal investigator for the Wake Forest Baptist site. “With this study, data is constantly being analyzed and medications are adjusted throughout the course of the trial so each patient receives personalized treatment.”
Wake Forest Baptist Health is the only health system in North Carolina to join this study which is a collaborative effort among 20 major cancer research centers, the FDA, the Foundation for the National Institutes of Health Biomarkers Consortium and Quantum Leap Healthcare Collaborative.
The I-SPY 2 TRIAL features an innovative adaptive statistical design in which every patient’s data contributes real-time information so that the next similar patient receives the best treatment in the trial. The data is analyzed and shared with breast cancer physician scientists at other trial sites, pharmaceutical and biotechnology companies and patient advocates, and then used to develop the next phase of the trial. More than 50 clinicians are actively engaged in conducting this trial.
The purpose is to further advance the ability to practice personalized medicine by discovering which new drugs are most effective with specific types of breast cancer tumors and by learning more about which early response indicators are predictive of treatment success.
“I believe this unique approach represents the future of clinical trials and we are honored to collaborate with our colleagues around the country to potentially offer the most promising therapies in breast oncology to our patients and to help accelerate the development and delivery of more effective therapies,” Thomas said.
To date, two drugs used in this trial have received accelerated approval from the FDA and one has gained breakthrough therapy designation from the FDA. This process is designed to expedite the development and review process for drugs which may demonstrate substantial improvement over available therapies.
“This trial was a direct result of having spent much of my career trying to improve the outcomes of women with these early stage, and potentially curable, aggressive breast cancers,” said Laura Esserman, MD, founder and co-principal investigator of I-SPY 2 and director of the Carol Franc Buck Breast Care Center at University of California, San Francisco. “Introducing new therapies before surgery allows us to use early endpoints for assessing response to predict outcomes, and biomarkers to subtype patients and personalize therapies.”
I-SPY 2 TRIAL is sponsored by Quantum Leap Healthcare Collaborative, a 501(c)(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Quantum Leap Healthcare Collaborative provides operational, financial and regulatory oversight of the trial.
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