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I-SPY 2 Breast Cancer Clinical Trial Coming To Wake Forest Baptist Health

The I-SPY 2 Breast Cancer trial is available to patients with early-stage, high-risk for recurrence breast cancer.

WINSTON-SALEM, N.C. — An innovative breast cancer clinical trial is coming to Wake Forest Baptist Health. It’s available to patients with early-stage, high-risk for recurrence breast cancer.

It’s called the I-SPY 2 TRIAL. It will allow for every patient’s data to contribute real-time information so that the next similar patient receives the best treatment in the trial.

“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, M.D., professor of hematology and oncology at Wake Forest Baptist Health’s Comprehensive Cancer Center and principal investigator for the Wake Forest Baptist site.

But it also allows for treatment options to be adjusted.

“With this study, data is constantly being analyzed and medications are adjusted throughout the course of the trial, so each patient receives personalized treatment,” said Thomas.

The data will be analyzed and shared with breast cancer physician-scientists at other trial sites. It will also be shared with pharmaceutical and biotechnology companies and patient advocates. Wake Forest Baptist Health will then use it for the next phase of the trial.

The study will help discover which new drugs are most effective with specific types of breast cancer tumors.

Two drugs that will be used in the trial have already received accelerated approval from the FDA and one has gained breakthrough therapy designation from the FDA.

Wake Forest Baptist Health is the only health system in North Carolina to join the study. It’s a collaboration with 20 major cancer research centers, the FDA, the Foundation for the National Institutes of Health Biomarkers Consortium and Quantum Leap Healthcare Collaborative.

Find out how to join the clinical trial, I-SPY 2 TRIAL 


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