03/15/2016 08:00 PM EDT
Phase III cancer clinical trials almost always compare a new treatment with the existing standard of care. With science moving so rapidly, research results sometimes outrace a trial’s design and the trial has to be recalibrated to include newer treatments. One current example of this need for trial redesign is a recently opened NCI-sponsored clinical trial led by the ECOG-ACRIN Cancer Research Group, called EA1131, for women with triple-negative breast cancer, a subtype of breast cancer that is notoriously difficult to treat. Women in the trial must have had chemotherapy before surgery—known as neoadjuvant chemotherapy—but still have some evidence of cancer in their breast or lymph nodes at the time of surgery (residual disease). Under the trial’s initial design, after surgery, patients were to be randomly assigned to receive either adjuvant therapy with a platinum chemotherapy drug or no additional therapy, which was the standard of care when the trial opened in May 2015.