The trial is a randomized, open-label, multi-center trial designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without Efaproxyn in women with breast cancer that has spread to the brain.
This interim review was triggered by the occurrence of 94 patient deaths. No major patient safety concerns were identified by the data monitoring committee (DMC). The trial is expected to enroll 360 patients at up to 125 sites worldwide. The primary endpoint of the trial is survival.
“This recommendation represents continued progress toward the completion of patient enrollment in Enrich (the trial) and further validation of Efaproxyn’s favorable safety profile,” said Paul Berns, president and chief executive officer of Allos. “We are pleased with the DMC’s recommendation and are grateful for the support received from investigators and patients who enabled us to reach this milestone.”