RT Journal Article
SR Electronic
A1 Cunningham, Muriel
T1 Results From the EPO-ANE-3010 Study Consistent With US Black Box Labeling
JF MD Conference Express
YR 2014
FD SAGE Publications
VO 14
IS 56
SP 12
OP 12
DO 10.1177/1559897715571063
UL http://mdc.sagepub.com/content/14/56/12.abstract
AB The phase 3, randomized, noninferiority EPO-ANE-3010 study was conducted, at the request of the United States Food and Drug Administration, in 2098 patients with metastatic breast cancer, to address safety concerns regarding erythropoiesis-stimulating agents. Compared with standard supportive care, epoetin alfa treatment did not meet the protocol-defined noninferiority criteria.