Gastrointestinal and Cardiovascular Safety Profiles of Neratinib Monotherapy in Patients with Advanced ErbB2-Positive Breast Cancer.:

Background: In a phase 2 study, oral neratinib was administered to patients (pts) with advanced breast cancer in 2 cohorts, those with prior trastuzumab treatment (prior T, n=66) and those with no prior trastuzumab treatment (no prior T, n=70). Neratinib demonstrated robust antitumor activity with objective response rates of 26% and 51%, respectively, and was generally tolerable (Burstein et al. Cancer Res 2009;69:72S). Diarrhea, all grades, occurred in 89% of total pts. Characteristics of the diarrhea and left ventricular ejection fraction (LVEF) measurements are described. Methods: Pts were required to have ErbB2 gene amplification in tumor tissue as measured by fluorescence in situ hybridization by independent assessment. Serial LVEF measurements were made with a multigated acquisition scan or echocardiogram. Pts were ineligible if baseline LVEF was Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5096.