With the first amendment of the pro

With the first amendment of the protocol dated 5/20/15, the accrual goal was increased to 120 patients and the dosing regimen of loperamide was modified from q4h dosing to tid dosing to increase patient compliance. Patients received loperamide at the following schedule: Initial dose of 4 mg with first dose of neratinib followed by 4mg tid for the first 14 days (Day 1 = 16mg/day; Days 2-14 = 12 mg/day). After the first 14 days, loperamide 4mg bid through the first 2 cycles of therapy (Days 15-56) from start of neratinib. There have been two additional amendments. Amendment #3 on 3/24/16 in which the protocol added the anti-inflammatory, budesonide, to the regimen and Amendment #4 on 8/19/16 which added the bile-acid sequestrant, colestipol, to the regimen.