49
Participants
Start Date
August 31, 2014
Primary Completion Date
December 31, 2020
Study Completion Date
August 31, 2021
Neratinib
"Dose-Escalation Phase (Part 1) - Neratinib Dose-escalation will proceed on the basis of DLT during Cycle 1 starting at 120 mg/day.~Dose level 1: 120 mg/day; Dose level 2: 160 mg/day; Dose level 3: 200 mg/day; Dose level 4: 240 mg/day~Dose-evaluation Phase (Part 2) - Patients will receive the highest dose of neratinib with T-DM1 found in Phase I as study therapy"
T-DM1
"Dose-Escalation Phase (Part 1) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days.~Dose-evaluation Phase (Part 2) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days."
UPMC- Hillman Cancer Center-Monroeville, Monroeville
Alleheny General Hospital, Pittsburgh
Hillman Cancer Center, Pittsburgh
Magee Womens Hospital of UPMC, Pittsburgh
University of Pittsburgh, Pittsburgh
UPMC- St. Margaret, Pittsburgh
UPMC Hillman Cancer Center North Hills at Passavant, Pittsburgh
West Virginia University, Morgantown
Cleveland Clinic Weston, Weston
Cleveland Clinic, Cleveland
Cancer Care Specialists of Central Illinois-Swansea, Swansea
Crossroads Cancer Center, Effingham
Cancer Care Specialists of Central Illinois, Decatur
Stephenson Cancer Center at the University of Oklahoma Health Services Center, Oklahoma City
Women & Infants Hospital of Rhode Island, Providence
Puma Biotechnology, Inc.
INDUSTRY
NSABP Foundation Inc
NETWORK