36
Participants
Start Date
January 12, 2024
Primary Completion Date
April 30, 2028
Study Completion Date
April 30, 2028
Neratinib
All participants will take 240mg neratinib by mouth every day beginning cycle 1 day 1.
Trastuzumab
All participants will receive standard dosing (6mg/kg loading dose, 4 mg/kg subsequent doses) of Trastuzumab by IV infusion day 1 of each 2 week cycle.
Oxaliplatin
All participants will receive 85mg Oxaliplatin by IV infusion day 1 of each 2 week cycle.
5-Fluorouracil + leucovorin
All participants will receive 400 mg/m\^2 5-Fluorouracil (5FU)+ 400 mg/m\^2 leucovorin day 1 of each 2 week cycle; 5FU continuous infusions on days 1 and 2 of each 2 week cycle. (5FU + leucovorin may be eliminated from regimen per PI discretion)
Pembrolizumab
All participants will receive 400mg Pembrolizumab by IV infusion day 1 of every 3rd 2 week cycle.
RECRUITING
Moffitt Cancer Center, Tampa
Puma Biotechnology, Inc.
INDUSTRY
National Comprehensive Cancer Network
NETWORK
H. Lee Moffitt Cancer Center and Research Institute
OTHER