8
Participants
Start Date
August 9, 2023
Primary Completion Date
March 27, 2025
Study Completion Date
March 27, 2025
TRASTUZUMAB BS
"Regimen A or regimen B is used for HER2-overexpressing breast cancer.~RegimenB is used for HER2-overexpressing unresectable advanced or recurrent gastric cancer in combination with other anti tumor agent(s).~Regimen A: The recommended dose for trastuzumab (genetical recombination) \[Trastuzumab Biosimilar 3\] in adult patients is 4 mg/kg (weight) at initial dose and 2 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every week.~Regimen B: The recommended dose for trastuzumab (genetical recombination) \[Trastuzumab Biosimilar 3\] in adult patients is 8 mg/kg (weight) at initial dose and 6 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every 3 weeks.~If the initial dose is well tolerated, the dosing time after the second dose can be shortened up to 30 minutes."
Pfizer, Tokyo
Lead Sponsor
Pfizer
INDUSTRY