Safety and Efficacy of Trastuzumab BS

CompletedOBSERVATIONAL
Enrollment

8

Participants

Timeline

Start Date

August 9, 2023

Primary Completion Date

March 27, 2025

Study Completion Date

March 27, 2025

Conditions
Gastric Cancer
Interventions
DRUG

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."

Trial Locations (1)

Unknown

Pfizer, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT04181333 - Safety and Efficacy of Trastuzumab BS | Biotech Hunter | Biotech Hunter