NCT04181333

Safety and Efficacy of Trastuzumab BS

TRASTUZUMAB BS for Intravenous Infusion 60 mg [Pfizer], TRASTUZUMAB BS for Intravenous Infusion 150 mg [Pfizer] General Investigation (Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

To confirm the safety and efficacy of this drug under the actual use

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-09
• Primary completion: 2025-03-27
• Completion: 2025-03-27
• First posted: 2019-11-29
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study