CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
TRASTUZUMAB BSdrug
Likely dose
TRASTUZUMAB BS 4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04181333
NCT04181333N/ACompleted

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)

Pfizer·observational·Posted Nov 29, 2019·Updated Apr 14, 2026

In Brief

An observational study evaluating TRASTUZUMAB BS for Gastric Cancer. Completed, enrolled 8 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 29, 2019
Enrollment StartAug 9, 2023
Primary CompletionMar 27, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.6 years ago

Interventions

TRASTUZUMAB BSdrug

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.