Clinical trial

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)

NCT04181333

Name

B3271007

Description

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

Trial arms

Trial start

2023-08-09

Estimated PCD

2025-09-08

Trial end

2025-09-08

Status

Active (not recruiting)

Treatment

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.

Arms:

TRASTUZUMAB BS

Size

150

Primary endpoint

The incidence of adverse drug reactions in this surveillance

24 weeks

Eligibility criteria

Inclusion Criteria: * Patients with unresectable advanced/recurrent gastric cancer who are confirmed to have HER2 overexpression and started treatment with this drug\* * Patients who receive this drug\* for the first time after this drug\* is launched \* Not including the biological product, HERCEPTIN, and biosimilars of HERCEPTIN other than this drug Exclusion Criteria: - not specified in this study

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2024-03-04

1 organization

1 drug

1 indication

Organization

Pfizer

Indication

Stomach Cancer

Drug

Trastuzumab