Safety and Efficacy of Trastuzumab BS

Active, not recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: TRASTUZUMAB BS

• Registration Number: NCT04181333
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Study Start: 2023-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• not specified in this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TRASTUZUMAB BS	TRASTUZUMAB BS	Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reactions in this surveillance	24 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1.	24 Weeks

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan