Safety and Efficacy of Trastuzumab BS

March 25, 2026 updated by: Pfizer

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Pfizer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

100 patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TRASTUZUMAB BS
Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of Adverse Drug Reactions (ADRs)
Time Frame: From Day 1 to 28 days after the last dose within 24 weeks; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks.
An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and/or 150mg [Pfizer] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to this drug was assessed.
From Day 1 to 28 days after the last dose within 24 weeks; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame: From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued, it ends at the time of discontinuation. Maximum duration was 28 weeks.

The physician in charge evaluated the effectiveness of this drug based on the best overall response [complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), inevaluable (NE) or Non-CR/Non-PD] using the effectiveness assessment items in the RECIST Version 1.1 at the end of the observation period or at discontinuation.

The physician identified target lesions and non-target lesions in the classification of tumor lesions at the start of administration of this drug, and confirmed the presence or absence of new lesions in addition to the results of assessment of tumor response in each tumor lesion during the observation period, and then evaluated overall response.

The total proportion of participants with CR + PR was evaluated as an overall response (OR) rate along with a 95% confidence interval.
From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued, it ends at the time of discontinuation. Maximum duration was 28 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Actual)

March 27, 2025

Study Completion (Actual)

March 27, 2025

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3271007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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