Gastric CancerNCT04181333
Safety and Efficacy of Trastuzumab BS
An observational study of Gastric Cancer, run by Pfizer at 1 site in Japan.
Trial summary
To confirm the safety and efficacy of this drug under the actual use Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- TRASTUZUMAB BS
- Type of treatment
- Injection or infusion
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 9 Aug 2023to 27 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100 patients
Who may be able to join
- 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
Who cannot join
- not specified in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gastric Cancer
- Being tested
- TRASTUZUMAB BS
- Keywords
- Recurrent HER2-Overexpressing Gastric Cancer, TRASTUZUMAB BS
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| TRASTUZUMAB BS | Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS Receives: Drug: TRASTUZUMAB BS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Drug Reactions (ADRs)
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.
Measured: 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 outcomes (1)
Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start9 Aug 2023
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181333
- Sponsor's protocol ID
- B3271007
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2019
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04181333
- Acronym / sponsor ID
- B3271007
- Conditions
- Gastric Cancer
- Keywords
- Recurrent HER2-Overexpressing Gastric Cancer, TRASTUZUMAB BS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the safety and efficacy of this drug under the actual use
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRASTUZUMAB BS | – | Drug: TRASTUZUMAB BSUnresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- not specified in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRASTUZUMAB BSRegimen 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. | Drug | TRASTUZUMAB BS |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.