An observational study in Gastric Cancer, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Pfizer · Observational
To confirm the safety and efficacy of this drug under the actual use
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 8 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
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Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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100 patients
Exclusion Criteria:
- not specified in this study
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.
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.
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.
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.
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.
| Milestone | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: No informed consent for publication of study results | 1 |
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.
| Participants | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| ADR | 4 |
| Serious ADR | 0 |
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.
| Percentage of Participants | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 85.7 (42.1 to 99.6) |
Collected over 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 before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) | 2/7 (28.6%) | 3/7 (42.9%) | 6/7 (85.7%) |
| Event | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| Mechanical ileusGastrointestinal disorders | 1/7 |
| Sudden deathGeneral disorders | 1/7 |
| Neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/7 |
| Event | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 1/7 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/7 |
| ChillsGeneral disorders | 1/7 |
| PyrexiaGeneral disorders | 1/7 |
| Infusion related reactionInjury, poisoning and procedural complications | 1/7 |
| Renal impairmentRenal and urinary disorders | 1/7 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/7 |
| Pulmonary artery thrombosisRespiratory, thoracic and mediastinal disorders | 1/7 |
| HypertensionVascular disorders | 1/7 |
A total of 8 participants were enrolled in this study. Of the 8 participants from whom case report forms were collected. The 7 participants were included in the safety analysis set (SAS).
| Age, Customized(Participants) | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| <15 years | 0 |
| ≥15 and <65 years | 0 |
| ≥65 years | 7 |
| Sex: Female, Male(Participants) | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|---|
| Female | 1 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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