Clinical trial · Observational
Safety and Efficacy of Trastuzumab BS
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)
NCT04181333CI-TRIAL-00108210completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To confirm the safety and efficacy of this drug under the actual use
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRASTUZUMAB BS | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TRASTUZUMAB BS
- description
- Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS
- interventionNames
- Drug: TRASTUZUMAB BS
Primary outcomes (1)
- measure
- The Incidence of Adverse Drug Reactions (ADRs)
- timeFrame
- 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.
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.