N/A
N=8
Safety and Efficacy of Trastuzumab BS
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04181333 ↗Enrolled (actual)
8
Serious AEs
42.9%
Results posted
Apr 2026
Primary outcome: Primary: The Incidence of Adverse Drug Reactions (ADRs) — 4; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TRASTUZUMAB BS (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Adverse Drug Reactions (ADRs) |
4; 0 | — |
| SECONDARY Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
85.7 | — |
Summary
To confirm the safety and efficacy of this drug under the actual use
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04181333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.