Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer
An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial was terminated prematurely because of recruitment difficulties.
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.
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 |
|---|---|---|---|
| Urinary Tract Cancer | Malignant Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab Monotherapy
- description
- Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks.
- interventionNames
- Drug: trastuzumab
Primary outcomes (3)
- measure
- Progression-Free Survival (PFS) - Percentage of Participants With an Event
- timeFrame
- Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
- description
- PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.
- measure
- Progression-Free Survival - Time to Event
- timeFrame
- Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients \>=18 years of age; * metastatic urothelial cancer; * disease progression during or after 1 prior platinum-based chemotherapy; * measurable disease; * HER2 overexpression (IHC \[2+\] or \[3+\]). Exclusion Criteria: * concomitant chemotherapy or immunotherapy; * active or uncontrolled infection; * solely CNS metastases; * clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea; * co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
References
Publications (0)
Data not yet available