drugset / Trial / NCT00431795
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
Phase 2
Terminated
100 enrolled
Hellenic Oncology Research Group
University Hospital of Crete · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy
Timeline
- Start
- 2003-06
- Primary completion
- 2012-06
- Completion
- 2012-06
Outcome
Outcome not reported
Stopped (Enrollment): “Due to poor accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |