Last reviewed · How we verify
Cardiac Safety Profile of Caelyx Therapy in Anthracyclin Pretreated Metastatic Breast Cancer Patients.
The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | 2006-02 |
| Completion | 2006-08 |
Conditions
- Breast Neoplasm
Interventions
- Pegylated Liposomal Doxorubicin
Primary outcomes
- Cardiac Events — Every 4 weeks during 6 cycles.
A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of \>=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of \>=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).