Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)
This study has been terminated.
Information provided by (Responsible Party):
First received: October 23, 2008
Last updated: November 6, 2013
Last verified: November 2013
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cardiac Safety Profile of Caelyx Therapy in Anthracyclin Pretreated Metastatic Breast Cancer Patients.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Cardiac Events [ Time Frame: Every 4 weeks during 6 cycles. ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||February 2006|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.
Other Name: SCH 200746
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