|Breast Neoplasm||Drug: Pegylated Lyposomal Doxorubicin Drug: Cyclophosphamide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer|
|Study Start Date:||March 2003|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2
Drug: Pegylated Lyposomal Doxorubicin
Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
Other Name: SCH 200746Drug: Cyclophosphamide
Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.