A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
- Determine the response rate in women with metastatic breast cancer treated with two
different dose schedules of doxorubicin HCL liposome.
- Assess the side effects of these treatment regimens in this patient population.
- Determine the duration of response in these patients treated with these regimens.
- Assess the concentration of doxorubicin in tumor tissue in patients with easily
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available
lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior
chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two
- Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.
- Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks.
Treatment continues for at least 36 weeks in the absence of disease progression or
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for
Allocation: Randomized, Primary Purpose: Treatment
Robert E. Coleman, MD, FRCP
Cancer Research Centre at Weston Park Hospital
United States: Federal Government