Breast Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is
more effective for metastatic breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal
doxorubicin in treating women who have metastatic breast cancer.
OBJECTIVES:
- 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
accessible metastases.
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
treatment arms.
- 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
unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for
this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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