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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
116
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, Austria
Institut Bergonie
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institut Curie - Section Medicale
Paris, France
Centre Henri Becquerel
Rouen, France
University of Ioannina
Ioannina, Greece
Rabin Medical Center - Beilinson Campus
Petah Tikva, Israel
Mario Negri Institute for Pharmacological Research
Milano (Milan), Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy
Academisch Ziekenhuis Groningen
Groningen, Netherlands
...and 4 more locations