RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different forms may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer.
OBJECTIVES: I. Determine the antitumor activity of doxorubicin-HPMA conjugate (PK1) in women with advanced breast cancer. OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin-HPMA conjugate (PK1) by intravenous infusion once every 3 weeks. Patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease. PROJECTED ACCRUAL: 14-25 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
25
Cancer Research Campaign Clinical Trials Unit-Birmingham (CRCTU)
Birmingham, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
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Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom