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Doxorubicin in Treating Women With Advanced Breast Cancer

Phase 2
Conditions
Breast Cancer
Registration Number
NCT00003165
Lead Sponsor
University of Glasgow
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

Cancer Research Campaign Clinical Trials Unit-Birmingham (CRCTU)

🇬🇧

Birmingham, England, United Kingdom

Weston Park Hospital

🇬🇧

Sheffield, England, United Kingdom

Western General Hospital

🇬🇧

Edinburgh, Scotland, United Kingdom

Newcastle General Hospital

🇬🇧

Newcastle Upon Tyne, England, United Kingdom

Aberdeen Royal Infirmary

🇬🇧

Aberdeen, Scotland, United Kingdom

Beatson Oncology Centre

🇬🇧

Glasgow, Scotland, United Kingdom

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