Doxorubicin in Treating Women With Advanced Breast Cancer
|ClinicalTrials.gov Identifier: NCT00003165|
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 30, 2004
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: doxorubicin-HPMA conjugate||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||A Phase II Trial of PK1 in Women With Advanced Breast Cancer|
|Study Start Date :||December 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003165
|Cancer Research Campaign Clinical Trials Unit-Birmingham (CRCTU)|
|Birmingham, England, United Kingdom, B15 2TT|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 9NQ|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Chris Twelves, MD, BMedSci, FRCP||University of Glasgow|