Doxorubicin in Treating Women With Advanced Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|