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A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.
OBJECTIVES: * Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer. * Determine the efficacy of this regimen in these patients. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Start Date
July 1, 2000
Primary Completion Date
July 1, 2004
Last Updated
March 28, 2011
trastuzumab
BIOLOGICAL
pegylated liposomal doxorubicin hydrochloride
DRUG
Lead Sponsor
NYU Langone Health
Collaborators
NCT04550494
NCT05673200
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