A Phase 1/2 interventional study of trastuzumab and pegylated liposomal doxorubicin hydrochloride in Breast Cancer, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-28.
Sponsored by NYU Langone Health · Phase 1/2, Interventional, and Treatment
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:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically proven breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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NYU Langone Health