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RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill breast cancer cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy.
- Determine the response rate of patients with HER2-positive metastatic breast cancer treated with trastuzumab (Herceptin) and interleukin-2 after failure on a prior trastuzumab regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of trastuzumab in these patients.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1 and 8 and interleukin-2 subcutaneously (SC) on days 2-7 and 9-21. Beginning on day 22, patients receive trastuzumab IV over 30 minutes every 14 days. Patients also receive interleukin-2 SC daily on days 1-14. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
Primary Purpose: Treatment
Louis A. Weiss Memorial Hospital
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:25-0400
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A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
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