Breast Cancer Clinical Trial
Official title:
Phase II Study of Weekly 1-Hour Paclitaxel (Taxol) Plus Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in the Treatment of Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Monoclonal antibodies 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 cancer cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody
therapy in treating women with recurrent or metastatic breast cancer.
OBJECTIVES: I. Determine the therapeutic efficacy of paclitaxel in combination with
monoclonal antibody HER2 (Herceptin) in women with recurrent or metastatic breast cancer.
II. Evaluate the safety of this combination regimen in these patients.
OUTLINE: Patients are stratified by tumor expression of HER2 (overexpression vs normal).
Patients receive a loading dose of monoclonal antibody HER2 (Herceptin) intravenously over
90 minutes on day 0. Paclitaxel is administered intravenously over 1 hour on day 1. Starting
on day 7, patients receive paclitaxel by infusion over 1 hour every 7 days. Monoclonal
antibody HER2 is administered intravenously over 30 minutes immediately following paclitaxel
every 7 days. Treatment continues in the absence of disease progression and unacceptable
toxicity. Patients are followed until death.
PROJECTED ACCRUAL: This study will accrue 50 patients in approximately 6 months.
;
Primary Purpose: Treatment
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