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
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
Andrew D. Seidman, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|