Breast Cancer Clinical Trial
Official title:
Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver
tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to make tumor cells stop dividing so they stop growing or die. Combining
monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in
treating patients who have metastatic breast cancer that overexpresses HER2.
OBJECTIVES:
- Determine the pharmacokinetics and pharmacodynamics of trastuzumab (Herceptin) and
paclitaxel in patients with HER2-overexpressing metastatic breast cancer.
- Provide access to trastuzumab and paclitaxel for these patients.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV
over 1 hour weekly. Patients receive trastuzumab alone during course 1 and then in
combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until
patients achieve a sustained complete response of 8 weeks or disease progression occurs.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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