Breast Cancer Clinical Trial
Official title:
A Phase II Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of Herceptin Administered Subcutaneously in Combination With Paclitaxel in Women With HER2 Overexpressing Metastatic Breast Cancer
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. Drugs
used in chemotherapy use different ways to stop tumor cells from dividing so they stop
growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor
cells.
PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of
trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that
overexpresses HER2.
OBJECTIVES: I. Evaluate the safety and tolerability of subcutaneous trastuzumab (Herceptin)
plus paclitaxel in women with HER2 overexpressing metastatic breast cancer. II. Assess the
activity of this treatment regimen in these patients. III. Determine the pharmacokinetics of
trastuzumab and paclitaxel in this regimen.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one
of two treatment arms. Patients receive a loading dose of trastuzumab (Herceptin) IV over 90
minutes followed by paclitaxel IV over 3 hours on day 0. Paclitaxel is repeated every 3
weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I:
Patients receive trastuzumab subcutaneously (SC) weekly starting day 7. Arm II: Patients
receive trastuzumab SC twice weekly starting day 7. Treatment with trastuzumab SC continues
for 48 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study.
;
Allocation: Randomized, Primary Purpose: Treatment
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