Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression
- Determine the median survival time and 2-year survival rate in women with taxane- and
anthracycline-refractory HER2/neu-overexpressing metastatic breast cancer treated with
trastuzumab (Herceptin®) and capecitabine.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the clinical benefit rate of this regimen in these patients.
- Determine the safety profile of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
with trastuzumab (Herceptin®) (yes vs no), HER2/neu status (3+ by immunohistochemistry vs
positive by fluorescence in situ hybridization), and class of refractory disease (primary vs
secondary vs treatment discontinuation due to adverse events).
Patients receive oral capecitabine once daily on days 1-21 and trastuzumab IV on days 1, 8,
15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment
Noriaki Ohuchi, MD
United States: Federal Government