Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with capecitabine works in treating women with metastatic breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression|
- Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment [ Designated as safety issue: No ]
- Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||November 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
- 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.
|Kitakyushu Municipal Medical Center|
|Fukuoka, Japan, 802-0077|
|Hiroshima University Hospital|
|Hiroshima, Japan, 734-8551|
|Hokkaido Cancer Center|
|Hokkaido, Japan, 003-0804|
|Saint Marianna University School of Medicine|
|Kanagawa, Japan, 216-8511|
|Osaka Kosei Nenkin Hospital|
|Osaka, Japan, 553-0003|
|National Hospital Organization - Osaka National Hospital|
|Osaka, Japan, 540-0006|
|Osaka University Graduate School of Medicine|
|Osaka, Japan, 565-0871|
|Tohoku University Graduate School of Medicine|
|Sendai, Japan, 980-8574|
|St. Luke's International Hospital|
|Tokyo, Japan, 104-8560|
|Sakata Municipal Hospital|
|Yamagata, Japan, 998-8585|
|Study Chair:||Noriaki Ohuchi, MD||Tohoku University|