Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00107393
- Lead Sponsor
- Tohoku University
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival Response rate Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment
Trial Locations
- Locations (10)
Hokkaido Cancer Center
🇯🇵Hokkaido, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Saint Marianna University School of Medicine
🇯🇵Kanagawa, Japan
Kitakyushu Municipal Medical Center
🇯🇵Fukuoka, Japan
Osaka Kosei Nenkin Hospital
🇯🇵Osaka, Japan
National Hospital Organization - Osaka National Hospital
🇯🇵Osaka, Japan
Osaka University Graduate School of Medicine
🇯🇵Osaka, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
Sakata Municipal Hospital
🇯🇵Yamagata, Japan
Tohoku University Graduate School of Medicine
🇯🇵Sendai, Japan