Status:
COMPLETED
Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
Lead Sponsor:
Tohoku University
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
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...
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 tra...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic disease
- Patients with only bone metastases are not eligible
- Refractory disease, defined as disease progression, drug-related adverse reaction, or disease relapse during or within 12 months after completion of paclitaxel or docetaxel AND doxorubicin or epirubicin administered in the neoadjuvant, adjuvant, or metastatic setting
- Total neoadjuvant or adjuvant taxane dose \> 700 mg/m\^2 for paclitaxel or \> 240 mg/m\^2 for docetaxel
- Total taxane dose \> 350 mg/m\^2 for paclitaxel or \> 120 mg/m\^2 for docetaxel in the metastatic setting
- Total neoadjuvant or adjuvant anthracycline dose \> 240 mg/m\^2 for doxorubicin or epirubicin
- Total anthracycline dose \> 120 mg/m\^2 for doxorubicin or epirubicin in the metastatic setting
- HER2/neu overexpression
- 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
- No symptomatic brain metastases
- No pleural or pericardial effusion or ascites
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 20 to 75
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-2
- Life expectancy
- At least 3 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Hepatic
- SGOT or SGPT ≤ 2.0 times upper limit of normal (ULN) (\< 3.0 times ULN for patients with liver metastases)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 mg/dL
- Renal
- Creatinine ≤ 1.2 mg/dL
- Cardiovascular
- LVEF \> 50%
- Pulmonary
- No interstitial pneumonia with pulmonary fibrosis
- Other
- No history of hypersensitivity reactions
- No serious, uncontrolled infection
- No other malignancy
- Not pregnant or nursing
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior trastuzumab (Herceptin®) for metastatic disease allowed
- Chemotherapy
- See Disease Characteristics
- No prior capecitabine
- At least 2 weeks since prior antimetabolites for metastatic disease
- At least 4 weeks since prior alkylating agents, carcinostatic antibiotics, or other carcinostatic agents
- Endocrine therapy
- At least 4 weeks since prior goserelin or leuprolide for metastatic disease
- At least 2 weeks since prior oral endocrine agents for metastatic disease
- No concurrent endocrine therapy
- Radiotherapy
- No prior radiotherapy to target lesions
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy, including radiotherapy for brain metastases
- Surgery
- Not specified
- Other
- Concurrent bisphosphonates for bone metastases allowed
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00107393
Start Date
June 1 2003
End Date
November 1 2008
Last Update
July 10 2013
Active Locations (10)
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1
Kitakyushu Municipal Medical Center
Fukuoka, Japan, 802-0077
2
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
3
Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
4
Saint Marianna University School of Medicine
Kanagawa, Japan, 216-8511