- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00107393
Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Fukuoka, Japan, 802-0077
- Kitakyushu Municipal Medical Center
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hokkaido, Japan, 003-0804
- Hokkaido Cancer Center
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Kanagawa, Japan, 216-8511
- Saint Marianna University School of Medicine
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Osaka, Japan, 540-0006
- National Hospital Organization - Osaka National Hospital
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Osaka, Japan, 553-0003
- Osaka Kosei Nenkin Hospital
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Osaka, Japan, 565-0871
- Osaka University Graduate School of Medicine
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Sendai, Japan, 980-8574
- Tohoku University Graduate School of Medicine
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Tokyo, Japan, 104-8560
- St. Luke's International Hospital
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Yamagata, Japan, 998-8585
- Sakata Municipal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment
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Secondary Outcome Measures
Outcome Measure |
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Response rate
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Progression-free survival
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Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment
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Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Noriaki Ohuchi, MD, Tohoku University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUGSM-UHA-BC03-01
- CDR0000380787 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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