Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | April 5, 2005 | ||||
Last Updated Date | July 16, 2009 | ||||
Start Date ICMJE | June 2003 | ||||
Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE |
Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment | ||||
Change History | Complete list of historical versions of study NCT00107393 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer | ||||
Official Title ICMJE | Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression | ||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | Ishida T, Kiba T, Takeda M, Matsuyama K, Teramukai S, Ishiwata R, Masuda N, Takatsuka Y, Noguchi S, Ishioka C, Fukushima M, Ohuchi N. Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes. Cancer Chemother Pharmacol. 2009 Jul;64(2):361-9. Epub 2008 Dec 12. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 75 | ||||
Completion Date | |||||
Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Female | ||||
Ages | 20 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Japan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00107393 | ||||
Other Study ID Numbers ICMJE | CDR0000380787, TUGSM-UHA-BC03-01 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Tohoku University | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | October 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |