Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer
Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10 minutes on days 1 and 8, and trastuzumab (Herceptin^®) IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive breast cancer
HER2/neu-positive by immunohistochemistry (3+ by HercepTest^â„¢ or equivalent) OR positive for amplification by fluorescent in situ hybridization
Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease
Measurable disease
At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan
The following are considered non-measurable disease:
No bone metastases as the only evidence of metastasis
Previously treated CNS metastases allowed provided disease has been stable for ≥ the past 3 months
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin ≤ 3.0 times the upper limit of normal (ULN)
One of the following must be true:
INR ≤ 1.5 times ULN
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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