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Phase II Study of Capecitabine, Vinorelbine, and Trastuzumab (Herceptin®) as First-Line Treatment in Patients With HER2/neu-Overexpressing Metastatic Breast Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Projected Accrual Outline Trial Contact Information
Alternate Title
Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Approved-not yet active
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18 and over
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NCI
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NCCTG-N0337
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Objectives Primary - Determine the overall response rate in patients with HER2/neu-overexpressing metastatic breast cancer treated with first-line therapy comprising capecitabine, vinorelbine, and trastuzumab (Herceptin®).
Secondary - Determine the time to disease progression, duration of response, and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen in these patients.
Entry Criteria Disease Characteristics:
- Histologically or cytologically confirmed invasive breast cancer
- HER2/neu-positive by immunohistochemistry (3+ by HercepTest™ or equivalent) OR positive for amplification by fluorescent in situ hybridization
- Testing may be performed in the primary tumor or the metastatic site
- Disease progression after prior adjuvant or neoadjuvant taxane-based therapy
- 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:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No bone metastases as the only evidence of metastasis
- No known CNS metastases
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy - Prior adjuvant trastuzumab (Herceptin®) allowed
- No concurrent immunotherapy
Chemotherapy - See Disease Characteristics
- No prior chemotherapy in the metastatic (non-adjuvant) setting
- No prior continuous (≥ 24 hours) fluorouracil infusion
- No prior capecitabine
- No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)
Endocrine therapy - At least 1 day since prior hormonal therapy
- No concurrent hormonal therapy
Radiotherapy - More than 4 weeks since prior radiotherapy to the axial skeleton
- No concurrent radiotherapy
Surgery - More than 4 weeks since prior major surgery
- No prior organ allografts requiring immunosuppressive therapy
Other - More than 4 weeks since prior participation in an investigational drug study
- No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
- No other concurrent cytotoxic agents
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,500/mm3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm3
- No known uncontrolled coagulopathy
Hepatic - Bilirubin ≤ 3.0 times the upper limit of normal (ULN)
- One of the following must be true:
- AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- INR ≤ 1.5 times ULN
- PT normal
Renal - Calcium ≤ 11.5 mg/dL
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 30 mL/min
Cardiovascular - LVEF ≥ 50% by MUGA or echocardiogram
- No clinically significant (i.e., active) cardiac disease
- No congestive heart failure
- No symptomatic coronary artery disease
- No myocardial infarction within the past 12 months
- No cardiac arrhythmia not controlled with medication
Gastrointestinal - Able to take oral medication
- No lack of physical integrity of the upper gastrointestinal tract
- No clinically significant malabsorption syndrome
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study participation
- No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically similar agents
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No know hypersensitivity to fluorouracil
- No known dihydropyrimidine dehydrogenase deficiency
- No history of uncontrolled seizures or CNS disorders
- No clinically significant psychiatric disability that would preclude giving informed consent or study compliance
- No other serious uncontrolled infection or disease
- No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer
Projected Accrual A total of 5-47 patients will be accrued for this study within 23 months. 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. Disclaimer The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group | | | Winston Tan, MD, Protocol chair | | | | Muhammad Salim, MD, Protocol co-chair | | | | Edith Perez, MD, Protocol co-chair | | | | Back to Top |
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