A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer

Study Overview
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Brief Summary
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To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: XELODA [capecitabine]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70% Have confirmed breast cancer with locally advanced and/or metastases Have at least one site with defined tumor Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy Exclusion Criteria: Pregnant/lactating women Women of childbearing potential with either a positive or no pregnancy test Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential) Prior treatment with chemotherapy in the advanced/metastatic setting HER 2/neu positive status without prior treatment with trastuzumab Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse Mitomycin C or nitrosoureas within 6 weeks preceding treatment start Organ allografts requiring immunosuppressive therapy Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy Hormonal therapy within 10 days preceding study treatment start Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start Participation in any investigational drug study within 4 weeks preceding treatment start Prior unanticipated severe reaction to fluoropyrimidine therapy Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues Evidence of CNS metastases History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma Clinically significant (i.e. active) cardiac disease Abnormal laboratory values Severe renal impairment Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease Lack of physical integrity of the upper GI tract Life expectancy of less than 3 months Unwilling/unable to comply with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: XELODA [capecitabine]|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |