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

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).

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