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

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