a study of capecitabine in combination with docetaxel vs capecitabine followed by docetaxel as first-line treatment for metastatic breast cancer

Conditions: Breast Cancer

Summary: 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).


Eligibility criteria:
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