A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
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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).
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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