Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00087620
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00087620
Study Brief:
Protocol Section:
NCT00087620