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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00049660
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Metastatic disease
* Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting
* Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane
* Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane
* Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines
* At least one unidimensionally measurable lesion (phase II study)
* No CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal
* Creatinine clearance greater than 50 mL/min
Cardiovascular
* No symptomatic ventricular arrhythmias
* No clinically significant congestive heart failure
* No clinical or ECG evidence of myocardial infarction within the past 12 months
* No significant coronary artery disease
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix
* No known or prior sensitivity to fluoropyrimidines, including fluorouracil
* No pre-existing grade 2 or greater neurotoxicity
* No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic therapy
Chemotherapy
* See Disease Characteristics
* No more than 2 prior chemotherapy lines for metastatic disease
* No prior capecitabine, vinca alkaloids, or continuous fluorouracil
* No other concurrent chemotherapy
Endocrine therapy
* Prior hormonal therapy allowed
* No concurrent hormonal therapy
Radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study
* No other concurrent investigational treatment
* No concurrent brivudine with capecitabine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00049660
Study Brief:
Protocol Section:
NCT00049660