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:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00227656
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer that metastasized to the brain, meeting all of the following criteria:
* Must have ≥ 1 inoperable brain metastases, meeting 1 of the following criteria:
* Progressive or recurrent disease after prior whole-brain or stereotactic radiotherapy
* Ineligible for OR unwilling to be treated with radiotherapy
* At least 1 unidimensionally measurable brain metastasis by enhanced MRI within the past 21 days
* No progression or development of central nervous system (CNS) metastasis during prior treatment with capecitabine, fluorouracil, interferon alfa, or interferon beta
* Systemic (i.e., outside the CNS system) cancer must be stable
* No progressive disease (e.g., liver, lymphangitic, or lung metastases)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100%
Life expectancy
* More than 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 mg/dL
* No history of idiopathic thrombocytopenic purpura
* No known uncontrolled coagulopathy
* No increased risk for anemia (e.g., thalassemia or spherocytosis)
* No medically problematic anemia
Hepatic
* aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with concurrent liver metastases )
* Bilirubin ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN for patients with concurrent liver metastases; 10 times ULN for patients with concurrent bone metastases)
Renal
* Creatinine ≤ 1.5 times ULN OR
* Creatinine clearance ≥ 30 mL/min
Cardiovascular
* No congestive heart failure
* No symptomatic coronary artery disease
* No medically uncontrolled arrhythmia
* No other clinically significant cardiac disease
* No myocardial infarction within the past 12 months
Gastrointestinal
* No history of inflammatory bowel disease
* Must have intact upper gastrointestinal tract
* Able to swallow tablets
* No malabsorption syndrome
* No history of gastrointestinal bleeding
Immunologic
* No prior unanticipated severe reaction to fluoropyrimidine therapy, interferon, pegylated interferon, or a pegylated moiety
* No known sensitivity to fluorouracil
* No serious uncontrolled infection
* No history of immunologically mediated disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No known dihydropyrimidine dehydrogenase deficiency
* No history of depression characterized by a suicide attempt
* No history of hospitalization for psychiatric disease
* No history of other severe psychiatric disease
* No prior disability as a result of psychiatric disease
* No history of clinically significant psychiatric disability that would preclude study compliance
* No other malignancy within the past 5 years except cured nonmelanoma skin cancer or treated carcinoma in situ of the cervix
* No uncontrolled thyroid dysfunction (e.g., thyroid-stimulating hormone not in normal range)
* No evidence of severe retinopathy (e.g., Cytomegalovirus (CMV) retinitis or macular degeneration)
* No clinically relevant ophthalmologic disorders due to diabetes or hypertension
* No other serious uncontrolled medical conditions that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 3 months since prior interferon alfa or interferon beta
Chemotherapy
* See Disease Characteristics
* At least 3 months since prior capecitabine or fluorouracil
Endocrine therapy
* Concurrent hormonal agents (e.g., tamoxifen, raloxifene, or anastrazole) for breast cancer allowed
Radiotherapy
* See Disease Characteristics
Surgery
* More than 4 weeks since prior major surgery and recovered
Other
* More than 4 weeks since prior participation in another investigational drug study
* At least 4 weeks since prior and no concurrent brivudine or sorivudine
* No concurrent cimetidine
* No other concurrent investigational or commercial agents or therapies for this malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00227656
Study Brief:
Protocol Section:
NCT00227656