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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT00274768
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
* Evidence of metastatic involvement (stage IV disease)
* Patients must have measurable disease
* At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
* Treated brain metastases (surgery or radiation therapy) allowed if clinically stable
* Patients with leptomeningeal disease are ineligible
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Male or female
* Menopausal status not specified
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine clearance \> 50 mL/min
* Fertile patients must use effective contraception
* No history of another severe and/or life-threatening medical disease
* No other active primary malignancy
* Not pregnant or nursing
* Negative pregnancy test
* Patients with asymptomatic HIV infection are eligible
* Liver dysfunction score ≤ 9
* No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)
* No active gastrointestinal malabsorption illness
* No clinically significant cardiac disease, including the following:
* Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months
* No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
* No history of uncontrolled seizures or central nervous system disorders
* No significant history of noncompliance to medical regimens
* No clinically significant psychiatric disability that would preclude study compliance
PRIOR CONCURRENT THERAPY:
* No previous capecitabine
* Up to 3 prior cytotoxic regimens allowed for metastatic disease
* Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)
* No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy
* No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy
* No other concurrent investigational drugs
* No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)
* Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
* At least 4 weeks since prior sorivudine or brivudine
* Concurrent use of bisphosphonates allowed if initiated before beginning study therapy
* Concurrent use of megestrol acetate suspension as an appetite stimulant allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00274768
Study Brief:
Protocol Section:
NCT00274768