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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT00645866
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Stage IIIA or IIIB disease (T3 N1 M0, T4 N1 M0, any T N2/N3 M0)
* Bidimensionally measurable or evaluable disease
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-2
* Platelet count ≥ 100,000 cells/μL
* Total bilirubin normal
* Hemoglobin ≥ 8.0 g/dL
* ANC ≥ 1,000 cells/μL
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine clearance ≥ 50 mL/min and serum creatinine normal
* Life expectancy ≥ 3 months
* No uncontrolled infection
* No chronic debilitating disease
* No lack of physical integrity of the upper gastrointestinal tract
* Able to swallow tablets
* No malabsorption syndrome
* No clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias \[New York Heart Association class III-IV heart disease\] or myocardial infarction within the last 12 months)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or adequately treated other noninvasive carcinomas
* No peripheral neuropathy ≥ grade 1
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior major surgery and recovered
* No prior chemotherapy regimens including adjuvant therapy
* No organ allograft
* No concurrent sorivudine or bruvidine
* No other concurrent cytostatic, cytotoxic, immunomodulating agents, or radiotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00645866
Study Brief:
Protocol Section:
NCT00645866