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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00433420
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary breast cancer
* No histology other than carcinoma
* Node-positive disease
* Must have at least 1 involved axillary node or internal mammary node
* Previously resected disease
* Has undergone radical surgery (i.e., mastectomy or conservative surgery) with axillary node dissection within the past 7 weeks
* No inflammatory carcinoma
* No prior or concurrent ipsilateral or contralateral invasive breast carcinoma
* No metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* ECOG performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* WBC ≥ 4,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No chronic liver or renal disease
* No other serious medical illness requiring medication
* No other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
* No symptomatic peripheral neuropathy \> grade 2
* No hypersensitivity to study drugs or their components
* No recent myocardial infarction, congestive heart failure, or serious arrhythmia
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy
* No prior cytotoxic regimens
* No prior radiation therapy, except for intraoperative radiation therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00433420
Study Brief:
Protocol Section:
NCT00433420