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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00424203
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive adenocarcinoma of the breast
* Stage I, II or III disease
* pN+ or pN0 with grade III disease (tumor size ≥ 2 cm)
* No metastatic disease
* Must have undergone prior conservative or radical surgery that included axillary lymph node or sentinel node dissection
* No residual tumor
* Negative margins
* Hormone receptor status:
* Estrogen receptor and progesterone receptor negative
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 10 g/dL
* Alkaline phosphatase \< 2.5 times upper limit of normal (ULN)
* Bilirubin \< 1.25 times ULN
* AST and ALT \< 2.5 times ULN
* Creatinine clearance ≥ 40 mL/min
* No contraindication to receiving anthracyclines or alkalizing agents
* FEV normal
* Activities of Daily Living (ADL) score ≥ 5
* No decrease of ≥ 1 point within the past 3 months
* None of the following at baseline:
* Cognitive deficiency (Folstein Mini-Mental State \< 25)
* Severe depression (Geriatric Depression Scale ≥ 20)
* Severe malnutrition (Mini-Nutritional Assessment ≤ 17)
* No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics grade 3-4), including any of the following:
* Cardiac insufficiency
* Unstable angina
* Myocardiopathy
* Myocardial infarction within the past year
* Uncontrolled hypertension
* Uncontrolled high-risk arrhythmia
* Severe medullary insufficiency
* Neurological or psychological condition that would preclude study consent
* Uncontrolled or active infection
* Severe urinary tract infection
* Preexisting hematuria
* Active ulcer
* Uncontrolled diabetes
* No other cancer within the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
* No familial, geographical, social, or psychological condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 60 days since prior therapeutic surgery
* At least 4 weeks since prior investigational drugs
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT00424203
Study Brief:
Protocol Section:
NCT00424203