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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT00397761
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
* Stage II-IIIB disease (T1-4, N1-2, M0)
* Previously untreated disease
* Previously unresected disease
* High-risk disease that is not resectable by lumpectomy alone
* Any HER2/neu status (positive, negative, or unknown) allowed
* Hormone receptor status:
* Any estrogen/progesterone status (positive, negative, or unknown) allowed
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9.0 g/dL
* Creatinine \< 1.5 mg/dL
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* ALT and AST \< 2.5 times ULN (5 times ULN if due to Gilbert's disease)
* Alkaline phosphatase \< 2.5 times ULN (5 times ULN if due to Gilbert's disease)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00397761
Study Brief:
Protocol Section:
NCT00397761