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:
NCT00309920
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage III disease (pT1, N2-3, M0)
* No metastatic disease by thoracic x-ray, full-body bone scan, and liver sonography
* No inflammatory disease or Paget's disease
* Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed
* Underwent surgery approximately 42 days ago
* At least 9 positive lymph nodes
* No prior sequential mastectomy
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* ECOG performance status 0-1
* WBC ≥ 3,500/mm\^3
* Creatinine ≤ 1.4 mg/dL
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 2.0 mg/dL
* No pre-existing symptomatic peripheral neuropathy
* Not pregnant or nursing
* No hypersensitivity to darbepoetin alfa, epoetin alfa, or any of their components
* No other malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No participation in another clinical study
* No prior therapies that would preclude study participation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00309920
Study Brief:
Protocol Section:
NCT00309920