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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT00004092
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis
* Stage II with at least 10 positive axillary nodes OR
* Stage IIIA or IIIB
* No histologically proven bone marrow metastasis
* No CNS metastasis
* Hormone receptor status:
* Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
* Physiological age 60 or under
Menopausal status:
* Not specified
Performance status:
* Karnofsky 80-100%
Life expectancy:
* See Disease Characteristics
Hematopoietic:
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT or SGPT no greater than 2 times upper limit of normal
* Hepatitis B antigen negative
Renal:
* Creatinine no greater than 1.2 mg/dL
* Creatinine clearance at least 70 mL/min
* No prior hemorrhagic cystitis
Cardiovascular:
* Ejection fraction at least 55% by MUGA
* No prior significant valvular heart disease or arrhythmia
Pulmonary:
* FEV\_1 at least 60% of predicted
* pO\_2 at least 85 mm Hg on room air
* pCO\_2 at least 43 mm Hg on room air
* DLCO at least 60% lower limit of predicted
Other:
* No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix
* No CNS dysfunction that would preclude compliance
* HIV negative
* No sensitivity to E. coli-derived products
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 4 weeks since prior chemotherapy
* No prior doxorubicin of total dose exceeding 240 mg/m\^2
* No prior paclitaxel of total dose of at least 750 mg/m\^2
* No more than 12 months since prior conventional-dose adjuvant chemotherapy
Endocrine therapy:
* At least 4 weeks since prior hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No prior radiation to the left chest wall
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT00004092
Study Brief:
Protocol Section:
NCT00004092