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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00007904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage II or IIIA breast cancer
* At least 5 axillary lymph nodes
* No T4 or N3 disease
* No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation
* No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection
* Negative surgical margins
* Hormone receptor status:
* Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Male or female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,500/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No poorly controlled ischemic heart disease or congestive heart failure
Pulmonary:
* No severe chronic obstructive or restrictive pulmonary disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe diabetes mellitus
* No other severe concurrent medical or psychiatric illness that would preclude study participation
* No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00007904
Study Brief:
Protocol Section:
NCT00007904