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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT00001250
Eligibility Criteria:
INCLUSION CRITERIA
Women of any age with clinical stage II breast cancer who met the following criteria:
Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm in size with axillary lymph nodes which are clinically (\[N0 or N1\] \[T1N1, T2N0, T2N1\]).
Patients will be staged according to the 1986 AJCC TMM classification.
Patients with bilateral breast cancer will be eligible provided at least one tumor is invasive and classified as stage I or II, and neither breast is stage III.
Histologic sections of the breast tumor must be classified as an invasive primary breast neoplasm of epithelial origin.
Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
Patients must be mentally competent to understand and give informed consent for the protocol.
Estrogen receptor (ER) status can include ER positive, negative, or unknown.
Patients with prior cancers may be eligible as long as they have received curative therapy and have had no evidence of recurrence for greater than or equal to 10 years.
EXCLUSION CRITERIA
Patients will be excluded from this protocol for the following reasons:
Advanced local disease or distant metastases (stage III or IV).
Previous therapy to the breast other than excisional biopsy.
Pregnancy.
Unwillingness to use birth control during chemotherapy.
Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may render the patient a poor risk for surgery or chemotherapy. Specifically, liver function - SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine clearance should be greater than 45 ml/min. If there is any history of cardiac disease, patients must have a normal ejection fraction on MUGA scan and no angina.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00001250
Study Brief:
Protocol Section:
NCT00001250