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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00072293
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
* Largest tumor lesion ≤ 5 cm
* Palpable or nonpalpable breast lesion
* Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions
* Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
* At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension
* No clinical evidence of distant metastases
* No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:
* Skeletal pain of unknown cause
* Elevated alkaline phosphatase
* Bone scan showing hot spots
* No palpable axillary lymph node(s)
* No Paget's disease without invasive cancer
* Hormone receptor status:
* Estrogen receptor and progesterone receptor known
PATIENT CHARACTERISTICS:
Age
* Any age
Sex
* Female
Menopausal status
* Any status
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* See Disease Characteristics
Renal
* Not specified
Other
* Not pregnant or nursing
* No other prior or concurrent malignancy except the following:
* Adequately treated basal cell or squamous cell skin cancer
* Adequately treated carcinoma in situ of the cervix
* Adequately treated in situ melanoma
* Contralateral or ipsilateral carcinoma in situ of the breast
* No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
* Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No prior systemic therapy for breast cancer
* More than 1 year since prior chemopreventive agent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00072293
Study Brief:
Protocol Section:
NCT00072293