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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00014612
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer
* T0-2, N0
* Diagnosis by excisional tumorectomy allowed
* Clinically occult invasive disease must be histologically confirmed
* Only 1 tumor in 1 breast
* Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI
* Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
* Multicentric (i.e., in different quadrants) breast cancer is not allowed
* Clinically negative axillary lymph nodes
* No metastatic disease
* No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Any age
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to axilla
Surgery:
* No prior surgery to axilla
Other:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00014612
Study Brief:
Protocol Section:
NCT00014612