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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00003857
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
* Unicentric
* Lesions ≤ 2.5 cm
* Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in \< one third of the involved ducts
* Inked margins ≥ 3 mm
* Clinically node negative
* Non-palpable
* No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery
* No bloody nipple discharge
* No more than 12 weeks since prior final surgery (arm II only)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 26 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* No active connective tissue disorders (e.g., lupus or scleroderma)
* No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
26 Years
Maximum Age:
120 Years
Study:
NCT00003857
Study Brief:
Protocol Section:
NCT00003857