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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT00907868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ of the breast
* No invasive component
* No clinically palpable lymph node or presence of tumor cells in the sentinel lymph node (if done)
* No local recurrence of a primary breast cancer
* No multicentric or multifocal tumors not suitable for conservative surgery R0 with a margin ≥ 1 mm
* Has undergone bilateral mammography within 6 months before randomization
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 5 years
* Not pregnant
* Available for long-term follow up
* No history of in situ carcinoma in the contralateral breast
* No history of another cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
* No uncontrolled cardiac, renal, or pulmonary disease
* No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma)
* No HIV positivity
* Affiliated with the social health system
* No psychological, familial, sociological, or geographical situations that preclude compliance with study treatment and follow up
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent participation in another therapeutic trial (participation in epidemiologic studies is allowed)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00907868
Study Brief:
Protocol Section:
NCT00907868