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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00077168
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component
* Microinvasion (defined as 1 or more foci of invasion each \< 1 mm) allowed
* Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required
* Maximum microscopic tumor diameter \< 30 mm (\< 15 mm if grade 3 tumor)
* Planning to receive adjuvant tamoxifen or anastrozole for 5 years
* Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II
* Hormone receptor status:
* Estrogen receptor positive OR
* Progesterone receptor positive
* More than 10% tumor staining for receptor OR a cutpoint of ≥ 2
PATIENT CHARACTERISTICS:
Sex
* Female
Menopausal status
* Premenopausal, perimenopausal, or postmenopausal
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No prior deep vein thrombosis
Pulmonary
* No prior pulmonary embolus
Other
* No unexplained postmenopausal bleeding
* No contraindication to full-dose radiotherapy to the breast
* No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* See Disease Characteristics
* No prior tamoxifen or raloxifene use for more than 3 months in duration
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No prior mastectomy
Other
* No concurrent anticoagulants
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00077168
Study Brief:
Protocol Section:
NCT00077168