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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00002920
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following histologically proven diagnoses:
* Primary invasive adenocarcinoma of the unilateral or bilateral breast
* Stage I, IIA, or IIB (T1-3, N0-1, M0)
* No recurrent invasive breast cancer
* Ductal carcinoma in situ (DCIS)
* Lobular carcinoma in situ (LCIS) with microinvasion
* Paget's disease of the nipple
* No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast
* Currently free of breast cancer (no evidence of disease)
* No evidence of distant disease on chest x-ray or chest CT scan and mammogram of the opposite breast within the past year
* Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy) and either axillary node or sentinel node biopsy
* Surgical margins clear of both infiltrating carcinoma (any type) and DCIS
* No gross or microscopically positive margins except:
* Invasive cancer or DCIS at the focal margin treated with definitive radiotherapy
* Gross or LCIS at the final margin
* Biopsy requirement waived for DCIS or LCIS with minimal microinvasion
* Patients with breast-sparing procedure must have received or be planning to receive radiotherapy at start of tamoxifen treatment
* No endometrial simple or cystic hyperplasia, proliferative changes, complex (adenomatous) or atypical hyperplasia, or carcinoma
* Patients must be planning one of the following:
* Starting adjuvant tamoxifen for five years OR
* Started tamoxifen within 28 days prior to study and planning to receive adjuvant tamoxifen for five years
* Hormone receptor status:
* Candidate for adjuvant tamoxifen therapy
PATIENT CHARACTERISTICS:
Age:
* Adult
Sex:
* Female
Menopausal status:
* Postmenopausal defined as:
* At least 1 year since last menstrual period
* At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis
* 4-12 months since last menstrual period and FSH elevated to postmenopausal range
* Postmenopausal estrogen therapy and 55 years of age or older
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Fertile patients must use effective contraception during and for at least 2 months after study
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
* No concurrent nonmalignant-related illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Adjuvant chemotherapy allowed
* No concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* No prior hormonal treatment for breast cancer (except tamoxifen)
* No concurrent postmenopausal estrogen therapy
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
* No prior or concurrent hysterectomy
Other:
* No prior or current participation in an adjuvant intergroup trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00002920
Study Brief:
Protocol Section:
NCT00002920