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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT00244959
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer meeting 1 of the following criteria:
* Ductal carcinoma in situ (DCIS)
* Invasive carcinoma
* Stage I-III disease
* Must have undergone breast cancer surgery within the past 6 months, including any of the following:
* Mastectomy or lumpectomy with or without radiation
* Sentinel node and/or axillary node dissection
* Re-excision of lumpectomy margins
* Intact contralateral breast
* No prior radiation therapy or mastectomy
* Prior biopsies allowed
* Hormone receptor status:
* Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining
PATIENT CHARACTERISTICS:
Sex
* Female
Menopausal status
* Postmenopausal, defined as 1 of the following:
* At least 60 years of age
* Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry
* Less than 60 years of age, amenorrheic for \< 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
* Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range
* Underwent prior bilateral oophorectomy
* Underwent prior radiation castration AND amenorrheic for ≥ 6 months
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior or concurrent adjuvant chemotherapy for breast cancer
Endocrine therapy
* No prior aromatase inhibitor
* At least 6 weeks since prior and no concurrent tamoxifen
* At least 6 weeks since prior and no concurrent hormone replacement therapy
* Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed
* At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene)
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease Characteristics
* No contralateral breast implant
Other
* Concurrent bisphosphonates allowed at the discretion of the treating oncologist
* No concurrent consumption of soy supplements
* Concurrent routine dietary consumption of soy-containing foods allowed
* No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00244959
Study Brief:
Protocol Section:
NCT00244959