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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00078832
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Meets at least 1 of the relative risk factors based on age as follows:
* 45 to 70 years of age:
* First-degree relative who developed breast cancer at ≤ 50 years of age
* First-degree relative who developed bilateral breast cancer
* Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer
* Participants having both relatives who are second degree and on the opposite sides of the family must have at least one that was diagnosed at ≤ 50 years of age
* Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer
* Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer
* Mammographic opacity covering at least 50% of the breast in the absence of hormone replacement therapy within the past 3 months
* 60 to 70 years of age:
* First-degree relative with breast cancer at any age
* Age at menopause ≥ 55 years
* Nulliparous or age at first birth ≥ 30 years
* 40 to 44 years of age:
* Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer at ≤ 50 years of age
* First-degree relative with bilateral breast cancer who developed the first breast cancer at ≤ 50 years of age
* Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer at ≤ 40 years of age
* Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer at ≤ 40 years of age
* All age groups (40 to 70 ears of age) with a 10-year risk \> 5% who do not fit into the above categories are allowed
* Clearly apparent family history AND/OR other risk factors indicating appropriate increased risk of breast cancer for age
* The following prior breast conditions are allowed (for all age groups):
* Lobular carcinoma in situ
* Atypical ductal or lobular hyperplasia in a benign lesion
* Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated by mastectomy
* No evidence of breast cancer on mammogram within the past year
* Hormone receptor status:
* For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive
* Must have had greater than or equal to 5% positive cells
PATIENT CHARACTERISTICS:
Age
* 40 to 70
Sex
* Female
Menopausal status
* Postmenopausal, defined as at least 1 of the following:
* Over 60 years of age
* Bilateral oophorectomy
* ≤ 60 years of age with a uterus and amenorrhea for at least 12 months
* ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels \> 30 IU/L
Performance status
* Not specified
Life expectancy
* At least 10 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Psychologically and physically suitable to receive 5 years of anti-estrogen therapy
* No cancer within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix
* No evidence of osteoporosis or fragility fractures within the spine
* Participants with a T-score \> minus 4 and no more than 2 fragility fractures are allowed
* No concurrent severe disease that would place the participant at unusual risk or confound the results of the study
* No other medical condition that would preclude the ability to receive the study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* No prior tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM) use for more than 6 months in duration unless an IBIS-I participant (must have been off trial therapy for at least 5 years.
* No concurrent tamoxifen, raloxifene, or other SERM
* No concurrent estrogen-based hormone replacement therapy
* No concurrent systemic estrogen replacement therapy, including vaginal estrogen preparations
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No prior prophylactic mastectomy
* No concurrent prophylactic mastectomy
Other
* More than 6 months since prior investigational drugs
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00078832
Study Brief:
Protocol Section:
NCT00078832