Clinical trial NCT00078832 (phase 3, status: active, not recruiting)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: anastrozole, placebo
SMILES: CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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