Clinical trial NCT00238316 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: letrozole
SMILES: N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  At increased risk for the development or recurrence of breast cancer, as defined by 1
             of the following:

               -  Baseline mammogram indicating mammographic density occupying ≥ 25% (grade 4/6,
                  5/6, or 6/6) of the breast tissue

                    -  No suspicion of breast cancer, unless subsequently ruled out

               -  Prior ductal carcinoma in situ (DCIS)

                    -  Untreated disease OR > 6 months since completion of adjuvant endocrine
                       therapy

                    -  Receptor status of lesion is not required

               -  Prior invasive breast cancer

                    -  Breast cancer must have been surgically removed at time of original
                       diagnosis with no evidence of metastases

          -  No clinical evidence of breast cancer

          -  Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L2-L4
             postero-anterior (PA) spine and hip performed within past 6 months

               -  Bone mass density T-score of either PA spine or hip must be ≥ 2.0 SD below the
                  mean peak bone mass in young normal woman

          -  Stable chronic leukemia allowed

          -  Hormone receptor status:

               -  Hormone receptor-negative, -positive, or -equivocal tumor

        PATIENT CHARACTERISTICS:

        Age

          -  Postmenopausal

        Sex

          -  Female

        Menopausal status

          -  Postmenopausal, as defined by 1 of the following:

               -  Over 55 years of age with spontaneous cessation of menses for ≥ 1 year

               -  55 years of age and under with spontaneous cessation of menses for ≤ 1 year, but
                  amenorrheic (e.g., spontaneous or secondary to hysterectomy) AND
                  follicle-stimulating hormone level > 34.4 IU/L

               -  Bilateral oophorectomy

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Cardiovascular

          -  No recent unstable myocardial infarction

          -  No prior stroke

          -  No high blood pressure

          -  No other uncontrolled cardiovascular disease

        Other

          -  Other prior malignancies without metastatic disease allowed

          -  Willing and able to complete quality of life questionnaires in either English or
             French

          -  No uncontrolled metabolic or endocrine disease

          -  No malabsorption syndrome

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  No concurrent chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

          -  At least 3 months since prior and no concurrent hormone replacement therapy or
             raloxifene

          -  At least 6 months since prior tamoxifen

          -  No concurrent steroid therapy

          -  No concurrent selective estrogen-receptor modulators

          -  No other concurrent endocrine or hormonal therapy

        Radiotherapy

          -  Not specified

        Surgery

          -  See Disease Characteristics