Breast Cancer Clinical Trial
Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high breast density.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.
Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole for 1 year.
Determine whether a decrease in breast density grade is sustained at 1 year in patients treated with this drug.
Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline in these patients.
Determine the percentage of patients with breast tissue hyperplasia and atypical hyperplasia, as assessed by histopathological examination of breast tissue biopsies, before and after treatment with this drug.
Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after cessation of this drug in these patients.
Compare changes in predetermined specific parameters of safety at the end of 1 year of treatment with this drug with baseline evaluations of these patients.
Determine whether modifications of these predetermined specific parameters of safety are sustained 1 year after cessation of treatment with this drug in these patients.
Determine the general safety of 1 year of treatment with this drug in these patients.
Compare the effects of this drug on menopause-specific quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to breast density grade (4/6 vs 5/6 vs 6/6). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral letrozole once daily for 1 year in the absence of unacceptable toxicity.
Arm II: Patients receive oral placebo once daily for 1 year in the absence of unacceptable toxicity.
Menopause-specific quality of life is assessed at baseline and then at 12 and 24 months.
After completion of study treatment, patients are followed at 6 months and 1 year.
PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study within 12 months.
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
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
No recent unstable myocardial infarction
No prior stroke
No high blood pressure
No other uncontrolled cardiovascular disease
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:
No concurrent immunotherapy
No concurrent chemotherapy
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
See Disease Characteristics
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There are 10 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Calgary Alberta, T2N 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8N 1, Canada
Ottawa Ontario, K1H 8, Canada
St. Catharines Ontario, L2R 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2W 1, Canada
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