Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Exemestane may be effective in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density. PURPOSE: Randomized clinical trial to study the effectiveness of exemestane in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density in postmenopausal women who are at increased risk for breast cancer.

Detailed Description
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OBJECTIVES: Determine the efficacy of exemestane in decreasing breast density at least 1 grade in postmenopausal women with increased radiological breast density at increased risk for breast cancer. Determine whether the decrease in breast density is sustained 1 year after the cessation of this drug in these participants. Correlate the grade of breast density with bone density at baseline and at 1 year in participants treated with this drug. Determine the overall safety of this drug, in terms of bone and lipid metabolism and toxicity, in these participants. Determine the menopause-specific quality of life of participants treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to baseline mammographic density grade (2 vs 3 vs 4 vs 5 vs 6). Participants are randomized to 1 of 2 treatment arms. Arm I: Participants receive oral exemestane once daily for 1 year. Arm II: Participants receive oral placebo once daily for 1 year. In both arms, treatment continues in the absence of disease or unacceptable toxicity. Quality of life is assessed at baseline and then at 3, 6, 9, 12, 18, and 24 months. Participants are followed at 18 and 24 months. PROJECTED ACCRUAL: A total of 120 participants (60 per treatment arm) will be accrued for this study.

Official Title
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A Randomized Study Of The Effect Of Exemestane (Aromasin) Versus Placebo On Breast Density In Postmenopausal Women At Increased Risk For Development Of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: exemestane
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Radiologically confirmed density occupying at least 25% of the breast tissue on baseline mammogram* Grade 2, 3, 4, 5, or 6 (Boyd classification) Participants with different grades between the 2 breasts should be classified according to a higher grade NOTE: *Performed within 6 months before study entry Bone mineral density T-score of either posterior-anterior spine or hip (femoral neck) must be no greater than 2.0 standard deviations below the mean value of peak bone mass in young normal women as determined by DEXA scan within the past 6 months No concurrent breast cancer No prior invasive breast cancer or ductal carcinoma in situ No breast implants Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Postmenopausal Sex Female Menopausal status Postmenopausal, defined as 1 of the following: Over 50 years of age with no spontaneous menses for at least 1 year 50 years of age and under with no menses (e.g., spontaneous or secondary to hysterectomy) within the past year AND a follicle-stimulating hormone level within institution postmenopausal range Bilateral oophorectomy Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No cardiovascular disease No history of myocardial infarction No history of stroke No uncontrolled high blood pressure Other No uncontrolled metabolic or endocrine disease No malabsorption syndrome No known hypersensitivity to exemestane or its excipients No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy No concurrent immunotherapy Chemotherapy No prior chemotherapy No concurrent chemotherapy Endocrine therapy More than 3 months since prior exogenous estrogen and/or progesterone/progestin therapy More than 6 months since prior selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene) No concurrent selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene) No concurrent steroids Vaginal estrogens allowed (e.g., Estring® or Vagifem®) No concurrent compounded creams Radiotherapy Not specified Surgery Not specified Other More than 4 weeks since prior investigational agents No other concurrent medications that would preclude study endpoints No concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following: Ginseng Ginkgo biloba Black cohosh Dong quai Fortified soy supplements (e.g., phytoestrogen preparations)

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exemestane<br> | Drug: exemestane<br>* exemestane 25 mg once daily x 1 year<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo once daily x 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breast density as measured by Boyd Scale at 1 year |  | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer