Breast Cancer Clinical Trial
Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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)
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There are 11 Locations for this study
Jacksonville Florida, 32224, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Columbus Ohio, 43210, United States
Pawtucket Rhode Island, 02860, United States
Hamilton Ontario, L8V 5, Canada
Thunder Bay Ontario, P7B 6, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2L-4, Canada
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