Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
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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.
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Determine whether the decrease in breast density is sustained 1 year after the cessation of this drug in these participants.
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Correlate the grade of breast density with bone density at baseline and at 1 year in participants treated with this drug.
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Determine the overall safety of this drug, in terms of bone and lipid metabolism and toxicity, in these participants.
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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.
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Arm I: Participants receive oral exemestane once daily for 1 year.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Exemestane
|
Drug: exemestane
exemestane 25 mg once daily x 1 year
|
| Placebo Comparator: Placebo
|
Drug: Placebo
placebo once daily x 1 year
|
Outcome Measures
Primary Outcome Measures
- Change in breast density as measured by Boyd Scale at 1 year [6 years]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Radiologically confirmed density occupying at least 25% of the breast tissue on baseline mammogram*
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Grade 2, 3, 4, 5, or 6 (Boyd classification)
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Participants with different grades between the 2 breasts should be classified according to a higher grade NOTE: *Performed within 6 months before study entry
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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
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No concurrent breast cancer
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No prior invasive breast cancer or ductal carcinoma in situ
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No breast implants
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Hormone receptor status:
-
Not specified
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
Menopausal status
-
Postmenopausal, defined as 1 of the following:
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Over 50 years of age with no spontaneous menses for at least 1 year
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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
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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
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No uncontrolled metabolic or endocrine disease
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No malabsorption syndrome
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No known hypersensitivity to exemestane or its excipients
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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
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More than 3 months since prior exogenous estrogen and/or progesterone/progestin therapy
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More than 6 months since prior selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
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No concurrent selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
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No concurrent steroids
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Vaginal estrogens allowed (e.g., Estring® or Vagifem®)
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No concurrent compounded creams
Radiotherapy
- Not specified
Surgery
- Not specified
Other
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More than 4 weeks since prior investigational agents
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No other concurrent medications that would preclude study endpoints
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No concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:
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Ginseng
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Ginkgo biloba
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Black cohosh
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Dong quai
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Fortified soy supplements (e.g., phytoestrogen preparations)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
| 2 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 3 | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 4 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 5 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02215 |
| 6 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 7 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | United States | 43210-1240 |
| 8 | Memorial Hospital of Rhode Island | Pawtucket | Rhode Island | United States | 02860 |
| 9 | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 10 | Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada | P7B 6V4 |
| 11 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 12 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2L-4M1 |
Sponsors and Collaborators
- NCIC Clinical Trials Group
Investigators
- Study Chair: Paul E. Goss, MD, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAP2
- CAN-NCIC-MAP2
- PFIZER-971-ONC-0028-088
- CDR0000316328
- NCT00258648