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
- 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
- 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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Change in breast density as measured by Boyd Scale at 1 year
Paul E. Goss, MD, PhD
Massachusetts General Hospital
United States: Federal Government
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Memorial Hospital of Rhode Island||Pawtucket, Rhode Island 02860|