Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00066586|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : June 3, 2013
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|
|Breast Cancer||Drug: exemestane Drug: Placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||February 2009|
|Active Comparator: Exemestane||
exemestane 25 mg once daily x 1 year
|Placebo Comparator: Placebo||
placebo once daily x 1 year
- Change in breast density as measured by Boyd Scale at 1 year [ Time Frame: 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066586
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, Rhode Island|
|Memorial Hospital of Rhode Island|
|Pawtucket, Rhode Island, United States, 02860|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L-4M1|
|Study Chair:||Paul E. Goss, MD, PhD||Massachusetts General Hospital|