Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
Recruitment status was Active, not recruiting
The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density|
- To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.
- To determine if the decrease in breast density grade is sustained one year after cessation of therapy
- to determine if there is a correlation between plasma estrogen profile and breast density at baseline
- to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy
- to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy
- to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year
- to compare the effects on menopause-specific quality of life.
|Study Start Date:||October 2005|
- Patients will be randomized into one of two study groups. Group 1 will receive letrozole and Group 2 will receive placebo. This is a double-blind trial so neither the patient or the doctor will know what treatment group they are assigned to.
- If the patient is in Group 1 they will take letrozole tablets orally once a day with food for one year. Patients in Group 2 will take a placebo tablet orally once a day with food for one year.
- Patients in both groups will also be given calcium tablets (500mg) and vitamin D tablets (400IU) once a day for one year.
- After the initial screening visits, the patient will return to the clinic at 3, 6, 9 and 12 months (a total of up to 6 visits in the first year). There will also be two follow-up visits at 18 and 24 months. For the 3, 9 and 18 month visits, telephone contact instead of a clinic visit is allowed.
- The following tests and procedures will be performed during these visits:
evaluation of side effects; routine blood tests(6, 12, and 24 month visits); urine sample (6 and 12 month visits); complete physical exam including breast exam (12 and 24 month visits); mammogram (12 and 24 month visits); bone marrow density x-ray test (12 and 24 month visits); standard x-rays of the lower back and chest (12 month visit); and a questionnaire about how the patient is feeling (12 and 24 month visits).
- The length of participation in this study is for 1 year of study treatment followed by 1 year of follow-up.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Paul Goss, MD, PhD||Massachusetts General Hospital|