A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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.
Paul Goss, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|