Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
|ClinicalTrials.gov Identifier: NCT00280930|
Recruitment Status : Unknown
Verified January 2007 by Dana-Farber Cancer Institute.
Recruitment status was: Active, not recruiting
First Posted : January 24, 2006
Last Update Posted : January 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Post-Menopausal Breast Cancer||Drug: Letrozole||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|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|
|Study Start Date :||October 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280930
|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|