Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280930
Status:
UNKNOWN
Last Update Posted:
2007-01-19
First Post:
2006-01-23
Brief Title:
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 tests6 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
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 tests6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCIC CTG MAP1 | None | None | None |