Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090857
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2004-09-07
Brief Title:
Letrozole in Preventing Breast Cancer in Postmenopausal Women
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISE
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels
PURPOSE This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels
PURPOSE This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels
Detailed Description:
OBJECTIVES
Primary
The primary outcome of the study is the change in bone mineral density following a year on letrozole vs a year on placebo
Secondary
Compare the safety acceptability and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms including hot flushes weight changes sexual functioning and genitourinary effects blood lipid levels markers of bone turnover and multidimensional quality of life
Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density
Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women
OUTLINE This is a pilot randomized double-blind placebo-controlled multicenter study Patients are randomized to 21 experimental treatment placebo arms
PROJECTED ACCRUAL A total of 110 patients 73 for arm I and 37 for arm II will be accrued for this study
Primary
The primary outcome of the study is the change in bone mineral density following a year on letrozole vs a year on placebo
Secondary
Compare the safety acceptability and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms including hot flushes weight changes sexual functioning and genitourinary effects blood lipid levels markers of bone turnover and multidimensional quality of life
Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density
Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women
OUTLINE This is a pilot randomized double-blind placebo-controlled multicenter study Patients are randomized to 21 experimental treatment placebo arms
PROJECTED ACCRUAL A total of 110 patients 73 for arm I and 37 for arm II will be accrued for this study
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 |
|---|---|---|---|
| P50CA089393 | NIH | None | None |
| P30CA006516 | NIH | None | None |
| DFCI-00024 | None | None | None |
| UCLA-0210012-02 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |