Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066586
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2003-08-06
Brief Title:
Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Study Of The Effect Of Exemestane Aromasin Versus Placebo On Breast Density In Postmenopausal Women At Increased Risk For Development Of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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:
None
Brief Summary:
RATIONALE High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer Exemestane may be effective in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density
PURPOSE Randomized clinical trial to study the effectiveness of exemestane in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density in postmenopausal women who are at increased risk for breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of exemestane in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density in postmenopausal women who are at increased risk for breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of exemestane in decreasing breast density at least 1 grade in postmenopausal women with increased radiological breast density at increased risk for breast cancer
Determine whether the decrease in breast density is sustained 1 year after the cessation of this drug in these participants
Correlate the grade of breast density with bone density at baseline and at 1 year in participants treated with this drug
Determine the overall safety of this drug in terms of bone and lipid metabolism and toxicity in these participants
Determine the menopause-specific quality of life of participants treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Participants are stratified according to baseline mammographic density grade 2 vs 3 vs 4 vs 5 vs 6 Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral exemestane once daily for 1 year
Arm II Participants receive oral placebo once daily for 1 year In both arms treatment continues in the absence of disease or unacceptable toxicity
Quality of life is assessed at baseline and then at 3 6 9 12 18 and 24 months
Participants are followed at 18 and 24 months
PROJECTED ACCRUAL A total of 120 participants 60 per treatment arm will be accrued for this study
Determine the efficacy of exemestane in decreasing breast density at least 1 grade in postmenopausal women with increased radiological breast density at increased risk for breast cancer
Determine whether the decrease in breast density is sustained 1 year after the cessation of this drug in these participants
Correlate the grade of breast density with bone density at baseline and at 1 year in participants treated with this drug
Determine the overall safety of this drug in terms of bone and lipid metabolism and toxicity in these participants
Determine the menopause-specific quality of life of participants treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Participants are stratified according to baseline mammographic density grade 2 vs 3 vs 4 vs 5 vs 6 Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral exemestane once daily for 1 year
Arm II Participants receive oral placebo once daily for 1 year In both arms treatment continues in the absence of disease or unacceptable toxicity
Quality of life is assessed at baseline and then at 3 6 9 12 18 and 24 months
Participants are followed at 18 and 24 months
PROJECTED ACCRUAL A total of 120 participants 60 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000316328 | OTHER | PDQ | None |
| CAN-NCIC-MAP2 | OTHER | None | None |
| PFIZER-971-ONC-0028-088 | OTHER | None | None |