Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055991
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2003-03-06
Brief Title:
Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
Sponsor:
Baylor Breast Care Center
Organization:
Baylor Breast Care Center
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Trial Of Targretin Capsules Modifying Immunophenotypic Markers Related To Breast Cancer Progression In Breast Tissue From Genetically Identified High Risk Patients
Status:
COMPLETED
Status Verified Date:
2013-02
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 Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer It is not yet known whether bexarotene is effective in preventing breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of bexarotene in preventing breast cancer in women who are at genetic risk of developing breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of bexarotene in preventing breast cancer in women who are at genetic risk of developing breast cancer
Detailed Description:
OBJECTIVES
Determine whether bexarotene can modify immunophenotypic markers related to breast cancer progression in women at high genetic risk for breast cancer
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to menopausal status women with a uterus who have not had a menstrual period for more than 1 year vs any woman over 55 years old vs women 55 years and under without a uterus whose follicle-stimulating hormone is in the postmenopausal range Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral bexarotene once daily on days 1-28
Arm II Patients receive oral placebo as in arm I In both arms treatment continues in the absence of unacceptable toxicity or elevation of triglycerides to greater than 800 mgdL Patients undergo 2 breast biopsies in the same location on days 1 and 29
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 4 years
Determine whether bexarotene can modify immunophenotypic markers related to breast cancer progression in women at high genetic risk for breast cancer
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to menopausal status women with a uterus who have not had a menstrual period for more than 1 year vs any woman over 55 years old vs women 55 years and under without a uterus whose follicle-stimulating hormone is in the postmenopausal range Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral bexarotene once daily on days 1-28
Arm II Patients receive oral placebo as in arm I In both arms treatment continues in the absence of unacceptable toxicity or elevation of triglycerides to greater than 800 mgdL Patients undergo 2 breast biopsies in the same location on days 1 and 29
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 4 years
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 |
|---|---|---|---|
| 5U19CA086809 | NIH | None | httpsreporternihgovquickSearch5U19CA086809 |