Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005879
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2000-06-02
Brief Title:
LY353381 in Preventing Breast Cancer in Women With Hyperplasia
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator LY353381HCl in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia
Status:
COMPLETED
Status Verified Date:
2017-04
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 is the use of certain drugs to try to prevent the development or recurrence of cancer The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia
PURPOSE Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia
PURPOSE Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia
Detailed Description:
OBJECTIVES
Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer
Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers
Determine if cytologic improvement is associated with initial presentation of the various stratification factors
Determine whether cytology is correlated with other potential surrogate endpoint biomarkers or drug effect biomarkers and whether change in cytology is correlated with change in the other biomarkers
Monitor the effects of this drug in terms of quality of life and womens health
OUTLINE This is a randomized double-blind multicenter study followed by an open-label study for both arms Patients are stratified according to cytologic status hyperplasia with atypia vs hyperplasia without atypia mutation status known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes menopausal status premenopausal vs postmenopausal estrogen-receptor status and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive oral LY353381 hydrochloride once daily for 6 months
Arm II Patients receive oral placebo once daily for 6 months Patients in both arms then receive oral LY353381 hydrochloride for an additional 6 months
Quality of life is assessed at baseline and then at 6 and 12 months
Patients are followed at 2 weeks and then annually for 5 years
PROJECTED ACCRUAL A total of 210-220 patients will be accrued for this study within 25-3 years
Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer
Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers
Determine if cytologic improvement is associated with initial presentation of the various stratification factors
Determine whether cytology is correlated with other potential surrogate endpoint biomarkers or drug effect biomarkers and whether change in cytology is correlated with change in the other biomarkers
Monitor the effects of this drug in terms of quality of life and womens health
OUTLINE This is a randomized double-blind multicenter study followed by an open-label study for both arms Patients are stratified according to cytologic status hyperplasia with atypia vs hyperplasia without atypia mutation status known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes menopausal status premenopausal vs postmenopausal estrogen-receptor status and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive oral LY353381 hydrochloride once daily for 6 months
Arm II Patients receive oral placebo once daily for 6 months Patients in both arms then receive oral LY353381 hydrochloride for an additional 6 months
Quality of life is assessed at baseline and then at 6 and 12 months
Patients are followed at 2 weeks and then annually for 5 years
PROJECTED ACCRUAL A total of 210-220 patients will be accrued for this study within 25-3 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 |
|---|---|---|---|
| U01CA077165 | NIH | NCI | httpsreporternihgovquickSearchU01CA077165 |
| CDR0000067918 | REGISTRY | None | None |
| NCI-P00-0146 | OTHER | None | None |