Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005886
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2000-06-02
Brief Title:
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
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 Estrogen can stimulate the growth of breast cancer cells Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen
PURPOSE This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue compared with LY353381 in treating women with newly diagnosed breast cancer
PURPOSE This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue compared with LY353381 in treating women with newly diagnosed breast cancer
Detailed Description:
OBJECTIVES
Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer
OUTLINE This is a randomized double-blind placebo-controlled multicenter study
Phase I Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily
Upon completion of phase I all treatment centers begin phase II of the study
Phase II Patients are randomized to receive either oral tamoxifen or oral placebo daily
Treatment in both phases continues for 2-6 weeks until scheduled lumpectomy or mastectomy in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 and 2 weeks after surgery
PROJECTED ACCRUAL A minimum of 120 patients 60 per treatment phase will be accrued for this study within 18 months
Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer
OUTLINE This is a randomized double-blind placebo-controlled multicenter study
Phase I Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily
Upon completion of phase I all treatment centers begin phase II of the study
Phase II Patients are randomized to receive either oral tamoxifen or oral placebo daily
Treatment in both phases continues for 2-6 weeks until scheduled lumpectomy or mastectomy in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 and 2 weeks after surgery
PROJECTED ACCRUAL A minimum of 120 patients 60 per treatment phase will be accrued for this study within 18 months
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 |
|---|---|---|---|
| KUMC-7813-99 | None | None | None |
| KUMC-HSC-7419-98 | None | None | None |
| NCI-P00-0158 | None | None | None |