Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019500
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Raloxifene in Preventing Breast Cancer in Premenopausal Women
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-04
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 raloxifene may be an effective way to prevent breast cancer in premenopausal women
PURPOSE Phase II trial to study the effectiveness of raloxifene in preventing invasive breast cancer in premenopausal women
PURPOSE Phase II trial to study the effectiveness of raloxifene in preventing invasive breast cancer in premenopausal women
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of raloxifene in premenopausal women at high risk of developing invasive breast cancer
Determine the effect of raloxifene on blood steroid hormone levels luteinizing hormone estradiol progesterone and carotenoid levels during the menstrual cycle in these participants
Determine the effect of raloxifene on the endometrium and ovaries in these participants
Determine the effect of raloxifene on biochemical markers of bone metabolism lipid profiles and fibrinogen in these participants
Determine the effect of raloxifene on health-related quality of life of these participants
Determine the effect of raloxifene on bone mineral density in the spine and hip of these participants
OUTLINE This is an open-label study
Participants are medically evaluated followed by an observation period of 1 to 2 menstrual cycles After the observation period participants receive oral raloxifene once daily for 2 years
Quality of life is assessed 1 week prior to study drug administration and at 6 12 24 and 36 months after study drug administration
Participants are followed for 1 year
PROJECTED ACCRUAL A total of 41 participants will be accrued for this study within 3 years
Determine the safety and tolerability of raloxifene in premenopausal women at high risk of developing invasive breast cancer
Determine the effect of raloxifene on blood steroid hormone levels luteinizing hormone estradiol progesterone and carotenoid levels during the menstrual cycle in these participants
Determine the effect of raloxifene on the endometrium and ovaries in these participants
Determine the effect of raloxifene on biochemical markers of bone metabolism lipid profiles and fibrinogen in these participants
Determine the effect of raloxifene on health-related quality of life of these participants
Determine the effect of raloxifene on bone mineral density in the spine and hip of these participants
OUTLINE This is an open-label study
Participants are medically evaluated followed by an observation period of 1 to 2 menstrual cycles After the observation period participants receive oral raloxifene once daily for 2 years
Quality of life is assessed 1 week prior to study drug administration and at 6 12 24 and 36 months after study drug administration
Participants are followed for 1 year
PROJECTED ACCRUAL A total of 41 participants will be accrued for this study within 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 |
|---|---|---|---|
| MB-402 | None | None | None |
| NCI-98-C-0123 | None | None | None |