Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-30 @ 5:02 AM
Study NCT ID:
NCT00031850
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer
Sponsor:
Institute of Cancer Research, United Kingdom
Organization:
Study Overview
Official Title:
A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-05
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 and goserelin may be effective in preventing breast cancer.
PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.
PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.
Detailed Description:
OBJECTIVES:
* Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.
* Compare the incidence of adverse effects in patients treated with these regimens.
* Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.
* Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
* Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.
* Compare the incidence of adverse effects in patients treated with these regimens.
* Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.
* Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: