Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00031850
• Lead Sponsor: Institute of Cancer Research, United Kingdom

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.

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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2002-03-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-05
• Study Completion: 2007-05
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Christie Hospital NHS Trust; 🇬🇧 Manchester, England, United Kingdom