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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: goserelin acetate
* Drug: raloxifene


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: High genetic risk of developing breast cancer defined as one or more of the following: BRCA1 or BRCA2 germ-line mutation First-degree relative of known BRCA1 or BRCA2 mutation carrier Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60 Two first-degree relatives diagnosed with breast cancer before the age of 40 p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only) First-degree relative of a carrier in a family with classical LFS Risk equivalent to any of the above confirmed by clinical geneticist No evidence of breast cancer by mammography Suspicious lesions must be confirmed as non-malignant No prior breast cancer No prior prophylactic mastectomy No plan for alternative prevention measures within the next 12 months Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 30 to 45 Sex: Female Menopausal status: Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating) Performance status: Not specified Life expectancy: More than 10 years (excluding breast cancer risk) Hematopoietic: Not specified Hepatic: Adequate liver function Renal: Adequate renal function Cardiovascular: No prior deep vein thrombosis Pulmonary: No prior pulmonary embolism Other: Not pregnant Fertile patients must use effective nonhormonal contraception No psychological disorder that would preclude study compliance No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy) Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days or 5 half-lives since prior investigational drugs No concurrent anticoagulants

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: goserelin acetate|nan|
|Drug: raloxifene|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer