Raloxifene in Preventing Breast Cancer in Premenopausal Women

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 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.

Detailed Description
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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.

Official Title
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A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: raloxifene
* Procedure: evaluation of cancer risk factors


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: At risk for developing invasive breast cancer by virtue of 1 of the following criteria: Gail model risk equal to that of an average 60 year old woman as determined using the Gail risk assessment model Lobular neoplasia Atypical ductal hyperplasia with a positive family history of breast cancer Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and radiation BRCA1 or BRCA2 mutation-positive genotyping Family history consistent with hereditary cancer syndrome of increased breast cancer risk defined as 1 of the following: Family with more than 2 breast cancer cases and one or more cases of ovarian cancer diagnosed at any age Family with more than 3 breast cancer cases diagnosed before age 50 Sister pairs with 2 breast cancers, 2 ovarian cancers, or 1 breast and 1 ovarian cancer diagnosed before age 50 Premenopausal Menstrual cycle of 26-35 days No change in menstrual pattern within the past 6 months (no irregularities) FSH level less than 20 mIU/mL Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 23 to 47 Sex Female Menopausal status Premenopausal Performance status Not specified Life expectancy Not specified Hematopoietic No history of bleeding disorder Hepatic No history of cirrhosis of the liver SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Renal Creatinine no greater than 1.7 mg/dL Cardiovascular No history of pulmonary embolism or deep venous thrombosis Other Not pregnant or nursing Negative pregnancy test Fertile participants must use effective non-hormonal contraception (e.g. barrier methods, spermicides, or surgical methods) during and for 3 months after study No history of infertility with a suspected ovarian etiology or recurrent ovarian cysts No allergy to raloxifene No dysfunctional uterine bleeding No menorrhagia No cervical dysplasia or significant uterine pathology requiring concurrent surgery No medical or psychiatric disorder that would preclude study participation Normal CA 125 levels PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy At least 6 months since prior steroid therapy (e.g., tamoxifen, estrogen, DHEA, anabolic steroids, or oral contraceptives) Radiotherapy See Disease Characteristics Surgery See Disease Characteristics No prior hysterectomy

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 47 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: raloxifene|nan|
|Procedure: evaluation of cancer risk factors|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