indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer

Conditions: Breast Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. indole-3-carbinol may be effective in preventing breast cancer. purpose: phase i trial to study the effectiveness of indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer.

objectives: * determine the safety and tolerability of indole-3-carbinol for the prevention of breast cancer in non-smoking women at high risk for breast cancer. * determine the pharmacokinetics of this drug in these participants. * determine the effect of this drug on metabolites of estrogen in urine of these participants. * determine other additional effects of this drug on selected indicators of drug metabolism and reproductive and hormonal function in these participants. * assess any possible antineoplastic activity of this drug in these participants. * determine the quality of life of participants receiving this drug. outline: this is a single-blind study. participants ingest study compound twice daily on weeks 1-12 or 1-16. study compound is dispensed on weeks 1, 5, and 9. at times, study compound is oral placebo, and at other times, oral indole-3-carbinol. quality of life is assessed at baseline and then every 4 weeks during study therapy. projected accrual: a total of 18 participants will be accrued for this study within 9 months.

Eligibility criteria:
disease characteristics: * women at high risk for breast cancer, defined by at least 1 of the following criteria: * projected 5-year probability of invasive breast cancer at least 1.66%, as determined by the breast cancer risk assessment tool * prior node-negative breast cancer * prior biopsy indicating atypical lobular or ductal hyperplasia or carcinoma in situ * age 60 and over * non-smoker confirmed by urine cotinine test * no concurrent breast cancer * hormone receptor status: * not specified patient characteristics: age: * 18 to 70 sex: * female menopausal status: * premenopausal (regular menstrual cycles of 24-36 days within the past 6 months) or * postmenopausal (no menstrual cycle for at least 6 months) performance status: * not specified life expectancy: * at least 1 year hematopoietic: * absolute granulocyte count greater than 1,500/mm\^3 * hemoglobin greater than 10 g/dl hepatic: * bilirubin less than 1.8 mg/dl * aspartate aminotransferase (ast) and alanine transaminase (alt) less than 110 u/l * alkaline phosphatase less than 300 u/l * albumin greater than 3 g/dl renal: * creatinine less than 2.0 mg/dl cardiovascular: * no acute or unstable cardiovascular condition based on electrocardiogram other: * mild seasonal allergies allowed * no serious or life-threatening drug allergies * no other serious intolerances or allergies * no more than 20% above or below ideal body weight * no acute or unstable medical condition by physical examination or laboratory tests * no chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions * no serious illness requiring chronic drug therapy * no active malignancy * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception 1 month before, during, and for 1 month after study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * at least 2 months since prior hormonal therapy as contraception or hormone replacement therapy (hrt) * no concurrent sex hormones as contraception for premenopausal women * no concurrent hrt for postmenopausal women radiotherapy: * not specified surgery: * not specified other: * at least 6 months since prior investigational drugs * at least 1 month since prior weekly consumption of more than 3 medium servings (half cup each) of cruciferous vegetables * no concurrent vegetarian diet or weekly consumption of more than 3 medium servings (half cup each) of cruciferous vegetables * no continuous supplement intake * no recent change in medications or dosage of medications

Keywords: breast cancer