Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For 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. 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.

Detailed Description
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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.

Official Title
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Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Indole-3-carbinol
* Drug: Indole-3-carbinol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Risk Breast Cancer<br>All subjects first went through a 4-week placebo run-in period. Next, subjects took Indole-3-carbinol 400mg daily for 4 weeks followed by a 4-week period of Indole-3-carbinol 800mg daily. | Drug: Indole-3-carbinol<br>* 400 mg pill taken daily<br>* Other names: I3C;Drug: Indole-3-carbinol<br>* 800 mg pill taken daily<br>* Other names: I3C;Other: Placebo<br>* Placebo pill taken daily during run-in period<br>|

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