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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Indole-3-carbinol

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