You are viewing an expired study

This study is not currently recruiting Study Participants on If you would like to find active studies please browse nearby listings below.

Click here to view additional nearby studies or search for clinical trials.

Kansas City, Kansas 66160

  • Breast Cancer


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Aryeh Hurwitz, MD
University of Kansas Medical Center

Backup Contact:


Location Contact:

Kansas City, Kansas 66160
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: April 07, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on The form below is not enabled.