Clinical trial · Interventional
Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol
NCT00033345CI-TRIAL-00023552completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indole-3-carbinol | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-Risk Breast Cancer
- description
- 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.
- interventionNames
- Drug: Indole-3-carbinol
- Other: Placebo
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.