Breast Cancer Clinical Trial
Official title:
Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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