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

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ClinicalTrials.gov Identifier: NCT00033345
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Indole-3-carbinol Other: Placebo Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol
Study Start Date : January 2002
Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: High-Risk Breast Cancer
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
400 mg pill taken daily
Other Name: I3C
Drug: Indole-3-carbinol
800 mg pill taken daily
Other Name: I3C
Other: Placebo
Placebo pill taken daily during run-in period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 70


  • 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


  • Absolute granulocyte count greater than 1,500/mm^3
  • Hemoglobin greater than 10 g/dL


  • 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


  • Creatinine less than 2.0 mg/dL


  • No acute or unstable cardiovascular condition based on electrocardiogram


  • 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


Biologic therapy:

  • Not specified


  • 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


  • Not specified


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033345

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7320
Sponsors and Collaborators
University of Kansas Medical Center
National Cancer Institute (NCI)
Study Chair: Aryeh Hurwitz, MD University of Kansas

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00033345     History of Changes
Other Study ID Numbers: KUMC-8508-01
CDR0000069276 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by University of Kansas Medical Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents