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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033345
First received: April 9, 2002
Last updated: July 23, 2008
Last verified: March 2003
  Purpose

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 Intervention Phase
Breast Cancer
Drug: indole-3-carbinol
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • AST and 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033345

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7320
Sponsors and Collaborators
University of Kansas
Investigators
Study Chair: Aryeh Hurwitz, MD University of Kansas
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00033345     History of Changes
Other Study ID Numbers: CDR0000069276, KUMC-8508-01, NCI-P02-0217
Study First Received: April 9, 2002
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Indole-3-carbinol
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014