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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014