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

Breast Cancer Clinical Trial

Official title:

Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033345
• Other study ID #: KUMC-8508-01
• Secondary ID: CDR0000069276NCI
• Status: Completed
• Phase: Phase 1
• First received: April 9, 2002
• Last updated: August 17, 2016
• Start date: January 2002

Study information

• Verified date: August 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Indole-3-carbinol
400 mg pill taken daily
• Indole-3-carbinol
800 mg pill taken daily

Other:
• Placebo
Placebo pill taken daily during run-in period

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,