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

NCT ID: NCT00033345

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Indole-3-carbinol

Intervention Type: DRUG

400 mg pill taken daily

Indole-3-carbinol

Intervention Type: DRUG

800 mg pill taken daily

Placebo

Intervention Type: OTHER

Placebo pill taken daily during run-in period

Interventions

Indole-3-carbinol

400 mg pill taken daily

Intervention Type: DRUG

Indole-3-carbinol

800 mg pill taken daily

Intervention Type: DRUG

Placebo

Placebo pill taken daily during run-in period

Intervention Type: OTHER

Other Intervention Names

I3C; I3C

Eligibility Criteria

Inclusion 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aryeh Hurwitz, MD

Role: STUDY_CHAIR

University of Kansas

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

CDR0000069276

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-P02-0217

Identifier Type: -

Identifier Source: secondary_id

KUMC-8508-01

Identifier Type: -

Identifier Source: org_study_id