NCT00033345

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

6.5 years

First QC Date

April 9, 2002

Last Update Submit

August 17, 2016

Conditions

Breast Cancer

Keywords

breast cancer

Study Arms (1)

High-Risk Breast Cancer

EXPERIMENTAL

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-carbinolOther: Placebo

Interventions

Indole-3-carbinolDRUG

400 mg pill taken daily

Also known as: I3C
High-Risk Breast Cancer
PlaceboOTHER

Placebo pill taken daily during run-in period

High-Risk Breast Cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160-7320, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

indole-3-carbinol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aryeh Hurwitz, MD

    University of Kansas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

July 1, 2008

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations

US(1)