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

August 17, 2016 updated by: University of Kansas Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160-7320
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Indole-3-carbinol
400 mg pill taken daily
Other Names:
  • I3C
Drug: Indole-3-carbinol
800 mg pill taken daily
Other Names:
  • I3C
Other: Placebo
Placebo pill taken daily during run-in period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Aryeh Hurwitz, MD, University of Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 9, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUMC-8508-01
  • CDR0000069276 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-P02-0217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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