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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indole-3-carbinol
Indole-3-carbinol
Placebo
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-Risk Breast Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 9, 2002
Last Updated
August 17, 2016
Sponsor
University of Kansas Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033345
Brief Title
Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
Official Title
Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Risk Breast Cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indole-3-carbinol
Other Intervention Name(s)
I3C
Intervention Description
400 mg pill taken daily
Intervention Type
Drug
Intervention Name(s)
Indole-3-carbinol
Other Intervention Name(s)
I3C
Intervention Description
800 mg pill taken daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pill taken daily during run-in period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aryeh Hurwitz, MD
Organizational Affiliation
University of Kansas
Official's Role
Study Chair
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7320
Country
United States

12. IPD Sharing Statement

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

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