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A Multicenter Randomized Double-Blind Trial Of Targretin Capsules Modifying Immunophenotypic Markers Related To Breast Cancer Progression In Breast Tissue From Genetically Identified High Risk Patients

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Multicenter Randomized Double-Blind Trial Of Targretin Capsules Modifying Immunophenotypic Markers Related To Breast Cancer Progression In Breast Tissue From Genetically Identified High Risk Patients


- Determine whether bexarotene can modify immunophenotypic markers related to breast
cancer progression in women at high genetic risk for breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to menopausal status (women with a uterus who have not had a
menstrual period for more than 1 year vs any woman over 55 years old vs women 55 years and
under without a uterus whose follicle-stimulating hormone is in the postmenopausal range).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral bexarotene once daily on days 1-28.

- Arm II: Patients receive oral placebo as in arm I. In both arms, treatment continues in
the absence of unacceptable toxicity or elevation of triglycerides to greater than 800
mg/dL. Patients undergo 2 breast biopsies in the same location on days 1 and 29.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 4 years.

Inclusion Criteria


- Known carrier of a BRCA-1 or BRCA-2 mutation

- Copy of laboratory report stating results must be available for review OR

- At risk for carrying a BRCA-1 or BRCA-2 mutation

- At least 10% risk by Parmigiana probability model

- Must have at least 1 breast that has never been involved with cancer and has not been

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified


- WBC greater than 4,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hematocrit greater than 30%


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 1.5 times ULN

- Alkaline phosphatase no greater than 1.5 times ULN

- Albumin no greater than 1.5 times ULN

- No biliary tract disease


- Creatinine no greater than 1.5 times ULN


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 1 month before, during, and for
1 month after study therapy

- Triglycerides normal

- Thyroid-stimulating hormone and thyroxine normal

- Willing to undergo 2 duplicate needle biopsies of the breast

- Willing to undergo genetic testing for BRCA-1 and BRCA-2

- No uncontrolled hyperlipidemia

- No nontoxic goiter or thyroid enlargement

- No severe underlying chronic illness or disease

- No uncontrolled diabetes

- No history of pancreatitis

- No cancer within the past year except skin cancer or carcinoma in situ of the cervix
(defined from the date of first diagnosis)

- No concurrent alcohol use (greater than 3 drinks or its equivalent per day)


Biologic therapy

- Not specified


- More than 1 year since prior chemotherapy for a neoplasm

Endocrine therapy

- More than 3 months since prior postmenopausal hormonal therapy (including estrogens
or progestins)

- More than 3 months since prior tamoxifen or other selective estrogen-receptor

- No concurrent hormone replacement therapy

- Concurrent thyroid hormone supplementation allowed


- See Disease Characteristics


- Not specified


- More than 30 days since prior investigational medications

- More than 3 months since prior oral vitamin A supplements greater than the
recommended daily requirement (5,000 IU) or therapeutic oral or topical vitamin A
derivatives (e.g., isotretinoin)

- No concurrent participation in a study of an investigational agent

- No concurrent medications known to be associated with pancreatic toxicity or to
increase triglyceride levels

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Chemopreventive effect as determine by a modification of the immunophenotypic characteristics of normal breast tissue at day 29 during study treatment and day 30 after study completion

Safety Issue:


Principal Investigator

Richard M. Elledge, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

September 2006

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms



M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Cancer Therapy and Research Center San Antonio, Texas  78229
Dan L. Duncan Cancer Center at Baylor College of Medicine Houston, Texas  77030