Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00055991
First received: March 6, 2003
Last updated: February 4, 2013
Last verified: February 2013

March 6, 2003
February 4, 2013
September 2001
September 2006   (final data collection date for primary 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 [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00055991 on ClinicalTrials.gov Archive Site
Apoptosis at day 29 during study treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
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

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether bexarotene is effective in preventing breast cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of bexarotene in preventing breast cancer in women who are at genetic risk of developing breast cancer.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Breast Cancer
Drug: bexarotene
This drug is a retinoid. The anti-tumor action of retinoids, as well as their potential in chemoprevention, supports the need to further identify the spectrum of responsive tumors, to identify the molecular mechanisms associated with retinoid action, and to identify and develop new retinoids that have unique properties and an improved therapeutic index.
Other Name: Targretin
  • Experimental: Bexarotene
    Bexarotene / Targretin
    Intervention: Drug: bexarotene
  • Placebo Comparator: Sugar Pill
    Sugar pill / placebo
    Intervention: Drug: bexarotene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
September 2006
September 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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 irradiated
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 30%

Hepatic

  • 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

Renal

  • Creatinine no greater than 1.5 times ULN

Other

  • 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)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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 modulators
  • No concurrent hormone replacement therapy
  • Concurrent thyroid hormone supplementation allowed

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055991
CDR0000271913, 5U19CA086809
Yes
Baylor Breast Care Center
Baylor Breast Care Center
National Cancer Institute (NCI)
Study Chair: Richard M. Elledge, MD Baylor College of Medicine
Baylor Breast Care Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP