Bexarotene in Preventing Breast Cancer in Women at Genetic Risk - Full Text View

Sponsor:	Baylor College of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055991

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: bexarotene

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Bexarotene

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Apoptosis at day 29 during study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2001

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055991

Locations

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

Baylor College of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Richard M. Elledge, MD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000271913, BCM-H-9315
Study First Received:	March 6, 2003
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00055991 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Additional relevant MeSH terms:

Anticarcinogenic Agents
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Bexarotene

Therapeutic Uses
Physiological Effects of Drugs
Breast Neoplasms
Protective Agents
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009