Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 6, 2003

Last Updated Date

February 4, 2013

Start Date ^ICMJE

September 2001

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00055991 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Bexarotene
Bexarotene / Targretin

Intervention: Drug: bexarotene
Placebo Comparator: Sugar Pill
Sugar pill / placebo

Intervention: Drug: bexarotene

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00055991

Other Study ID Numbers ^ICMJE

CDR0000271913, 5U19CA086809

Has Data Monitoring Committee

Yes

Responsible Party

Baylor Breast Care Center

Study Sponsor ^ICMJE

Baylor Breast Care Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Richard M. Elledge, MD

Baylor College of Medicine

Information Provided By

Baylor Breast Care Center

Verification Date

February 2013

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

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