Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

NCT00055991 | Completed Phase 1 DMC

• 2 other identifiers: CDR00002719135U19CA086809
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Apoptosis at day 29 during study treatment

Study Arms (2)

Bexarotene

EXPERIMENTAL

Bexarotene / Targretin

Drug: bexarotene

Sugar Pill

PLACEBO COMPARATOR

Sugar pill / placebo

Drug: bexarotene

Interventions

bexarotene DRUG

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.

Also known as: Targretin

Bexarotene; Sugar Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Richard M. Elledge, MD

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: September 1, 2001
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (4)