Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Baylor College of Medicine National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055991 |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | September 2001 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Known carrier of a BRCA-1 or BRCA-2 mutation
At risk for carrying a BRCA-1 or BRCA-2 mutation
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Richard M. Elledge, MD | Baylor College of Medicine |
Study ID Numbers: | CDR0000271913, BCM-H-9315 |
Study First Received: | March 6, 2003 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00055991 |
Health Authority: | United States: Federal Government |
breast cancer |
Skin Diseases Bexarotene Disease Progression Breast Neoplasms Breast Diseases |
Anticarcinogenic Agents Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Protective Agents Pharmacologic Actions |