Bexarotene in Treating Patients With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003752
- Lead Sponsor
- Ligand Pharmaceuticals
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to study the effectiveness of bexarotene in treating patients who have metastatic breast cancer.
- Detailed Description
OBJECTIVES: I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose levels in patients with advanced breast cancer. II. Assess the safety and tolerability of this treatment regimen in this patient population. III. Evaluate the efficacy of oral bexarotene in terms of induction of differentiation and decreased aberrant cell proliferation in these patients.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to prior therapy for metastatic disease. Patients are randomized to one of two dose levels. All patients receive oral bexarotene once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every week for the first month, at weeks 6 and 8, then monthly thereafter.
PROJECTED ACCRUAL: A total of 84-180 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Scroll for more (20 remaining)University of Alabama Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States