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A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer (NCT00003752)

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.
  • Drug: bexarotene
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    30 locations

    United States (30)
    • University of Alabama Comprehensive Cancer Center
      Birmingham, Alabama, United States, 35294
    • Arizona Cancer Center
      Tucson, Arizona, United States, 85724
    • University of Arkansas for Medical Sciences
      Little Rock, Arkansas, United States, 72205
    • USC/Norris Comprehensive Cancer Center
      Los Angeles, California, United States, 90033-0800
    • Jonsson Comprehensive Cancer Center, UCLA
      Los Angeles, California, United States, 90095-1781
    • Beckman Research Institute, City of Hope
      Los Angeles, California, United States, 91010
    • Kaiser Permanente-Southern California Permanente Medical Group
      San Diego, California, United States, 92120
    • UCSF Cancer Center and Cancer Research Institute
      San Francisco, California, United States, 94115-0128
    • Yale Comprehensive Cancer Center
      New Haven, Connecticut, United States, 06520-8028
    • Vincent T. Lombardi Cancer Research Center, Georgetown University
      Washington, District of Columbia, United States, 20007
    • Baptist Regional Cancer Institute - Jacksonville
      Jacksonville, Florida, United States, 32207
    • Mayo Clinic Jacksonville
      Jacksonville, Florida, United States, 32224
    • Sylvester Cancer Center, University of Miami
      Miami, Florida, United States, 33136
    • Cancer Research Center of Hawaii
      Honolulu, Hawaii, United States, 96813
    • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      Chicago, Illinois, United States, 60611
    • Louisiana State University School of Medicine
      New Orleans, Louisiana, United States, 70112-2822
    • Dana-Farber Cancer Institute
      Boston, Massachusetts, United States, 02115
    • Beth Israel Deaconess Medical Center
      Boston, Massachusetts, United States, 02215
    • Michigan State University
      East Lansing, Michigan, United States, 48824
    • University of Minnesota
      Minneapolis, Minnesota, United States, 55455
    • University of Nebraska Medical Center
      Omaha, Nebraska, United States, 68198-3330
    • Memorial Sloan-Kettering Cancer Center
      New York, New York, United States, 10021
    • Arthur G. James Cancer Hospital - Ohio State University
      Columbus, Ohio, United States, 43210
    • Hematology Oncology Consultants Inc
      Columbus, Ohio, United States, 43235
    • Oregon Cancer Center at Oregon Health Sciences University
      Portland, Oregon, United States, 97201-3098
    • University of Pennsylvania Cancer Center
      Philadelphia, Pennsylvania, United States, 19104
    • Sarah Cannon-Minnie Pearl Cancer Center
      Nashville, Tennessee, United States, 37203
    • University of Texas - MD Anderson Cancer Center
      Houston, Texas, United States, 77030
    • University of Texas Health Science Center at San Antonio
      San Antonio, Texas, United States, 78284-7811
    • Cancer Center, University of Virginia HSC
      Charlottesville, Virginia, United States, 22908
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    30 September, 1998
    Updated:
    28 May, 2013
    Participants:
    180
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