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Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. Clinical research trials and Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer.. Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer.  Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer.
Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer.
For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: The purpose of this study is to determine if the addition of ZARNESTRA to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion criteria: - locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer - ER- and/or PgR-positive disease - progression of disease after antiestrogen therapy - measurable disease - postmenopausal - fully active, ambulatory and able to carry out work of a light or sedentary nature or unable to carry out any work activities. Up and about more than 50% of waking hours. - hematologic and blood biochemistry and values within limits - ability to understand and provide signed informed consent Exclusion criteria: - previous systemic endocrine therapy, other than antiestrogen therapy - more than 1 prior chemotherapy regimen - previous therapy with farnesyl transferase inhibitor - less than 30 days since participation in another investigational drug study - presence of rapidly progressive, life-threatening metastases - concomitant anticancer treatment - other malignancy within the past 5 years - symptomatic peripheral neuropathy - allergy to letrozole or imidazole drugs - any coexisting medical condition that is likely to interfere with study procedures and/or results
Total Enrollment:
Location and Contact Information:
Texas Oncology, P.A.
Ft. Worth, Texas, 76104
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
University Hospitals of Cleveland; Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Rush-Presbyterian St. Luke’s Medical Center
Chicago, Illinois, 60612-3863
United States
Norton Healthcare
Louisville, Kentucky, 40202
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Miami / Braman Breast Cancer Institute
Miami, Florida, 33136
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Washington University
St. Louis, Missouri, 63110
United States
Texas Oncology, P.A.
Dallas, Texas, 75246
United States
Presbyterian Healthcare System
Charlotte, North Carolina, 28233
United States
Additional Information:
Study ID Numbers: R115777-INT-22;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050141
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2. Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer
3. Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
4. Risedronate Sodium on Bone in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer
5. Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer
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Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer.
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