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Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. 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 committed 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. health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts 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 permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes 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. Participants oftentimes recieve the most expert healthcare available for their Efficacy and safety study of letrozole plus ZARNESTRA or placebo in the treatment of advanced breast cancer. condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous 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
Other Breast Cancer Studies:
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2. Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
3. Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
4. BMS-247550 in Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer
5. Combination Chemotherapy (FLAC) Combined with Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast 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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