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Phase III Randomized Study of Adjuvant Endocrine Therapy Comprising Letrozole, Anastrazole, or Exemestane Versus Tamoxifen Citrate in Postmenopausal Women With Breast Cancer
Alternate Title Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics:
Expected Enrollment 60Outcomes Primary Outcome(s)Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test Changes in other cognitive functions at 6 and 12 months of treatment Outline This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients undergo cognitive, psychological, social, and quality of life assessments every 6 months using the CDS scale, the Edinburgh Handedness Inventory, the Mini Mental Test, the French version of the National Adult Reading Test, the Benton Visual Retention test, the direct and indirect capacities of the WAIS-R, the WMS sequential visual-spatial capacity, the dual task test, categorical and formal verbal fluency, the Trail making test, the Stroop test, the Wisconsin Card Sorting test, the choice reaction time test, the sequential visual spatial capacity, the HADS scale, IADL, and QLQ-C30 questionnaires. After completion of study treatment, patients are followed for 1 year. Trial Lead Organizations Institut National du Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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