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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00681928 |
RATIONALE: Gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment.
PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy volunteers.
Condition | Intervention |
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Breast Cancer |
Drug: anastrozole Drug: letrozole Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: questionnaire administration |
Study Type: | Observational |
Official Title: | The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity.
Patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., Squire Memory Self-Rating Questionnaire, and FACT-B Quality of Life Measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. Patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Patient diagnosed with breast cancer
Age-matched healthy volunteer (control)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Principal Investigator: | Arti Hurria, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000589001, CHNMC-07006 |
Study First Received: | May 20, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00681928 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Anastrozole Skin Diseases Breast Neoplasms Letrozole Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |