Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Explore the impact of treatment with an aromatase inhibitor on the cognitive function of postmenopausal women with stage I-III breast cancer vs in cancer-free, age-matched healthy volunteers. 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.

Official Title
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The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: anastrozole
* Drug: letrozole
* Other: questionnaire administration
* Procedure: cognitive assessment
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Patient diagnosed with breast cancer Stage I-III disease Estrogen receptor- and/or progesterone receptor-positive Planning to start treatment with anastrozole or letrozole Age-matched healthy volunteer (control) No history of breast cancer Not receiving adjuvant aromatase inhibitor therapy PATIENT CHARACTERISTICS: Postmenopausal Able to converse, write, and read English No claustrophobia (patients participating in the PET scan correlative study) PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior hormonal therapy, including estrogen replacement therapy No previous treatment with CNS radiation

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer patients receiving aromatase treatment<br> | Drug: anastrozole<br>* As determined by the subject's physician<br>Drug: letrozole<br>* As determined by the subject's physician<br>Other: questionnaire administration<br>* For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.<br>Procedure: cognitive assessment<br>* For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.<br>Procedure: psychosocial assessment and care<br>* For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.<br>|
| Healthy female controls age 60 and older<br> | Other: questionnaire administration<br>* For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.<br>Procedure: cognitive assessment<br>* For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.<br>Procedure: psychosocial assessment and care<br>* For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of treatment with an aromatase inhibitor on cognitive function |  | Prior to starting aromatase treatment and 6 months after starting the medication. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer