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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-07006 | |||
| CDR0000589001 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer patients receiving aromatase treatment |
| ||
| Healthy female controls age 60 and older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anastrozole | Drug | As determined by the subject's physician |
|
| 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. |
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Patient diagnosed with breast cancer
Age-matched healthy volunteer (control)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Breast cancer patients and healthy control subjects
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| Name | Affiliation | Role |
|---|---|---|
| Arti Hurria, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24291380 | Derived | Hurria A, Patel SK, Mortimer J, Luu T, Somlo G, Katheria V, Ramani R, Hansen K, Feng T, Chuang C, Geist CL, Silverman DH. The effect of aromatase inhibition on the cognitive function of older patients with breast cancer. Clin Breast Cancer. 2014 Apr;14(2):132-40. doi: 10.1016/j.clbc.2013.10.010. Epub 2013 Oct 25. |
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| letrozole | Drug | As determined by the subject's physician |
|
| questionnaire administration | Other | For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration. |
|
| cognitive assessment | Procedure | For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration. |
|
| psychosocial assessment and care | Procedure | For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| D000073216 | Mental Status and Dementia Tests |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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