Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Brief summary
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
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.
Interventions
DRUGanastrozole
As determined by the subject's physician
DRUGletrozole
As determined by the subject's physician
OTHERquestionnaire administration
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
PROCEDUREcognitive assessment
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
PROCEDUREpsychosocial assessment and care
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impact of treatment with an aromatase inhibitor on cognitive function | Prior to starting aromatase treatment and 6 months after starting the medication. |
Countries
United States
Outcome results
None listed