The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
65 Years
N/A
Female
Breast Cancer
Trial Information
The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Impact of treatment with an aromatase inhibitor on cognitive function
Outcome Time Frame:
Prior to starting aromatase treatment and 6 months after starting the medication.
Safety Issue:
No
Principal Investigator
Arti Hurria, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
07006
NCT ID:
NCT00681928
Start Date:
October 2007
Completion Date:
January 2011
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
