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

City of Hope

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: cognitive assessment; Drug: letrozole; Drug: anastrozole; Procedure: psychosocial assessment and care; Other: questionnaire administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00681928

07006

CHNMC-07006

CDR0000589001 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

72 participants in 2 patient groups

Breast Cancer patients receiving aromatase treatment

Treatment:

Procedure: psychosocial assessment and care

Procedure: cognitive assessment

Other: questionnaire administration

Drug: letrozole

Drug: anastrozole

Healthy female controls age 60 and older

Treatment:

Procedure: psychosocial assessment and care

Procedure: cognitive assessment

Other: questionnaire administration