Clinical trial NCT00681928: Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
Official title: The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-21
Enrollment: 72
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients and healthy control subjects

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.

Eligibility 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

Primary outcomes:
measure: Impact of treatment with an aromatase inhibitor on cognitive function
timeFrame: Prior to starting aromatase treatment and 6 months after starting the medication.
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Arti Hurria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.