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The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer


N/A
65 Years
N/A
Not Enrolling
Female
Breast Cancer

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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 CenterDuarte, California  91010