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OpenTrials
Completed

NCT Number: NCT00681928

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

As determined by the subject's physician

letrozole

Drug

As determined by the subject's physician

Questionnaire Administration

Other

For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.

cognitive assessment

Procedure

For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.

psychosocial assessment and care

Procedure

For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.

Primary outcomes

  1. Impact of treatment with an aromatase inhibitor on cognitive function

    Time frame: Prior to starting aromatase treatment and 6 months after starting the medication.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 21, 2008
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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