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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), December 2008

First Received: May 20, 2008 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00681928

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: anastrozole Drug: letrozole Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole Anastrozole

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Impact of treatment with an aromatase inhibitor on cognitive function [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681928

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Arti Hurria, MD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000589001, CHNMC-07006
Study First Received:	May 20, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00681928 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Breast Neoplasms

Letrozole
Aromatase Inhibitors
Hormones
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Skin Diseases
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009