NCT00681928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

3.3 years

First QC Date

May 20, 2008

Last Update Submit

November 30, 2011

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Impact of treatment with an aromatase inhibitor on cognitive function

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

Study Arms (2)

Breast Cancer patients receiving aromatase treatment

Drug: anastrozoleDrug: letrozoleOther: questionnaire administrationProcedure: cognitive assessmentProcedure: psychosocial assessment and care

Healthy female controls age 60 and older

Other: questionnaire administrationProcedure: cognitive assessmentProcedure: psychosocial assessment and care

Interventions

anastrozoleDRUG

As determined by the subject's physician

Breast Cancer patients receiving aromatase treatment
letrozoleDRUG

As determined by the subject's physician

Breast Cancer patients receiving aromatase treatment
questionnaire administrationOTHER

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

Breast Cancer patients receiving aromatase treatmentHealthy female controls age 60 and older
cognitive assessmentPROCEDURE

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

Breast Cancer patients receiving aromatase treatmentHealthy female controls age 60 and older
psychosocial assessment and carePROCEDURE

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

Breast Cancer patients receiving aromatase treatmentHealthy female controls age 60 and older

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients and healthy control subjects

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Related Publications (1)

  • 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.

    PMID: 24291380DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnastrozoleLetrozoleMental Status and Dementia TestsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNeuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Arti Hurria, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 21, 2008

Study Start

October 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 2, 2011

Record last verified: 2011-11

Locations

US(1)