Breast CancerNCT00681928
Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole, letrozole and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2007to 1 Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, letrozole, questionnaire administration, cognitive assessment, psychosocial assessment and care
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
As determined by the subject's physician
letrozoleDrug
As determined by the subject's physician
questionnaire administrationOther
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
cognitive assessmentProcedure or surgery
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
psychosocial assessment and careProcedure or surgery
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer patients receiving aromatase treatment | Not described Receives: Drug: anastrozole; Drug: letrozole; Other: questionnaire administration; Procedure: cognitive assessment; Procedure: psychosocial assessment and care | |
| Healthy female controls age 60 and older | Not described Receives: Other: questionnaire administration; Procedure: cognitive assessment; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of treatment with an aromatase inhibitor on cognitive function
Measured: Prior to starting aromatase treatment and 6 months after starting the medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study start5 Dec 2007
- Primary completion1 Jan 2011
- Study completion1 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arti Hurria, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681928
- Sponsor's protocol ID
- 07006
- Other IDs
- P30CA033572, CHNMC-07006, CDR0000589001
- Status last verified
- Oct 2026
- First submitted
- 20 May 2008
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24291380
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00681928
- Acronym / sponsor ID
- 07006
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Dec 2007 (actual)
- Primary completion
- 1 Jan 2011 (actual)
- Study completion
- 1 Jan 2011 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer patients receiving aromatase treatment | – | Drug: anastrozole, Drug: letrozole, Other: questionnaire administration, Procedure: cognitive assessment, Procedure: psychosocial assessment and care |
| Healthy female controls age 60 and older | – | Other: questionnaire administration, Procedure: cognitive assessment, Procedure: psychosocial assessment and care |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Breast cancer patients and healthy control subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anastrozoleAs determined by the subject's physician | Drug | Breast Cancer patients receiving aromatase treatment |
| letrozoleAs determined by the subject's physician | Drug | Breast Cancer patients receiving aromatase treatment |
| questionnaire administrationFor cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration. | Other | Breast Cancer patients receiving aromatase treatment, Healthy female controls age 60 and older |
| cognitive assessmentFor cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration. | Procedure or surgery | Breast Cancer patients receiving aromatase treatment, Healthy female controls age 60 and older |
| psychosocial assessment and careFor cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration. | Procedure or surgery | Breast Cancer patients receiving aromatase treatment, Healthy female controls age 60 and older |
Primary outcome
Impact of treatment with an aromatase inhibitor on cognitive function
Time frame: Prior to starting aromatase treatment and 6 months after starting the medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 24291380Hurria 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arti Hurria, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of treatment with an aromatase inhibitor on cognitive function (time frame: Prior to starting aromatase treatment and 6 months after starting the medication.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.