Clinical trial · Observational
Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
NCT00681928CI-TRIAL-00005861completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| cognitive assessment | Procedure | — | UNRESOLVED |
| letrozole | Drug | Letrozole | ALIAS |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer patients receiving aromatase treatment
- interventionNames
- Drug: anastrozole
- Drug: letrozole
- Other: questionnaire administration
- Procedure: cognitive assessment
- Procedure: psychosocial assessment and care
- label
- Healthy female controls age 60 and older
- interventionNames
- Other: questionnaire administration
- Procedure: cognitive assessment
- Procedure: psychosocial assessment and care
Primary outcomes (1)
- measure
- Impact of treatment with an aromatase inhibitor on cognitive function
- timeFrame
- Prior to starting aromatase treatment and 6 months after starting the medication.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
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 radiationReferences
Publications (1)
- DERIVEDHurria 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 24291380