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Brain Health in Breast Cancer Survivors

Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04297020
Enrollment
120
Registered
2020-03-05
Start date
2020-03-11
Completion date
2028-03-15
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Cognitive Impairment

Keywords

Breast cancer, endocrine therapy

Brief summary

Endocrine therapy (ET) is widely used to treat hormone receptor positive breast cancer and prevent recurrence by downregulating estrogen function. However, ETs readily cross the blood brain barrier and interfere with the action of estrogen in the brain. Estrogen supports cognition and menopausal status is closely linked to cognitive health in women. This has raised concern that anti-estrogen ETs may affect cognition and brain health in breast cancer survivors. However, evidence across existing studies is inconsistent and these effects remain poorly understood. The incomplete understanding of the effects of ET are likely due to limitations of earlier studies - namely, the under-appreciation of the role of menopausal status and insensitivity of standard cognitive measures. This research project will address these earlier limitations by specifically comparing ET effects by menopausal status, and using highly sensitive, task-related functional magnetic resonance imaging (fMRI) measures to assess the effects of ET on brain function.

Detailed description

Endocrine therapy (ET) is widely used to treat hormone receptor positive breast cancer and prevent recurrence by downregulating estrogen function. However, ETs readily cross the blood brain barrier and interfere with the action of estrogen in the brain. Estrogen supports cognition and menopausal status is closely linked to cognitive health in women. This has raised concern that anti-estrogen ETs may affect cognition and brain health in breast cancer survivors. However, evidence across existing studies is inconsistent and these effects remain poorly understood. The incomplete understanding of the effects of ET are likely due to limitations of earlier studies - namely, the under-appreciation of the role of menopausal status and insensitivity of standard cognitive measures. This research project will address these earlier limitations by specifically comparing ET effects by menopausal status, and using highly sensitive, task-related fMRI measures to assess the effects of ET on brain function. This study is a cross-sectional study in a 2x2 factorial design comparing menopausal status (pre and post) and patient group (breast cancer survivors on ET and healthy controls matched on age, race, education, and time since final menstrual period (post only)). The investigators will use sensitive fMRI measures of brain activity during a working memory task - measures successfully used to reveal the effects of menopause and estrogen changes in healthy women, but yet to be extensively used to study the effects of ET.

Interventions

None listed

Sponsors

Jonsson Comprehensive Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 35-65 * Fluent in English * Adequate vision/hearing to complete testing

Exclusion criteria

* History of major or mild neurocognitive disorder or dementia * Diagnosis of major neurological condition (e.g., epilepsy, Parkinson's Disease, stroke) * Diagnosis of a major psychiatric disorder (e.g., bipolar disorder, schizophrenia) * Untreated/unstable unipolar depression or anxiety * Prior history of cancer or chemotherapy (for controls, any history) * History of a learning disorder * History of head injury with loss of consciousness \>20 minutes * History of salpingo-oophorectomy or hysterectomy * A cardiac pacemaker * Implanted electronic device * Claustrophobia * Currently pregnant * Orbital metal implant or other metallic foreign bodies Additional

Design outcomes

Primary

MeasureTime frameDescription
Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.Day 1To compare brain activity using fMRI during a working memory task between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.
Cognitive function comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.Day 1To compare cognitive function between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.

Countries

United States

Contacts

CONTACTKathleen Van Dyk, PhD
KVanDyk@mednet.ucla.edu310 825-2719
PRINCIPAL_INVESTIGATORKathleen Van Dyk, PhD

University of California at Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026