Clinical trial · Observational
Brain Health in Breast Cancer Survivors
Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy
- 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Function | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Pre-menopausal BCS + ET
- description
- Pre-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)
- label
- Post-menopausal BCS + ET
- description
- Post-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)
- label
- Pre-menopausal Healthy Control
- description
- Pre-menopausal healthy control group
- label
- Post-menopausal Healthy Control
- description
- Post-menopausal healthy control group
Primary outcomes (2)
- measure
- Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 exclusion criteria for controls: current use of a contraceptive agent that interferes with endogenous hormonal fluctuation (e.g., oral contraceptive pill) or precludes determination of menstrual pattern (e.g., hormonally secreting intrauterine device), or current treatment with systemic estrogen replacement therapy.
References
Publications (0)
Data not yet available