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Brain Health in Breast Cancer Survivors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 65 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how hormone-blocking breast cancer treatment may affect thinking and brain health in breast cancer survivors. It uses brain scans during tasks to compare effects based on whether menopause has occurred. It includes people ages 35–65, including a comparison group with no cancer history.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 35–65.
  • Fluent in English.
  • Able to see and hear well enough to complete testing.

Who can't join

  • History of a thinking or memory disorder, dementia, a learning disorder, or a major brain or nerve condition, such as epilepsy, Parkinson’s disease, or stroke.
  • A major mental health disorder, such as bipolar disorder or schizophrenia, or depression or anxiety that is untreated or not stable.
  • Past cancer or chemotherapy; comparison group members cannot have any cancer or chemotherapy history.
  • Past head injury that caused you to pass out for more than 20 minutes.
  • Past surgery to remove the ovaries and fallopian tubes, or the uterus.
  • A pacemaker, an implanted electronic device, metal in the eye socket, or other metal objects in the body.
  • Fear of tight or closed spaces, or currently pregnant.
  • For comparison group members: current birth control that changes natural hormone levels or makes periods hard to track, or estrogen replacement treatment that acts throughout the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

CA