Recruiting

Observational Study

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT04297020

Conditions

Cognitive Impairment

Cognitive Function

Eligibility Criteria

Sex: Female

Age: 35 - 65

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Cognitive Impairment

Cognitive Function

Study ID

NCT04297020

Start date

Mar 11, 2020

Status verified date

Jul, 2026

Completion date

Mar 15, 2028

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Pre-menopausal BCS + ET

Pre-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)

Post-menopausal BCS + ET

Post-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)

Pre-menopausal Healthy Control

Pre-menopausal healthy control group

Post-menopausal Healthy Control

Post-menopausal healthy control group

Primary outcome measure

  • Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. [ Time Frame: Day 1 ]
  • Cognitive function comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Kathleen Van Dyk, PhD

310 825-2719KVanDyk@mednet.ucla.edu

Locations

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Kathleen Van Dyk

310-825-2719kvandyk@mednet.ucla.edu

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Breast cancer
  • endocrine therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-07-07.