NCT04297020

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Mar 2020Mar 2028

First Submitted

Initial submission to the registry

February 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2025

Enrollment Period

7 years

First QC Date

February 28, 2020

Last Update Submit

May 7, 2026

Conditions

Cognitive ImpairmentCognitive Function

Keywords

Breast cancerendocrine therapy

Outcome Measures

Primary Outcomes (2)

  • Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.

    To 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.

    Day 1

  • Cognitive function comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.

    To compare cognitive function between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.

    Day 1

Study Arms (4)

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

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPre-menopausal and post-menopausal breast cancer survivors who are undergoing endocrine therapy.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pre-menopausal and post-menopausal breast cancer survivors who are undergoing endocrine therapy will be compared to healthy control group matched by age, race, education and time since final menstrual period (post only).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionBreast Neoplasms

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kathleen Van Dyk, PhD

    University of California at Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Van Dyk, PhD

CONTACT

310 825-2719KVanDyk@mednet.ucla.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 5, 2020

Study Start

March 11, 2020

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2028

Last Updated

May 11, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)