Cognitive ImpairmentNCT04297020
Brain Health in Breast Cancer Survivors
An observational study of Cognitive Impairment and Cognitive Function, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Cognitive Function
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 15 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Age 35-65
- Fluent in English
- Adequate vision/hearing to complete testing
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California at Los Angeles
Los Angeles, California, 90095
Kathleen Van Dyk, 310-825-2719, kvandyk@mednet.ucla.edu
About this study
Official title: Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy
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.
Read the 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.
- Conditions
- Cognitive Impairment, Cognitive Function
- Keywords
- Breast cancer, endocrine therapy
- Medical subject headings
- Cognitive Dysfunction, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start11 Mar 2020
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathleen Van Dyk, PhD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297020
- Sponsor's protocol ID
- 19-001004
- Other IDs
- K08CA241337, NCI-2020-01501
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy
- ClinicalTrials.gov ID
- NCT04297020
- Acronym / sponsor ID
- 19-001004
- Conditions
- Cognitive Impairment, Cognitive Function
- Keywords
- Breast cancer, endocrine therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Age 35-65
- Fluent in English
- Adequate vision/hearing to complete testing
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.
Time frame: Day 1
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.
Cognitive function comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.
Time frame: Day 1
To compare cognitive function between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Van Dyk, PhD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Cognitive Function, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Van Dyk, PhD (310 825-2719, KVanDyk@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.