Status
Recruiting
Phase
N/A
Study type
Observational
Enrollment
120
Sex
Women only
Ages
Ages 35 Years to 65 Years
Primary completion
2026-03-15
Last update
2025-05-13

What this trial studies

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.

Conditions in scope

  • Cognitive Impairment
  • Cognitive Function

Interventions

  • Not specified in the public record.

Who can join

Women only · Ages 35 Years to 65 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Los Angeles California University of California at Los Angeles Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Observational
  • Phase: N/A
  • Start date: 2020-03-11
  • Primary completion: 2026-03-15
  • Last update posted: 2025-05-13
  • First posted: 2020-03-05

Lead sponsor: Jonsson Comprehensive Cancer Center (Other)

Collaborators: National Cancer Institute (NCI)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. (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. (Day 1)
    To compare cognitive function between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT04297020 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.