Recruiting

Cognition & Systemic Therapy

Sponsor:

Georgetown University

Code:

NCT03451383

Conditions

Cancer, Breast

Age-related Cognitive Decline

Cognitive Decline

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory biomarkers, sleep and physical measures moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Washington Hospital Center, Reston Breast Care Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles.

Conditions

Cancer, Breast

Age-related Cognitive Decline

Cognitive Decline

Study ID

NCT03451383

Start date

Aug 1, 2010

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

For cancer patients, eligibility includes:

  • being female
  • Age 60+ at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
  • AJCC stages 0-3 or planning neoadjuvant therapy
  • In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
  • If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.
  • Participant report of no previous or current chemotherapy or hormonal treatment use (anastrazole, exemestane, etc.) This does not include hormonal replacement therapy, synthetic thyroid hormones, etc.

For controls, eligibility includes:

  • being female
  • Age 60+
  • In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
  • If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.

Exclusion:

We apply the same exclusion criteria for patients and controls.

  • Participant report of a history of formal diagnosis of neurological problems (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, brain tumors, etc.)
  • Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, AV malformations, increased intracranial pressure, etc.)
  • Participant report of a history of stroke (with the exception of TIA if ≥1 year ago)
  • Participant report of HIV/AIDS
  • Participant report of moderate to severe head trauma (loss of consciousness > 60 min or with evidence of structural brain changes on imaging)
  • History of major psychiatric disorder (DSM-IV Axis 1) (i.e. major depressive disorder (untreated or poorly treated), bipolar disorders, schizophrenia, or substance abuse disorders (self-reported and/or stated in medical record).
  • Participant report of a history of prior breast or other cancer with the exception of non-melanoma skin cancer. An exception for cases only: women who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy or hormonal therapy. This previous cancer cannot be breast cancer.
  • Participant report of previous or current chemotherapy or hormonal therapy use
  • Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
  • Visual or hearing impairment that would preclude ability to complete interviews or neuropsychological testing, such as significant macular degeneration or being unable to correct hearing with hearing aides
  • Non-English speaking
  • To participate in the optional neuroimaging portion of the study:

Participant cannot be claustrophobic Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe Participant cannot have any type of implanted electrical device

Study Design

Enrollment

1700 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast Cancer Case

Women age 60+ with a newly diagnosed breast adenocarcinoma staged 0-3.

Non-Cancer Controls

Women age 60+ with no diagnosis of breast cancer.

Primary outcome measure

  • Change in Attention, Processing Speed, Executive Function (APE) Domain [ Time Frame: Baseline and annually up to 5 years ]
  • Change in Learning and Memory (LM) Domain [ Time Frame: Baseline and annually up to 5 years ]
  • Change in Cognition Domain [ Time Frame: Baseline and annually up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

More Information

Sponsor

Georgetown University

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • breast cancer
  • cognitive decline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.