Actively Recruiting
Older Breast Cancer Patients: Risk for Cognitive Decline
Led by Georgetown University · Updated on 2025-03-11
1700
Participants Needed
1
Research Sites
769 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
M
Memorial Sloan Kettering Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Older Breast Cancer Patients: Risk for Cognitive Decline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Age 60 years or older at diagnosis of new primary breast adenocarcinoma
- AJCC stage 0 to 3 breast cancer or planning neoadjuvant therapy
- Able to communicate well in English verbally and in writing to complete assessments and give consent
- Stable dose of psychoactive medications for at least two months prior to enrollment if applicable
- No previous or current chemotherapy or hormonal treatment use for cancer (excluding hormonal replacement or synthetic thyroid hormones)
- For controls: female, age 60 years or older, able to communicate well in English, and stable psychoactive medication dose if applicable
You will not qualify if you...
- History of diagnosed neurological problems (Alzheimer's, Parkinson's, Multiple Sclerosis, Dementia, Seizure Disorders, brain tumors)
- History of brain surgery for any reason
- History of stroke, except TIA more than one year ago
- HIV/AIDS diagnosis
- Moderate to severe head trauma with loss of consciousness over 60 minutes or brain changes on imaging
- History of major psychiatric disorders or substance abuse
- History of prior breast or other cancer except non-melanoma skin cancer; for cases, prior cancer treatment completed at least 5 years ago without chemotherapy or hormonal therapy
- Previous or current chemotherapy or hormonal therapy use
- Use of methotrexate, rituximab, or cyclophosphamide for autoimmune diseases
- Visual or hearing impairments that prevent completion of interviews or neuropsychological testing
- Non-English speaking
- For neuroimaging: claustrophobia, MRI-incompatible implants or devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
Research Team
J
Jeanne Mandelblatt
CONTACT
M
Meghan Mihalache
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here