NCT03451383: TLC

Older Breast Cancer Patients: Risk for Cognitive Decline

Recruiting now Last updated 11 March 2025

What this trial tests

trial in Cancer, Breast in 1,700 participants. Currently enrolling.

Timeline

1 August 2010

Primary endpoint
30 April 2025

30 April 2025

Quick facts

Lead sponsor	Georgetown University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,700
Start date	1 August 2010
Primary completion	30 April 2025
Estimated completion	30 April 2025
Sites	1 location across United States

Conditions studied

• Cancer, Breast — all drugs for Cancer, Breast →
• Age-related Cognitive Decline — all drugs for Age-related Cognitive Decline →
• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

Georgetown University

Who can join

Adults 60 to 105, female only, with Cancer, Breast or Age-related Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer-Related Cognitive Outcomes Among Older Breast Cancer Survivors in the Thinking and Living With Cancer Study.
   Mandelblatt JS, Small BJ, Luta G, Hurria A, et al · · 2018 · cited 130× · PMID 30281396 · DOI 10.1200/jco.18.00140
2. Symptom burden among older breast cancer survivors: The Thinking and Living With Cancer (TLC) study.
   Mandelblatt JS, Zhai W, Ahn J, Small BJ, et al · · 2020 · cited 64× · PMID 31860135 · DOI 10.1002/cncr.32663
3. Loneliness and mental health during the COVID-19 pandemic in older breast cancer survivors and noncancer controls.
   Rentscher KE, Zhou X, Small BJ, Cohen HJ, et al · · 2021 · cited 62× · PMID 34161601 · DOI 10.1002/cncr.33687
4. Targeting miRNAs and Other Non-Coding RNAs as a Therapeutic Approach: An Update.
   Bayraktar E, Bayraktar R, Oztatlici H, Lopez-Berestein G, et al · · 2023 · cited 51× · PMID 37104009 · DOI 10.3390/ncrna9020027
5. Deficit Accumulation Frailty Trajectories of Older Breast Cancer Survivors and Non-Cancer Controls: The Thinking and Living With Cancer Study.
   Mandelblatt JS, Zhou X, Small BJ, Ahn J, et al · · 2021 · cited 47× · PMID 33484565 · DOI 10.1093/jnci/djab003
6. Pretreatment Psychoneurological Symptoms and Their Association With Longitudinal Cognitive Function and Quality of Life in Older Breast Cancer Survivors.
   Tometich DB, Small BJ, Carroll JE, Zhai W, et al · · 2019 · cited 39× · PMID 30472317 · DOI 10.1016/j.jpainsymman.2018.11.015
7. Elevated C-Reactive Protein and Subsequent Patient-Reported Cognitive Problems in Older Breast Cancer Survivors: The Thinking and Living With Cancer Study.
   Carroll JE, Nakamura ZM, Small BJ, Zhou X, et al · · 2023 · cited 30× · PMID 36179271 · DOI 10.1200/jco.22.00406
8. Multimodal MRI examination of structural and functional brain changes in older women with breast cancer in the first year of antiestrogen hormonal therapy.
   McDonald BC, Van Dyk K, Deardorff RL, Bailey JN, et al · · 2022 · cited 18× · PMID 35476252 · DOI 10.1007/s10549-022-06597-1