NCT01992432

Brief Summary

This study will use advanced MRI techniques to characterize the changes that occur to the structure and functionality of the brain in older breast cancer patients receiving adjuvant chemotherapy, and determine the relationship between the brain changes and severity of chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging markers of aging, breast cancer and chemotherapy treatment, and will contribute to our understanding of the underlying pathophysiology of cognitive changes and chemotherapy toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the foundation for future, larger scale clinical studies of cognitive changes and chemotherapy toxicity in the aging cancer population.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2013Nov 2026

Study Start

First participant enrolled

September 30, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

13.2 years

First QC Date

November 14, 2013

Last Update Submit

January 27, 2026

Conditions

Breast Cancer

Keywords

Brain magnetic resonance imagingchemotherapy toxicityolder womanbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Intensity of brain activation during functional brain MRI.

    Prior to and after chemotherapy in older patients with breast cancer.

    2 years

Secondary Outcomes (3)

  • NIH Tool box cognitive assessment.

    2 years

  • Structural MRI brain parameters.

    2 years

  • Chemotherapy toxicity.

    2 years

Study Arms (1)

Single-group study: chemotherapy

Single-group study: chemotherapy

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Using a prospective longitudinal study design, 25 patients will be recruited for this study from the outpatient medical oncology practice at City of Hope Medical Center.

You may qualify if:

  • \) Patients with stage I-III breast cancers who are to receive adjuvant chemotherapy;
  • \) Able to understand English (the functional MRI task paradigms and neurocognitive testing are not validated in languages other than English);
  • \) Able to provide informed consent;
  • \) Patients age ≥ 65 and of any performance status.

You may not qualify if:

  • \) Patients with metastatic disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

Related Publications (4)

  • Chen BT, Ghassaban K, Jin T, Patel SK, Ye N, Sun CL, Kim H, Rockne RC, Mark Haacke E, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Waisman J, Yuan Y, Somlo G, Li D, Yang R, Tan H, Katheria V, Morrison R, Hurria A. Subcortical brain iron deposition and cognitive performance in older women with breast cancer receiving adjuvant chemotherapy: A pilot MRI study. Magn Reson Imaging. 2018 Dec;54:218-224. doi: 10.1016/j.mri.2018.07.016. Epub 2018 Aug 2.

    PMID: 30076946BACKGROUND

  • Chen BT, Ye N, Wong CW, Patel SK, Jin T, Sun CL, Rockne RC, Kim H, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Sedrak MS, Waisman J, Yuan Y, Li D, Vazquez J, Katheria V, Dale W. Effects of chemotherapy on aging white matter microstructure: A longitudinal diffusion tensor imaging study. J Geriatr Oncol. 2020 Mar;11(2):290-296. doi: 10.1016/j.jgo.2019.09.016. Epub 2019 Nov 2.

    PMID: 31685415DERIVED

  • Chen BT, Jin T, Patel SK, Ye N, Sun CL, Ma H, Rockne RC, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Waisman J, Yuan Y, Li D, Somlo G, Vazquez J, Levi A, Tan H, Yang R, Katheria V, Hurria A. Gray matter density reduction associated with adjuvant chemotherapy in older women with breast cancer. Breast Cancer Res Treat. 2018 Nov;172(2):363-370. doi: 10.1007/s10549-018-4911-y. Epub 2018 Aug 7.

    PMID: 30088178DERIVED

  • Chen BT, Sethi SK, Jin T, Patel SK, Ye N, Sun CL, Rockne RC, Haacke EM, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Waisman J, Yuan Y, Somlo G, Li D, Yang R, Tan H, Katheria V, Morrison R, Hurria A. Assessing brain volume changes in older women with breast cancer receiving adjuvant chemotherapy: a brain magnetic resonance imaging pilot study. Breast Cancer Res. 2018 May 2;20(1):38. doi: 10.1186/s13058-018-0965-3.

    PMID: 29720224DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bihong T. Chen, MD., Ph.D

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 25, 2013

Study Start

September 30, 2013

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(2)