NCT02290834

Brief Summary

This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress87%
Mar 2015Jan 2028

First Submitted

Initial submission to the registry

November 5, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

12.8 years

First QC Date

November 5, 2014

Last Update Submit

March 9, 2026

Conditions

Impaired CognitionChemo-brainBreast Cancer

Keywords

Chemotherapy related cognitive impairmentChemo-brain

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive performance scores

    Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

Secondary Outcomes (3)

  • Correlation between baseline amyloid accumulation in the brain and change in cognitive performance

    Baseline, 6 months after completion of chemotherapy

  • Correlation between baseline tau accumulation in the brain and change in cognitive performance

    Baseline, 6 months after completion of chemotherapy

  • Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy)

    Baseline, 6 months after completion of chemotherapy

Study Arms (3)

ARM 1

ACTIVE COMPARATOR

Breast cancer patients treated with chemotherapy * Cognitive, functional and subjective assessments (Pre and Post Treatment) * Imaging (Pre and Post Treatment) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Other: Cognitive, functional and subjective assessmentsDevice: MRIRadiation: PET Scan

ARM 2

ACTIVE COMPARATOR

Non-treated breast cancer patient control * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Other: Cognitive, functional and subjective assessmentsDevice: MRIRadiation: PET Scan

ARM 3

ACTIVE COMPARATOR

Healthy control subjects * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Other: Cognitive, functional and subjective assessmentsDevice: MRIRadiation: PET Scan

Interventions

Cognitive, functional and subjective assessmentsOTHER

Cognitive and functional assessments

ARM 1ARM 2ARM 3
MRIDEVICE

Magnetic Resonance Imaging (MRI) Scan

ARM 1ARM 2ARM 3
PET ScanRADIATION

Positron Emission Tomography (PET) Scan

ARM 1ARM 2ARM 3

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer patients treated with chemotherapy- Group 1 (experimental group)
  • Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study
  • New diagnosis histologically confirmed invasive breast cancer
  • Treatment plan to include chemotherapy
  • Female subjects age ≥ 60 years.
  • Life expectancy ≥ 1 year
  • Karnofsky Performance Score (KPS) ≥ 80
  • Ability to understand and the willingness to sign a written informed consent document.
  • Non-treated breast cancer patient controls- Group 2 (control group)
  • Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
  • New diagnosis histologically confirmed invasive breast cancer
  • Treatment plan does not include chemotherapy
  • Age ≥ 60 years.
  • Life expectancy ≥ 1 year
  • Karnofsky Performance Score (KPS) ≥ 80
  • +9 more criteria

You may not qualify if:

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
  • Participants with clinical or radiographic evidence of metastatic CNS disease
  • Subjects with MMSE scores below 24
  • Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed).
  • Substance abuse within the past 2 years
  • Huntington's disease, hydrocephalus or seizure disorder
  • Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Massachusetts General Hospital/North Shore Cancer Center

Salem, Massachusetts, 01970, United States

RECRUITING

MeSH Terms

Conditions

Cognition DisordersBreast NeoplasmsChemotherapy-Related Cognitive Impairment

Interventions

Functional StatusMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersCognitive Dysfunction

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Michael Parsons, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael W Parsons, PhD

CONTACT

617-643-0282mwparsons@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 14, 2014

Study Start

March 1, 2015

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

US(2)