Study of Screening Brain MRIs in Stage IV Breast Cancer

January 29, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute

Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Clearwater, Florida, United States, 33756
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Heather Han, MD
        • Sub-Investigator:
          • Roberto Diaz, MD, PhD
        • Sub-Investigator:
          • Iman Washington, MD
        • Sub-Investigator:
          • Hatem Soliman, MD
        • Contact:
        • Sub-Investigator:
          • Avan Armaghani, MD
        • Sub-Investigator:
          • John Arrington, MD
        • Sub-Investigator:
          • Ricardo Costa, MD, MSc
        • Sub-Investigator:
          • Hung Khong, MD
        • Sub-Investigator:
          • Kimberley Lee, MD, MHS
        • Sub-Investigator:
          • Loretta Loftus, MD, MBA
        • Sub-Investigator:
          • Marilin Rosa, MD
        • Sub-Investigator:
          • Aixa Soyano Muller, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stage IV breast cancer patients at Moffitt Cancer Center

Description

Inclusion Criteria:

  • Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
  • Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
  • Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
  • Age ≥ 18
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Patients must be able to understand and the willingness to sign an informed consent for study procedures
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  • Prior diagnosis or treatment of brain metastases or leptomeningeal disease
  • Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
  • Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
  • Indications warranting brain MRI for other neurologic conditions at time of study entry
  • Contraindication towards MRI imaging with contrast
  • Chronic kidney disease stage IV or V or end stage renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with TNBC (triple negative breast cancer)
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Diagnostic test: Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Other Names:
  • MRI
Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Diagnostic test: Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Other Names:
  • MRI
Participants with Hormone Receptor (HR) +Breast Cancer
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Diagnostic test: Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Brain Metastasis
Time Frame: at Baseline
Rate of brain metastasis by breast cancer subtype at baseline using MRI images.
at Baseline
Rate of Brain Metastasis
Time Frame: up to 6 months
Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Asymptomatic Leptomeningeal Disease
Time Frame: Baseline and at up to 6 months
Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images.
Baseline and at up to 6 months
Number of Brain Metastases
Time Frame: Baseline
Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.
Baseline
Overall Survival
Time Frame: Up to 6 months
Overall Survival (OS) will be measured from the initial on study date to the recorded date of death.
Up to 6 months
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation
Time Frame: Up to 6 months
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type.
Up to 6 months
Brain Metastasis Specific Survival
Time Frame: Up to 6 months
Brain metastasis specific survival following brain metastasis by breast cancer subtype
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Florida Breast Cancer Foundation

Investigators

  • Principal Investigator: Kamran A Ahmed, MD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-21448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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