Breast Cancer Clinical Trial

Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment

Summary

This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.

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Full Description

Primary Objective:

- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent

Secondary Objective:

To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
To assess the prognostic potential of MRI features

Correlative:

To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response

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Eligibility Criteria

Inclusion Criteria:

Women and men at least 18 years of age.

Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
Be a candidate for MRI imaging.
Be willing to comply with scheduled visits required for the trial.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.

Poor visualization of the tumor on the initial breast MRI (investigator discretion)
Pregnant or nursing.

Study is for people with:

Breast Cancer

Estimated Enrollment:

10

Study ID:

NCT04803084

Recruitment Status:

Recruiting

Sponsor:

Laura Kennedy

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There is 1 Location for this study

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Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Vanderbilt-Ingram Service for Timely Access
Contact
800-811-8480
[email protected]
Laura Kennedy, MD, PhD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

10

Study ID:

NCT04803084

Recruitment Status:

Recruiting

Sponsor:


Laura Kennedy

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