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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-09

Study Completion Date

2025-08-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Breast Cancer Triple-negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Advanced Pathology

Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.

Tempus assay

Intervention Type OTHER

Blood collection

Advanced pathology 1

Intervention Type OTHER

Tissue procurement (from diagnostic biopsy)

Advanced pathology 2

Intervention Type OTHER

Tissue procurement (from research biopsy)

Interventions

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Tempus assay

Blood collection

Intervention Type OTHER

Advanced pathology 1

Tissue procurement (from diagnostic biopsy)

Intervention Type OTHER

Advanced pathology 2

Tissue procurement (from research biopsy)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No