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

Study Overview
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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.

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

Official Title
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Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer

Conditions
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Breast Cancer, Triple-negative Breast Cancer

Intervention / Treatment
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* Other: Tempus assay
* Other: Advanced pathology 1
* Other: Advanced pathology 2


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Pathology<br>Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response. | Other: Tempus assay<br>* Blood collection<br>Other: Advanced pathology 1<br>* Tissue procurement (from diagnostic biopsy)<br>Other: Advanced pathology 2<br>* Tissue procurement (from research biopsy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate dynamic-contrast enhanced MRI characteristics |  | Baseline up to about 14 weeks | 
| Correlate diffusion weight imaging MRI characteristics |  | Baseline up to about 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate association between MRI features and pathologic response |  | Baseline up to about 14 weeks | 
| Evaluate association between MRI features and recurrence-free survival |  | Baseline up to about 14 weeks |