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

Suspended

• Conditions: Breast Cancer; Triple-negative Breast Cancer
• Interventions: Other: Tempus assay; Other: Advanced pathology 1; Other: Advanced pathology 2

• Registration Number: NCT04803084
• Lead Sponsor: Laura Kennedy

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Study Start: 2021-08-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Pathology	Advanced pathology 1	Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.
Advanced Pathology	Tempus assay	Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.
Advanced Pathology	Advanced pathology 2	Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.

Primary Outcome Measures

Name	Time	Method
Correlate diffusion weight imaging MRI characteristics	Baseline up to about 14 weeks
Correlate dynamic-contrast enhanced MRI characteristics	Baseline up to about 14 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States