Status:
SUSPENDED
Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment
Lead Sponsor:
Laura Kennedy
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Triple-negative Breast Cancer
Eligibility:
All Genders
18+ years
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04803084
Start Date
August 9 2021
End Date
August 1 2025
Last Update
November 20 2024
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232