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Suspended
NCT04803084
Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment
Conditions: Breast Cancer, Triple-negative Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 10
Sponsor: Laura Kennedy
Location: Vanderbilt University Medical Center Nashville Tennessee
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.
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.
Source: ClinicalTrials.gov (NCT04803084). StuddyBuddy aggregates publicly available trial information.