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

SuspendedN/A

Sponsor: Laura Kennedy

Conditions: Breast Cancer, Triple-negative Breast Cancer

Interventions: Tempus assay, Advanced pathology 1, Advanced pathology 2

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (1)

Nashville, Tennessee, United States