Breast Cancer, Triple-negative Breast Cancer
Conditions
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
Interventions
OTHERTempus assay
Blood collection
OTHERAdvanced pathology 1
Tissue procurement (from diagnostic biopsy)
OTHERAdvanced pathology 2
Tissue procurement (from research biopsy)
Sponsors
Laura Kennedy
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Kennedy, MD, PhD
Vanderbilt Medical Center
Outcome results
None listed