Clinical trial NCT04803084: Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment
Official title: Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Cancer
Triple-negative Breast Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and men at least 18 years of age that 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.

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

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.

Primary outcomes:
measure: Correlate dynamic-contrast enhanced MRI characteristics
timeFrame: Baseline up to about 14 weeks
measure: Correlate diffusion weight imaging MRI characteristics
timeFrame: Baseline up to about 14 weeks
Secondary outcomes:
measure: Evaluate association between MRI features and pathologic response
timeFrame: Baseline up to about 14 weeks
measure: Evaluate association between MRI features and recurrence-free survival
timeFrame: Baseline up to about 14 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Laura Kennedy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: