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

Laura Kennedy

Status: Suspended

Conditions: Breast Cancer; Triple-negative Breast Cancer

Treatments: Other: Tempus assay; Other: Advanced pathology 2; Other: Advanced pathology 1

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04803084

P50CA098131 (U.S. NIH Grant/Contract)

VICC BRE 20104

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Advanced Pathology

Description:

Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.

Treatment:

Other: Advanced pathology 1

Other: Advanced pathology 2

Other: Tempus assay