# Validation of the MHC II Immune Activation Assay in Breast Cancer

> **NIH NIH UH3** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2022 · $351,220

## Abstract

Project Summary/Abstract
The development of clinical biomarker tests to assess risk of recurrence in ER+ breast cancer patients has led
to dramatic improvements in patient care and outcomes, including the de-escalation of chemotherapy and
reduction of adverse side-effects for women with good prognosis. There are currently no clinical biomarker tests
available to assess risk of recurrence in triple negative breast cancer (TNBC) patients or HER2+ breast cancer
patients. These patients are all treated with aggressive chemotherapy, and often suffer from long-term adverse
side-effects, because oncologists have no way of knowing which patients inherently have a good prognosis.
We recently discovered that expression of the MHC Class II antigen presentation pathway (MHCII) and the
presence of tumor infiltrating leukocytes (TILs) was associated with long-term disease-free survival (DFS) in
TNBC and HER2+ breast cancer patients. We developed a multigene expression assay compatible with formalin
fixed paraffin embedded breast tumor specimens that can accurately quantify MHCII expression and TILs to
generate an Immune Activation Score for each patient. We confirmed that the Immune Activation Score could
identify patients who have a very low risk of recurrence in an independent institutional cohort. Interestingly,
patients with high MHCII and TIL expression have long-term disease-free survival regardless of whether they
received chemotherapy. Additionally, mouse studies show that MHCII expression in tumors increases TILs and
protects from recurrence in the absence of chemotherapy, and other groups have recently reported that TNBC
patients with high TILs have improved DFS even without receiving chemotherapy. These data suggest that the
MHCII Immune Activation Assay can identify TNBC and HER2+ patients who have a very low risk of recurrence.
The primary objective of this UH3 proposal is to validate that the MHCII Immune Activation assay can be used
to identify TNBC and HER2+ breast cancer patients who have a very low risk of recurrence by analyzing clinical
trials specimens in a CLIA-certified laboratory. Specific Aim 1 analyzes tumors from a large trial of adjuvant
chemotherapy in TNBC and HER2+ patients, and Specific Aim 2 analyzes biopsies from TNBC patients who
received neoadjuvant chemotherapy (NAC). This ensures the assay is prognostic using different specimen types
and treatment timing. A secondary objective is to determine if the assay can identify good prognosis patients
who do equally well regardless of whether their chemotherapy regimens include paclitaxel. Exploratory
objectives include determining if high Immune Activation Scores are predictive of pathological complete response
to NAC, and determining if MHCII Immune Activation Scores change after NAC and are associated with DFS.
The successful completion of this study could produce the first biomarker assay for identifying TNBC and
HER2+ breast cancer patients who have a low risk of recurrence. It...

## Key facts

- **NIH application ID:** 10448167
- **Project number:** 1UH3CA262221-01A1
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** PHILIP S BERNARD
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $351,220
- **Award type:** 1
- **Project period:** 2022-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10448167

## Citation

> US National Institutes of Health, RePORTER application 10448167, Validation of the MHC II Immune Activation Assay in Breast Cancer (1UH3CA262221-01A1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10448167. Licensed CC0.

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