# Project 02 - Non-invasive imaging metrics for determining non-response

> **NIH NIH P01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $339,057

## Abstract

ABSTRACT/SUMMARY
Increasing understanding of the heterogeneity of breast cancer is leading to tailored therapies that hold promise
for improving outcomes. The I-SPY2 TRIAL is a phase II, multicenter trial designed to test new treatment
strategies for breast cancer and to quickly identify promising candidate therapies for subsequent phase III testing.
MRI is used in I-SPY2 to monitor primary tumor response to neoadjuvant chemotherapy (NAC) and to provide
prognostic information. The overall objective of the Program Project is to develop and implement an adaptive
strategy to redirect NAC based on early treatment response indicators. The goal is to improve outcomes for
women with stage 2/3 breast cancer who remain at highest risk for recurrence, and minimize chemo-toxicities in
women at lowest risk. As a component of the Program Project, Project 2 will systematically develop integrated
imaging predictive models that can be used to decide mid-treatment modification of NAC based on individual
response. These models will be initially developed using the extensive existing DCE-MRI database in I-SPY2,
and augmented over time with imaging data emerging from more recent addition of DWI and PET. Information
from Project 3 about molecular determinants of treatment resistance will be used to further refine the prognostic
ability of imaging models. We will look more closely at the relationship between measures of residual disease by
MRI and histopathology, in order to further improve MRI's ability to serve as a non-invasive surrogate of residual
disease. Lastly, recognizing that PET imaging may provide additional insight into drug mechanism of action in
combination with MRI, we will begin to expand the use of PET through a pilot study performed at a sub-set of
sites using dedicated breast PET (dbPET) scanners. Project 2 leverages the substantial existing data set from
the multi-agent I-SPY2 clinical trial, consisting of serial MRIs linked to outcomes for over 1000 subjects receiving
experimental treatments. We expect the successful completion of aims to afford more powerful non-invasive
imaging methods that will facilitate the personalization of NAC and improve overall outcomes for patients with
breast cancer.

## Key facts

- **NIH application ID:** 10013138
- **Project number:** 5P01CA210961-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Nola M. Hylton-Watson
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $339,057
- **Award type:** 5
- **Project period:** 2017-09-08 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10013138

## Citation

> US National Institutes of Health, RePORTER application 10013138, Project 02 - Non-invasive imaging metrics for determining non-response (5P01CA210961-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10013138. Licensed CC0.

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