# Precision Imaging of Breast Cancer for Guiding Neoadjuvant Endocrine Therapy

> **NIH NIH R01** · UNIVERSITY OF WISCONSIN-MADISON · 2022 · $605,718

## Abstract

Accurate non-invasive biomarkers are urgently needed to identify which patients with hormone
receptor positive (HR+) breast cancer will respond to neoadjuvant endocrine therapy. Lack of
direct knowledge of the endocrine sensitivity of each patient’s breast cancer impedes optimal,
tailored therapy. Without a more personalized approach, many women and men will continue to
suffer from the current morbidity and mortality of breast cancer. The overall objective of the
proposed clinical trial is to investigate the ability of quantitative, hybrid functional imaging for
assessing hormonal sensitivity, estrogen receptor (ER) functional inhibition, and early response
to neoadjuvant endocrine therapy. The long-term goal is to develop functional imaging
approaches to directly test tumor sensitivity to endocrine therapy in breast cancer patients for
individualized treatment plans and improved outcomes. The proposed research will investigate
early changes in expression of a classic estrogen-regulated target gene as a surrogate measure
of endocrine sensitivity: progesterone receptor (PR) using a progestin-based radioligand, 21-
[18F]fluorofuranylnorprogesterone (FFNP) and quantitative simultaneous breast positron
emission tomography/magnetic resonance imaging (PET/MRI). The central hypothesis is that
FFNP uptake in primary breast tumors will show dynamic changes in response to presurgical
endocrine therapy, which will correlate with treatment response and exceed inherent technical
variability. The proposed clinical trial is a prospective, single-center study that will enroll women
with newly diagnosed ER+/PR+/HER2- invasive breast cancer who will undergo simultaneous
breast PET/MRI with FFNP before and after a short course of endocrine therapy prior to surgical
excision. The study aims to determine 1) the efficacy of FFNP PET/MRI for predicting response
to presurgical endocrine therapy and 2) the quantitative reliability of FFNP breast PET/MRI. The
proposed research is innovative because it will use functional imaging with simultaneous breast
PET/MRI to improve the success of neoadjuvant endocrine therapy. Imaging treatment-induced
changes in estrogen-regulated signaling events, using FFNP PET/MRI, will have a significant
positive impact by enabling early assessment of endocrine therapy response mediated through
ER before changes in tumor size can be measured using conventional techniques such as
mammography, ultrasound, and palpation. Once validated, this approach can easily be
integrated into the preoperative evaluation of patients with primary HR+ breast cancer to
individualize neoadjuvant and adjuvant treatment plans for improved patient outcomes.

## Key facts

- **NIH application ID:** 10499509
- **Project number:** 1R01CA272571-01
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** Amy Fowler
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $605,718
- **Award type:** 1
- **Project period:** 2022-09-20 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10499509

## Citation

> US National Institutes of Health, RePORTER application 10499509, Precision Imaging of Breast Cancer for Guiding Neoadjuvant Endocrine Therapy (1R01CA272571-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10499509. Licensed CC0.

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