# Together: Transforming and Translating Discovery to Improve Health

> **NIH NIH UL1** · UNIVERSITY OF FLORIDA · 2021 · $195,137

## Abstract

Abstract: Breast cancer outcomes for Black women are inferior to their white non-Hispanic counterparts.
In addition, the University of Florida obtained data from four national cooperative
group trials demonstrating that for patients with breast cancer who receive neoadjuvant chemotherapy,
womenwho have residual breast disease (ypT+) have significantly inferior overall survival
and worsedistant recurrence, even with a pathologic complete response in the axilla (apCR).
Level I evidencedemonstrates regional nodal irradiation (RNI) improves distant metastasis-free
survival and overallsurvival for women with high risk node negative disease and clinical
node-positive disease. However,neoadjuvant chemotherapy has obfuscated the clear indications for
RNI and level I evidence with thattreatment strategy ispending; in the absence of level I data, many
use apCR to guide decisions. To thatend, our proposal consists of a three-aimed strategy to determine
retrospectively (Aim 1) and prospectively (Aim 2) if RNI improves overall survival in patients
with ypT+ breast cancer and (Aim3) determine if and how longitudinal changes in circulating
tumor DNA (ctDNA) across trimodality breastcancer curative treatment associate with cancer
outcome. For Aims 2 and 3,specific sub-aimsare to evaluate comparative outcomes between
Black women and non-Hispanic white counterparts.We will realize these goals through
retrospective analysis of national cooperative group data, aninterventional single-arm phase II trial
of RNI for women with ypT+ disease, and a prospective cohortstudy of women receiving curative
breast cancer treatment beginning with neoadjuvant chemotherapy.Aims 2 and 3 are
complementary such that women can enroll in one or both trials, allowing forheterogeneity in the
second aim to better explore how different treatments may affect ctDNA.Aim 1: Evaluate the benefit of
radiotherapy in women treated with neoadjuvant therapy on NSABP trials B-40 and B-41. Aim 2:
Evaluate the benefit of regional nodal irradiation in women withresidual breast disease after
neoadjuvant chemotherapy. Sub-Aim 2: Determine if the benefit of RNIin women with residual breast
disease after neoadjuvant chemotherapy differs between Black womenand non-Hispanic white
women. Aim 3: Measure the change in circulating tumor DNA longitudinallyfor women with PIK3CA
mutated invasive breast cancer completing all three modalities of treatment inthe course of
neoadjuvant chemotherapy -> surgery -> regional nodal irradiation. Sub-Aim 3: Measurein women
with invasive PIK3CA mutated breast cancer receiving triple modality care if circulating tumorDNA
their change differ between Black women and non-Hispanic whitewomen.
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## Key facts

- **NIH application ID:** 10294560
- **Project number:** 3UL1TR001427-07S1
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** DUANE A. MITCHELL
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $195,137
- **Award type:** 3
- **Project period:** 2015-08-15 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10294560

## Citation

> US National Institutes of Health, RePORTER application 10294560, Together: Transforming and Translating Discovery to Improve Health (3UL1TR001427-07S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10294560. Licensed CC0.

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