# Rapid Response Monitoring with Circulating Tumor DNA in Metastatic Breast Cancer

> **NIH NIH R21** · BAYLOR COLLEGE OF MEDICINE · 2024 · $177,650

## Abstract

Project Summary
Breast cancer is the second most commonly diagnosed malignancy and distant spread to other organs is a
leading cause of cancer death. The treatment of metastatic breast cancer remains very challenging and requires
serial radiological monitoring to ensure that the patient is on the right treatment at the right time. This process
typically requires repeat CT or PET imaging scans which are expensive and subject patients to potential adverse
reactions, including contrast-related allergies and organ damage. The cost of radiological monitoring has
increased dramatically, at least as rapid as drug costs. Furthermore, because the radiological testing is relatively
infrequent, many stay on ineffective treatments too long. During this period the disease may progress, leaving
the patient under-treated with prolonged exposure to unnecessary toxicities and at significant cost burden,
especially with newer targeted-therapy drug classes. At the other end of the spectrum, patients with durable
response may be assigned to prolonged radiological imaging over the course of their management.
Genomic characterization of cancer has revolutionized our ability to decipher the complexities of tumor biology
and promote more precise cancer treatments. Advances in DNA sequencing have enabled the detection of
mutations in the tumor and now in tumor DNA that circulate in the blood (ctDNA). Cell-free circulating tumor
DNA has been proposed as a surrogate biological sample to define the genetic change(s) of a primary tumor
and/or metastatic disease in a cancer patient, and to serve as a biomarker for diagnosis, prognostication, and
monitoring of response to therapy. However, next generation sequencing (NGS) ctDNA panels are expensive
and are typically not reimbursed when used for serial monitoring of disease. In this application we propose a
low-cost strategy for dynamic molecular monitoring of metastatic breast cancer patients using bespoke digital
droplet PCR (ddPCR) assays constructed from a baseline NGS ctDNA test. We hypothesize that this hybrid
approach will offer a substantial lead-time over radiological detection of disease progression, allowing
for adaptive treatment changes that will reduce the time patients are exposed to ineffective treatment
and exposure to unnecessary toxicities. This cost-saving effort will substantially improve disease monitoring
in metastatic breast cancer patients, reduce toxicity associated with ineffective treatment, improve clinical trial
enrollment and serve as a viable approach to addressing cancer health inequities among underserved
populations with limited access to imaging due to the cost of these procedures.

## Key facts

- **NIH application ID:** 10823299
- **Project number:** 5R21CA280472-02
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** George Miles
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $177,650
- **Award type:** 5
- **Project period:** 2023-05-01 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10823299

## Citation

> US National Institutes of Health, RePORTER application 10823299, Rapid Response Monitoring with Circulating Tumor DNA in Metastatic Breast Cancer (5R21CA280472-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10823299. Licensed CC0.

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