Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer

June 16, 2026 updated by: Mayo Clinic

Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer

This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women ages 18 and older with high-risk breast cancer with plan for adjuvant radiation therapy including the regional lymph nodes at Mayo Clinic.

Description

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.
  • Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=< 3 sites of metastases) is permitted
  • Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts
  • Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
  • Bilateral breast cancer is permitted
  • Positive or close margins is allowed

Exclusion Criteria:

  • Other active malignancy =< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)
  • Pregnancy or lactation
  • Inability on the part of the patient to understand the informed consent to be compliant with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the ctDNA detection
Time Frame: Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)
Assessed by the number of patients who have undetectable ctDNA post-treatment, among patients that were detectable pre-treatment.
Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore correlation of detectable ctDNA with invasive recurrence-free survival
Time Frame: 3 months post-treatment (treatment typically lasts 3-6 weeks)
Invasive recurrence is defined as the return of cancer after initial treatment, where the cancer has spread beyond the ducts or lobules into surrounding breast tissue
3 months post-treatment (treatment typically lasts 3-6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Robert W. Mutter, M.D., Mayo Clinic Radiation Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

October 20, 2028

Study Completion (Estimated)

October 20, 2028

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-003532
  • ROR1931 (Other Identifier: Mayo Clinic Radiation Oncology)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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