Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Other outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2028
Study completion: 2028
First posted: Mar 16, 2020
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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