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

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04308720

Run by

Mayo Clinic

People needed

217

Starts

2019-10-01

Expected to finish

2028-10-20

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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