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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04308720

Enrollment

217

Registered

2020-03-16

Start date

2019-10-01

Completion date

2028-10-20

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in the ctDNA detection	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRobert W. Mutter, M.D.

Mayo Clinic Radiation Oncology

Outcome results