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

NCT04308720 | Active Not Recruiting DMC

• 2 other identifiers: 19-003532ROR1931
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in the ctDNA detection

  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 Outcomes (1)

• Explore correlation of detectable ctDNA with invasive recurrence-free survival

  3 months post-treatment (treatment typically lasts 3-6 weeks)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert W. Mutter, M.D.

  Mayo Clinic Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: March 16, 2020
• Study Start: October 1, 2019
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): October 20, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

US (1)